Clinical trial NCT02503332
Conditions: Geographic Atrophy
Sponsor: Apellis Pharmaceuticals, Inc.
Start date: 2015-09-24; Completion date: 2018-01-17
Enrollment: 246 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of pegcetacoplan in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).

Detailed description:
This is a Phase II, prospective, multicenter, randomized, single-masked, sham-controlled study to assess the safety, tolerability and evidence of activity of multiple IVT injections of pegcetacoplan in subjects with GA secondary to Age-Related Macular Degeneration.

The study will randomize approximately 240 subjects to obtain at least 200 evaluable subjects across 40 multinational sites.

Subjects will be randomized in a 2:2:1:1 manner to receive pegcetacoplan Monthly (AM), pegcetacoplan Every-Other-Month (AEOM), Sham injection Monthly (SM) or Sham injection Every-Other-Month (SEOM), respectively.

All subjects will return to the clinical site on Day 7 to assess acute safety after the first injection. After that, subjects in the monthly groups will return to the clinical site for additional pegcetacoplan (or Sham) injections and study procedures every month until Month 12. Subjects in the Every-Other-Month groups will return to the clinical site for additional pegcetacoplan (or Sham) injections and study procedures every two months until Month 12. All subjects will return for follow-up visits on Months 15 and 18 (3 and 6 months after last injection, respectively).

Arms: arm 1: A single dose of 15 mg pegcetacoplan/100 µL will be administered via intravitreal injection in this study. Subjects will receive an injection every month for 12 consecutive months. arm 2: A single dose of 15 mg pegcetacoplan/100 µL will be administered via intravitreal injection in this study. Subjects will receive an injection every other month (EOM) for 12 consecutive months. arm 3: Subjects will receive a Sham procedure every month for 12 consecutive months. arm 4: Subjects will receive a Sham procedure every other month (EOM) for 12 consecutive months.
Interventions: intervention 1: Pegcetacoplan intervention 2: Sham Procedure
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_000.pdf: 
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SAP_001.pdf: 

Statistical Analysis Plan


3DJHRI
Sponsor Name: 
Apellis Pharmaceuticals, Inc.
Protocol Number:  
 
POT-CP121614
Protocol Title:  
 
A Phase II, Multicenter, Randomized, Single-
Masked, Sham-controlled Study of Safety, 
Tolerability and Evidence of Activity of Intravitreal 
APL-2 Therapy in Patients with Geographic Atrophy 
(GA) - FILLY - 
Protocol Version and Date: 
3.0 ( 1st May 2017) 
2.0 (19th October 2015) 
1.0 (10th July 2015)
 

Author(s): 
 
 
SAP Version: 
Final v2.0
SAP Version Date: 
29 January 2018 (v3.0) 
09 August 2017 (v2.0) 
1st June 2017 (v1.0)
Notice of Confidential and Proprietary Information: 
This document is confidential. It contains proprietary information of Apellis Pharmaceutical, Inc. Any 
viewing or disclosure of such information that is not authorized in writing by Apellis Pharmaceutical, Inc is 
strictly prohibited. Such information may be used solely for the purpose of reviewing or performing this 
study. 
 
 
33'


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
Page 2 of 54 
Signature Page 
 
Protocol Number:   
POT-CP121614 
Protocol Title: 
A Phase II, Multicenter, Randomized, Single-Masked, Sham-controlled 
Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 
Therapy in Patients with Geographic Atrophy (GA) - FILLY - 
Version: 
Final v3.0 
Version Date: 
29 January 2018 
 
I confirm that I have reviewed this document and agree with the content. 
 
Author 
 
 
 
 
 
Date (dd-Mmm-yyyy) 
 
Approvals 
 
 
 
 
 
Apellis Pharmaceuticals, Inc. 
 
 
 
Date (dd-Mmm-yyyy) 
 
 
PPD
PPD


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
Page 3 of 54 
RATIONALE AND SUMMARY OF REVISION V3.0: 
The Statistical Analysis Plan (SAP) V2.0 is revised for the following reasons:  
• To add additional exploratory endpoints and analysis methods that are associated 
with 18-month data and addressing a different growth rate from visit to visit;  
• To add additional summary tables and figures for the added exploratory endpoints,  
and to remove redundant summary tables; 
• To clarify that all by-visit summaries and analyses of change from baseline over 
time for data up to Month 12 will be repeated to include all data up to Month 18 for 
the final analysis 18-month data;  
• To revise the numbering and titles of the planned summary tables, listings and 
figures (TLFs) to match those specified in the TLF Shells documents and modified 
upon the pre-database-lock review of 12-month data; and   
• Additional editorial changes across the document to improve clarity.  
 
RATIONALE AND SUMMARY OF REVISION V2.0: 
The Statistical Analysis Plan (SAP) is revised for the following reasons:  
• To specify that the CSR will be based on the primary 12-month data cut.  An 
addendum to the CSR will be generated with the final 18-month data; 
• To move anterior and posterior segment examinations from efficacy sections to 
safety sections; 
• To add a subgroup analysis of the primary endpoint by GA lesion size at baseline; 
• To remove redundant summary tables; 
• To change the comparison method from chi-squared test to Fisher’s exact test for 
incidence of macular neovascularization to handle the situation of low incidence in 
any group; 
• To specify that adverse events will be summarized separately for those occurs in 
the study eyes, in the fellow eye, and those that are non-ocular; 
• To add the summaries for prior/concomitant medications used in the study eyes, 
and for those used in the fellow eyes;  
• To modify the numbering and titles of the planned summary tables, listings and 
figures (TLFs) to match those specified in the TLF Shells documents; and   
• Additional editorial changes across the document to improve clarity.  
 
 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
Page 4 of 54 
TABLE OF CONTENTS 
1. 
GLOSSARY OF ABBREVIATIONS .............................................................................. 8 
2. 
INTRODUCTION ................................................................................................... 10 
2.1. 
Responsibilities ...................................................................................................................... 10 
3. 
STUDY OVERVIEW ............................................................................................... 10 
3.1. 
Study Objectives .................................................................................................................... 10 
3.2. 
Study Design .......................................................................................................................... 10 
3.3. 
Determination of Sample Size ................................................................................................. 11 
3.4. 
Treatment Assignment and Blinding ....................................................................................... 12 
3.5. 
Administration of Study Medication ....................................................................................... 12 
3.6. 
Study Flowchart ..................................................................................................................... 14 
4. 
ENDPOINTS ......................................................................................................... 17 
4.1. 
Primary Efficacy Endpoint ....................................................................................................... 17 
4.2. 
Secondary and Exploratory Efficacy Endpoints ........................................................................ 17 
4.2.1. 
Best-Corrected Visual Acuity (BCVA) .................................................................................... 17 
4.2.2. 
Macular Neovascularization (MNV) ..................................................................................... 18 
4.2.3. 
Low Luminance Best-Corrected Visual Acuity (LL-BCVA) ........................................................ 18 
4.2.4. 
Low Luminance Visual Acuity (LL-VA) Deficit ......................................................................... 18 
4.2.5. 
Foveal Encroachment (Distance of GA Lesion from Fovea) ..................................................... 19 
4.2.6. 
Drusen Size ........................................................................................................................ 19 
4.2.7. 
GA Lesion Size Measured by SD-OCT .................................................................................... 19 
4.2.8. 
Genetic Polymorphisms ...................................................................................................... 19 
4.3. 
Safety Endpoints .................................................................................................................... 20 
4.3.1. 
Adverse Events .................................................................................................................. 20 
4.3.2. 
Intraocular pressure (IOP) ................................................................................................... 20 
4.3.3. 
Anterior Segment Examination ............................................................................................ 21 
4.3.4. 
Posterior Segment Examination .......................................................................................... 21 
4.3.5. 
LOCS III Lens ...................................................................................................................... 21 
4.3.6. 
Other Safety Endpoints ....................................................................................................... 22 
4.4. 
Pharmacokinetic Endpoints .................................................................................................... 22 
4.5. 
Pharmacodynamic Endpoints ................................................................................................. 22 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
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5. 
ANALYSIS SETS ..................................................................................................... 22 
5.1. 
Screened Population .............................................................................................................. 22 
5.2. 
Randomized Population ......................................................................................................... 23 
5.3. 
Safety Population .................................................................................................................. 23 
5.4. 
Intent to Treat (ITT) Population .............................................................................................. 23 
5.5. 
Modified Intent to Treat (mITT) Population ............................................................................. 23 
5.6. 
Per Protocol (PP) Population .................................................................................................. 23 
5.7. 
Pharmacokinetic (PK) Population ............................................................................................ 24 
5.8. 
Pharmacodynamic (PD) Population ......................................................................................... 24 
5.9. 
Protocol Deviations ................................................................................................................ 24 
5.10. 
Data Review for Analysis Populations ..................................................................................... 24 
6. 
GENERAL ASPECTS FOR STATISTICAL ANALYSIS .................................................... 25 
6.1. 
General Methods ................................................................................................................... 25 
6.2. 
Missing Data .......................................................................................................................... 26 
6.2.1. 
Efficacy Data ...................................................................................................................... 26 
6.2.2. 
Pharmacokinetic and Pharmacodynamic Data ...................................................................... 27 
6.3. 
Visit Windows ........................................................................................................................ 27 
7. 
DEMOGRAPHIC, OTHER BASELINE CHARACTERISTICS AND MEDICATION .............. 28 
7.1. 
Patient Disposition and Withdrawals ...................................................................................... 28 
7.2. 
Demographic Characteristics .................................................................................................. 29 
7.3. 
Baseline Characteristics .......................................................................................................... 29 
7.4. 
Medical History and Concomitant Diseases ............................................................................. 29 
7.5. 
Prior and concomitant Medications ........................................................................................ 30 
7.6. 
Extent of Exposure ................................................................................................................. 30 
8. 
EFFICACY ............................................................................................................. 31 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
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8.1. 
Primary Efficacy Endpoint and Analysis ................................................................................... 31 
8.1.1. 
Sensitivity Analyses of the Primary Endpoint ........................................................................ 32 
8.1.2. 
Additional Analyses of the Primary Endpoint ........................................................................ 33 
8.1.3. 
GA Lesion Growth Rate between Timepoints of Interest ................................................ 33 
8.2. 
Secondary and Exploratory Efficacy Endpoints and Analysis ..................................................... 34 
8.2.1. 
Best-Corrected Visual Acuity (BCVA) .................................................................................... 34 
8.2.2. 
Macular Neovascularization (MNV) ..................................................................................... 35 
8.2.3. 
Low Luminance Best-Corrected Visual Acuity (LL-BCVA) ........................................................ 35 
8.2.4. 
Low Luminance Visual Acuity (LL-VA) Deficit ......................................................................... 36 
8.2.5. 
Foveal Encroachment (Distance of GA Lesion from Fovea) ..................................................... 36 
8.2.6. 
Drusen Size ........................................................................................................................ 37 
8.2.7. 
GA Lesion Size Measured by SD-OCT .................................................................................... 37 
8.2.8. 
Genetic Polymorphisms ...................................................................................................... 37 
8.2.9. 
Other Ophthalmology Data ................................................................................................. 37 
9. 
ANALYSIS OF PHARMACOKINETICS ...................................................................... 38 
9.1. 
Concentration data ................................................................................................................ 38 
9.2. 
Pharamcokinetic data ............................................................................................................ 38 
10. 
ANALYSIS OF PHARMACODYNAMICS................................................................ 38 
11. 
SAFETY ............................................................................................................ 39 
11.1. 
Adverse Events ...................................................................................................................... 39 
11.2. 
Intra Ocular Pressure (IOP) ..................................................................................................... 40 
11.3. 
Anterior Segment Examination ............................................................................................... 40 
11.4. 
Posterior Segment Examination .............................................................................................. 40 
11.5. 
LOCS III Lens .......................................................................................................................... 41 
11.6. 
Laboratory Evaluations .......................................................................................................... 41 
11.7. 
Antigenicity Data ................................................................................................................... 41 
11.8. 
Vital Signs .............................................................................................................................. 42 
12. 
INTERIM ANALYSES .......................................................................................... 42 
13. 
CHANGE FROM ANALYSIS PLANNED IN PROTOCOL ........................................... 42 
14. 
REFERENCES .................................................................................................... 44 
15. 
INDEX OF TABLES AND FIGURES ....................................................................... 45 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
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16. 
INDEX OF LISTINGS ........................................................................................... 53 
 
 
 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
Page 8 of 54 
1. 
GLOSSARY OF ABBREVIATIONS 
Abbreviation 
Description 
ACR 
Albumin Creatinine Ratio 
AE 
Adverse Event 
AM 
APL-2 Monthly 
AEOM 
APL-2 Every-Other-Month 
AESI 
Adverse Event of Special Interest 
AMD 
Age-related Macular Degeneration 
ANCOVA 
Analysis of Covariance 
ATC 
Anatomic Therapeutic Chemical 
AUC 
Area Under the Curve 
BCVA 
Best-Corrected Visual Acuity 
BLQ 
Below Limit of Quantification 
CNS 
Clinical Network Services Pty Ltd 
CNV 
Choroidal Neovascularization 
CRC 
Central Reader Centre 
CSR 
Clinical Study Report 
CV 
Coefficient of Variation 
eCRF 
Electronic Case Record Form 
EOM 
Every Other Month 
FFA 
Fundus Fluorescein Angiograms 
FAF 
Fundus Autoflourescence Photographs 
GA 
Geographic Atrophy 
ITT 
Intent To Treat 
IOP 
Intra Ocular Pressure 
IR 
Infrared Reflectance 
IV 
Intravenous 
IVT 
Intravitreal 
IWRS 
Interactive Web Response System 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
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Abbreviation 
Description 
LL-BCVA 
Low Luminance Best-Corrected Visual Acuity  
LLOQ 
Lower Limit of Quantification 
LL-VA 
Low Luminance Visual Acuity 
logMAR 
log10 of the Minimal Angle of Resolution 
MCMC 
Markov Chain Monte Carlo 
MedDRA 
Medical Dictionary for Regulatory Activities 
MITT 
Modified Intent To Treat 
MMRM 
Mixed effects Model for Repeated Measures 
MNV 
Macular Neovascularization 
PD 
Pharmacodynamics 
PK 
Pharmacokinetics 
PP 
Per protocol 
PT 
Preferred Term 
REML 
Restricted Maximum Likelihood 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SD-OCT 
Spectral Domain Optical Coherence Tomography 
SEOM 
Sham Every-Other-Month 
SM 
Sham Monthly 
SMC 
Safety Monitoring Committee 
SOC 
System Organ Class 
TEAE 
Treatment Emergent Adverse Event 
TLFs 
Tables, Listings, Figures 
WHO 
World Health Organization 
 
 
 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
Page 10 of 54 
2. 
INTRODUCTION 
This statistical analysis plan (SAP) for study POT-CP121614 is developed based on the final protocol 
version 3.0 and CRF version (20th January 2016). The purpose of this SAP is to ensure that the data 
listings, summary tables and figures which will be produced, and the statistical methodologies that 
will be used, are comprehensive and appropriate for the analysis of study objectives specified in 
the protocol.  Any amendments to the SAP will be made prior to database lock. Any additional 
analyses not described in the final SAP or deviations from the final SAP will be documented in the 
clinical study report (CSR). 
This SAP supersedes the protocol in all specifications associated with data analyses and statistical 
methodologies. 
Study POT-CP121614 has a 12-month treatment period with an additional 6-month follow-up 
period.  The main database lock for the study will occur when all subjects complete the Month 12 
visit or have withdrawn earlier from the study and the data have been collected and cleaned.  The 
CSR will summarize data up to 12 months.  All post Month 12 follow-up data collected prior to the 
database lock may be presented on key safety outcomes.  When all subjects complete the study 
(i.e. the final follow-up visit at Month 18) or have withdrawn earlier from the study and all data are 
collected and cleaned, the final database lock will occur.  An addendum to the CSR will be developed 
to summarize the additional follow-up data.   For key endpoints, the summary will include data for 
the overall study period (treatment + follow-up). 
2.1. 
RESPONSIBILITIES 
All genotyping analyses will be performed and reported by The Institute of Human Genetics at the 
University of Regensburg. Clinical Network Services Pty Ltd (CNS) will perform the statistical 
analyses of all other endpoints and are responsible for the production and quality control of tables, 
figures and listings (TLFs) for these endpoints.  
3. 
STUDY OVERVIEW 
3.1. 
STUDY OBJECTIVES 
The primary objectives of the study are to assess the safety, tolerability and evidence of activity of 
multiple intravitreal (IVT) injections of APL-2 in subjects with Geographic Atrophy (GA) associated 
with Age-related Macular Degeneration (AMD). 
3.2. 
STUDY DESIGN 
This is a Phase II, prospective, multicenter, randomized, single-masked, sham-controlled study to 
assess the safety, tolerability and evidence of activity of multiple IVT injections of APL-2 in subjects 
with GA associated with AMD.  


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
Page 11 of 54 
Subjects diagnosed with GA associated with AMD in the study eye and who meet all 
inclusion/exclusion criteria will be included in the study. The study will randomize approximately 
240 subjects across 40 multinational sites to obtain at least 200 subjects who complete the study. 
Subjects should be screened 14 (±5) days before receiving APL-2. Subjects who meet all inclusion 
and exclusion criteria and are confirmed as eligible by the Central Reader Centre (CRC) will return 
to the clinic for the randomization visit (Day 1). At this visit, subjects will be randomized in a 2:2:1:1 
manner to receive APL-2 Monthly (AM), APL-2 Every-Other-Month (AEOM), Sham injection Monthly 
(SM) or Sham injection Every-Other-Month (SEOM), respectively.  
All subjects will return to the clinical site on Day 7 to assess acute safety after the first injection. 
After that, subjects in the monthly groups will return to the clinical site for additional APL-2 (or 
Sham) injections and study procedures every month until Month 12. Subjects in the EOM groups 
will return to the clinical site for additional APL-2 (or Sham) injections and study procedures every 
two months until Month 12. All subjects will return for follow-up visits 3 and 6 months after Month 
12 (Months 15 and 18, respectively). 
Subjects who discontinue study treatment, can continue participation in the study and return to 
the clinical site for their scheduled study procedures (with the exception of APL-2/Sham 
administration).  Subjects who fully withdraw from the study before Month 12, should complete 
the Termination Visit. 
Safety will be assessed throughout the study; serial blood samples and urine samples will be 
collected. Blood samples will also be collected for the PK assessment of APL-2. 
An external, independent Safety Monitoring Committee (SMC) will review cumulative unmasked 
safety data and will have the responsibility to conduct a thorough safety assessment after the first 
20 subjects have completed the Day 7, Month 2 and Month 6 visits. A key responsibility of the SMC 
will be to make a recommendation whether to continue, modify or stop the study based upon an 
evaluation of emerging safety data, in particular Adverse Events of Special Interest (AESI outlined 
in Protocol Section 10.1.3). Additional regular or ad-hoc safety reviews will be scheduled as 
recommended by the SMC. 
The planned length of participation in the study for each subject is approximately 18.5 months 
(from Day –14 through completion of the Month 18 [Day 540] follow-up procedures).  
3.3. 
DETERMINATION OF SAMPLE SIZE 
With a total sample size of 201 evaluable subjects there is approximately 90% power to claim a 
statistically significant difference in means among treatment groups if there is a ‘true’ 30% 
reduction in annual increase of square root GA area for the APL-2 treated groups compared with 
the pooled sham treatment group.  This assumes that, in the absence of treatment, average square 
root area change is 0.33mm/year1,2, the standard deviation of annual square root area change is 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
Page 12 of 54 
0.2mm/year and a 2-sided test at the 10% level of significance. 
Assuming a 15-20% loss to follow-up, a total sample size of 240 subjects (AM=80, AEOM=80, SM=40 
and SEOM=40) will be required to obtain 201 evaluable subjects (i.e. subjects who complete the 
study). 
3.4. 
TREATMENT ASSIGNMENT AND BLINDING 
Each subject will be assigned a unique screening number upon entering screening.  Subjects who 
complete the study screening assessments and meet all eligibility criteria will be scheduled to enter 
the study and be randomized. The randomization of subjects will be done via a web-based 
randomization system (IWRS) which will assign a unique randomization number. Subjects will be 
randomized in a 2:2:1:1 ratio to receive APL-2 monthly (AM), APL-2 every-other-month (AEOM), 
sham injection monthly (SM) or sham injection every-other-month (SEOM), respectively. The 
randomization will be stratified by site. 
The study is single-masked. Subjects and assessors of efficacy assessments (imaging or visual acuity) 
are masked to treatment (APL-2 or sham injection). The investigators, site personnel not 
performing efficacy assessments, vendors, sponsor and CRO personnel will be unmasked to 
treatment assignment.  Additionally the CRC, who will perform the independent review of efficacy 
evaluation images, will be masked to provide an objective assessment of these evaluations. 
The independent SMC will be provided unmasked safety data for their safety assessment. 
Masking will be maintained throughout the conduct of the study. In the event of a medical 
emergency where the knowledge of subject treatment by masked individuals (e.g. the subject or 
his/her physician) is required, an individual Investigator will have the ability to unmask the 
treatment assignment for a specific subject and share that information with the appropriate 
parties. The Investigator must endeavour to notify the Sponsor prior to unmasking a subject. 
3.5. 
ADMINISTRATION OF STUDY MEDICATION 
Subjects will receive either 15mg APL-2/100 µL IVT injections or sham injections.  Injections will 
either be monthly or EOM depending on the treatment group. The number of injections for each 
treatment group is: 
Table 1: Number of Injections 
Treatment Arm 
Number of Injections 
APL-2 Monthly for 12 months 
13 
APL-2 EOM for 12 months 
7 
Sham Monthly for 12 months 
13 
Sham EOM for 12 months 
7 
 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
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APL-2 injections will be administered using a 29G or 27G thin wall needle, at the discretion of the 
investigator. The procedure for the sham injection will be the same as that used for IVT injection 
until the actual injection; no actual injection will occur.  Detailed instructions on drug preparation, 
pre-injection procedures, administration of APL-2, sham injections and post-injection procedures 
are provided in the manual of procedures for this study. 
To minimize intra ocular pressure (IOP) elevation after IVT injection of APL-2, decompression of the 
eye must be performed before all APL-2 (or sham) injections. This is done by applying moderate 
pressure to the globe with cotton swabs for 30-60 seconds during anaesthetic preparation. 


Apellis Pharmaceuticals, Inc. 
 
Date: 1st June 2017 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
   
Page 14 of 54 
3.6. 
STUDY FLOWCHART 
 Monthly Groups Visit Schedule 
  
Screening 
Treatment 
FU 
Termin. 
Visit #  
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
Day 
-14 
0 
7 
30 
60 
90 
120 
15
0 
180 
210 
240 
270 
300 
330 
360 
450 
540 
Deviation Allowed (+ or - days) 
5 
0 
2 
6 
6 
6 
6 
6 
6 
6 
6 
6 
6 
6 
6 
14 
14 
Month 
-0.5 
0 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
15 
18 
Informed Consent / Assign Screening Number  
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demographic Data 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria A 
x 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical/Ocular History 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Blood Draw – Safety Labs B 
x 
 
 
 
x 
 
 
 
x 
 
 
 
 
 
x 
 
x 
Urine Sample Collection 
x 
 
 
 
x 
 
 
 
x 
 
 
 
 
 
x 
 
x 
Blood Draw - PK and Anti-APL-2 Ab 
x 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
X 
x 
x 
x 
Blood Draw – Genotyping (if applicable) C 
 
 
 
 
x 
 
 
 
 
 
 
 
 
 
 
 
 
Vital Signs D 
x 
X 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
X 
x 
x 
x 
Urine Pregnancy Test E 
 
 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
X 
x 
x 
x 
BCVA 
x 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
SE 
x 
LL-BCVA 
x 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
SE 
x 
IOP Measurement 
x 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
Slit Lamp Examination 
x 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
LOCS III Lens Grading F 
x 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
Dilated Binocular Indirect Ophthalmoscopy 
x 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
SD-OCT G 
x 
 
 
 
SE 
 
 
 
SE 
 
 
 
 
 
SE 
 
x 
Fundus Autofluorescence Photographs (FAF) G 
x 
 
 
 
x 
 
 
 
x 
 
 
 
 
 
x 
 
x 
Infrared Reflectance (IR) G 
x 
 
 
 
x 
 
 
 
x 
 
 
 
 
 
x 
 
x 
Digital Color Fundus Photographs (DCFP) 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
Fundus Fluorescein Angiograms (FFA) 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
x 
Study Eye Determination 
x 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
APL-2 administration or Sham Injection 
 
X 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
Post-Injection Assessment H 
 
X 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
Concomitant Medication / Adverse Events 
 
X 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
SE= Study eye only 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
Statistical Analysis Plan 
 
 
 
SAP Version Final v3.0    
 
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Every-Other-Month (EOM) Groups Visit Schedule 
  
Screening 
Treatment 
FU 
Termin. 
Visit #  
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
Day 
-14 
0 
7 
60 
120 
180 
240 
300 
360 
450 
540 
Deviation Allowed (+ or - days) 
5 
0 
1 
6 
6 
6 
6 
6 
6 
14 
14 
Month 
-0.5 
0 
0 
2 
4 
6 
8 
10 
12 
15 
18 
Informed Consent / Assign Screening Number 
X 
 
 
 
 
 
 
 
 
 
 
Demographic Data 
X 
 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria A 
X 
x 
 
 
 
 
 
 
 
 
 
Medical/Ocular history 
X 
 
 
 
 
 
 
 
 
 
 
Blood Draw – Safety Labs B 
X 
 
 
x 
 
x 
 
 
x 
 
x 
Urine Sample Collection 
X 
 
 
x 
 
x 
 
 
x 
 
x 
Blood Draw - PK and Anti-APL-2 Ab 
X 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Blood Draw – Genotyping (if applicable) C 
 
 
 
x 
 
 
 
 
 
 
 
Vital Signs D 
X 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Urine Pregnancy Test E 
 
 
 
x 
x 
x 
x 
x 
x 
x 
x 
BCVA 
X 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
SE 
x 
LL-BCVA 
X 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
SE 
x 
IOP Measurement 
X 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
Slit Lamp Examination 
X 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
LOCS III Lens Grading F 
X 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
Dilated Binocular Indirect Ophthalmoscopy 
X 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
SE 
x 
SD-OCT G 
X 
 
 
SE 
 
SE 
 
 
SE 
 
x 
Fundus Autofluorescence Photographs (FAF) G 
X 
 
 
x 
 
x 
 
 
x 
 
x 
Infrared Reflectance (IR) G 
X 
 
 
x 
 
x 
 
 
x 
 
x 
Digital Color Fundus Photographs (DCFP) 
X 
 
 
 
 
 
 
 
 
 
x 
Fundus Fluorescein Angiograms (FFA) 
X 
 
 
 
 
 
 
 
 
 
x 
Study Eye Determination 
X 
 
 
 
 
 
 
 
 
 
 
Randomization   
 
x 
 
 
 
 
 
 
 
 
 
APL-2 administration or Sham injection 
 
x 
 
x 
x 
x 
x 
x 
x 
 
 
Post-Injection Assessment H 
 
x 
 
x 
x 
x 
x 
x 
x 
 
 
Concomitant Medication / Adverse Events 
 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
SE= Study eye only 


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Date: 29 January 2018 
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A. 
On visit 2, review inclusion/exclusion and confirm eligibility by the Central Reading Center (CRC). 
B. 
Includes HCG for WOCBP and FSH/LH blood for postmenopausal females at screening. 
C. 
Genotyping will only be performed at selected sites. 
D. 
On injection visits, vital signs will be measured within approximately 1 hour prior to dosing and within 30 minutes after dosing. 
E. 
Only WOCBP 
F. 
If a lens finding is noted during the slit-lamp examination, at any visit, then the finding should be further characterized with LOCS III. All subsequent visits for that 
patient should include LOCS III. 
G. 
On injection visits, SD-OCT, FAF and IR should be performed before APL-2 (or Sham) administration. IR will only be done at selected clinical sites with Heidelberg 
Spectralis® system. 
H. 
Initial assessment must be done within 15 minutes after dosing. Additional assessments should be done every approximately 30 minutes, if needed. 
Note:  The study schedule refers to the first day of dosing as Day 0 (Visit 2). For reporting purposes CDISC standards will be used and therefore it is necessary to refer to the 
first day of dosing as Day 1. Consequently, throughout the SAP text Day 1 is referred to as the first day of dosing, however the study schedule table is taken directly from 
the protocol and has not been changed.


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Date: 1st June 2017 
POT-CP121614                                                                         
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4. 
ENDPOINTS 
4.1. 
PRIMARY EFFICACY ENDPOINT 
The primary endpoint is the annual growth rate of GA area in the study eye as measured by the 
mean change in square root area of GA lesion from baseline to Month 12 based on the Fundus 
Autoflourescence Photographs (FAF).  Baseline will be taken as the last available non-missing 
assessment prior to first study drug administration, this should be the screening assessment for the 
primary endpoint. 
A secondary endpoint will investigate the untransformed value collected i.e. mean change in area 
of GA lesion from baseline to Month 12 based on the FAF. 
Upon reviewing the 12-month results, different growth rates in the GA lesion were observed across 
visit to visit.  Therefore, the change in GA lesion from Month 6 to Months 12 and 18, and the change 
from Month 12 to Month 18 will be evaluated as exploratory endpoints.  The analyses will be 
performed for both square root transformed and untransformed measurements of the GA lesion.  
4.2. 
SECONDARY AND EXPLORATORY EFFICACY ENDPOINTS 
4.2.1. 
Best-Corrected Visual Acuity (BCVA) 
BCVA is performed following refraction by a certified VA examiner and is done prior to any 
examination requiring administration of eye drops to dilate the eye or any examination requiring 
contact with the eye. Larger values indicate better visual acuity.  BCVA is the sum of BCVA1 (correct 
identifications at 1 meter) and BCVA4 (correct identifications at 4 meters). If BCVA1 is not collected 
because visual acuity has been identified as 20/200 or better at the 4-meter test, then a value of 
30 will be used in the calculation of BCVA. 
The endpoint is change from baseline in BCVA.  Baseline will be taken as the last available non-
missing assessment prior to first study drug administration.  The change from baseline will also be 
categorized as follows: 
• 
≥15 letters improvement from baseline 
• 
≥10 letters and <15 letters improvement from baseline 
• 
≥5 letters and <10 letters improvement from baseline 
• 
Minimal change from baseline; defined as -4 to 4 letters  
• 
≥5 letters and <10 letters worsening from baseline 
• 
≥10 letters and <15 letters worsening from baseline 
• 
≥15 letters worsening from baseline 
 
The Snellen equivalent value is also collected as part of the BCVA assessment. The Snellen 
equivalent categorical response at each visit will be investigated. In addition, the Snellen value will 


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Date: 29 January 2018 
POT-CP121614                                                                         
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be transformed to log10 of the reciprocal of the Snellen value, this is more commonly known as log10 
of the minimal angle of resolution value (logMAR).  The converted logMAR scores will be rounded 
to one decimal. For a Snellen value of 20/20 logMAR is 0 and as vision worsens logMAR increases 
and as vision improves logMAR decreases.  A change of 0.1 on the logMAR scale represents a change 
of 1 line.  The change from baseline in logMAR will be investigated. 
 
4.2.2. 
Macular Neovascularization (MNV) 
The incidence of MNV in the study eye will be investigated.  A clinical review of all ocular adverse 
events will be performed prior to database lock to identify all cases of MNV. 
4.2.3. 
Low Luminance Best-Corrected Visual Acuity (LL-BCVA)  
LL-BCVA is performed by a certified VA examiner and is done prior to any examination requiring 
administration of eye drops to dilate the eye or any examination requiring contact with the eye. 
Larger values indicate better visual acuity. LL-BCVA is the sum of LL-BCVA1 (correct identifications 
at 1 meter) and LL-BCVA4 (correct identifications at 4 meters). If LL-BCVA1 is not collected because 
the low luminance visual acuity has been identified as 20/200 or better at the 4-meter test, then a 
value of 30 will be used in the calculation of LL-BCVA. 
The endpoint is change from baseline in LL-BCVA.  Baseline will be taken as the last available non-
missing assessment prior to first study drug administration.  The change from baseline will also be 
categorized as follows: 
• 
≥15 letters improvement from baseline 
• 
≥10 letters and <15 letters improvement from baseline 
• 
≥5 letters and <10 letters improvement from baseline 
• 
Minimal change from baseline; defined as -4 to 4 letters  
• 
≥5 letters and <10 letters worsening from baseline 
• 
≥10 letters and <15 letters worsening from baseline 
• 
≥15 letters worsening from baseline 
The Snellen equivalent value is also collected as part of the LL-BCVA assessment. The Snellen 
equivalent categorical response at each visit will be investigated. In addition, the Snellen value will 
be transformed to logMAR (as described in Section 4.2.1).  The change from baseline in logMAR will 
be investigated. 
4.2.4. 
Low Luminance Visual Acuity (LL-VA) Deficit 
The LL-VA deficit is calculated as BCVA minus LL-BCVA. The endpoint of interest is change from 
baseline in LL-VA deficit. Baseline will be taken as the last available non-missing assessment prior 
to first study drug administration. Baseline LL-VA deficit should be derived from BCVA and LL-BCVA 


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Date: 29 January 2018 
POT-CP121614                                                                         
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at the same time point for each subject; otherwise baseline LL-VA deficit will be set to missing.  
4.2.5. 
Foveal Encroachment (Distance of GA Lesion from Fovea) 
Foveal encroachment over time in the study eye, as measured by FAF, will be assessed by change 
from baseline in distance of GA lesion from fovea. Baseline will be taken as the last available non-
missing assessment prior to first study drug administration. 
4.2.6. 
Drusen Size 
Drusen is assessed in both eyes by color photography at screening and end of study or early 
termination.  Baseline will be taken as the last available non-missing assessment prior to first study 
drug administration. The endpoints are: 
• 
Study eye drusen size (none, small, intermediate or large). The maximum size recorded will 
be used.  So for example if both intermediate and large drusen are recorded then the size 
will be large. The size will be assigned as small if there are drusen present but none are 
intermediate or large. 
• 
The number of intermediate or large drusen recorded in the study eye (0-5, 6-10, 11-20 or 
>20). 
4.2.7. 
GA Lesion Size Measured by SD-OCT 
In this study, Spectral Domain Optical Coherence Tomography (SD-OCT) is measured by one of two 
machines (Ziess Cirrus or Heidelberg Spectralis). The same machine is used for a subject throughout 
the study. Note: approximately 80% of subjects have been assessed using the Spectralis machine.  
Depending on data availability, GA lesion size per SD-OCT will be investigated for those subjects 
who have SD-OCT assessed with the Cirrus machine.  The endpoint is change from baseline in 
square root area for GA lesion in the study eye as measured by SD-OCT.  Baseline will be taken as 
the last available non-missing assessment prior to first study drug administration. 
4.2.8. 
Genetic Polymorphisms 
Genetic marker analysis will be performed on blood samples collected at Month 2 for all subjects 
at selected sites where genetic testing is allowed. The prioritized genes, C3, CFI, CFH, CFB, C2, 
ARMS2/HTRA1, will be explored to assess whether they are prognostic/predictive factors of the 
growth in GA area and the APL-2 treatment.  For the prioritized genes the following SNPs, that have 
been highly associated with AMD, will be investigated: 
• 
CFH: rs1061170, rs1410996, rs10737680, rs1048663  
• 
CFB: rs438999, rs541862, rs4151667, rs641153  
• 
C2: rs9332739  


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Date: 29 January 2018 
POT-CP121614                                                                         
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• 
C2/CFB: rs429608  
• 
CFI: rs17440077, rs4698775, rs10033900  
• 
ARMS2/HTRA1: rs10490924  
• 
C3: rs2230199 
Additional genes that are not part of the current scope of work may be analysed and summarized 
in a separate genetic report. 
4.3. 
SAFETY ENDPOINTS 
4.3.1. 
Adverse Events 
The primary safety endpoints for the study are the number and severity of treatment emergent 
adverse events (TEAEs) and adverse events of special interest (AESI).  AESI will be identified on the 
eCRF at the time of reporting and include: 
• 
Endophthalmitis 
• 
4+ ocular inflammation 
• 
2-3+ ocular inflammation that fails to decrease to 1+ or less within 30 days of the onset of 
the event 
• 
Sustained (> 5 minutes) loss of light perception after APL-2 (or Sham) injection 
• 
Sustained elevation of IOP (30 mmHg) at/past 90 minutes post-injection 
• 
Any elevation of IOP requiring surgical intervention (i.e. paracentesis) 
• 
New vitreous hemorrhage of > 2+ severity that does not resolve within 14 days of the onset 
of the event 
• 
Progression to exudative (wet) AMD in the study eye or fellow eye requiring surgical 
intervention (Note: Intravitreal administration of anti-VEGF agents are not considered 
surgical interventions.) 
A clinical review of all ocular AEs will be performed prior to database lock to ensure all AESI have 
been identified. 
4.3.2. 
Intraocular pressure (IOP)  
Intraocular pressure (IOP) will be measured using either Tonopen, iCare or Goldmann applanation 
tonometer. The same method will be used for all measurements in the same subject throughout 
the study.  IOP is collected for the study eye pre and post injection at each study visit.   
A safety endpoint for IOP is change from baseline in study eye IOP over time. Baseline will be taken 
as the last available non-missing assessment prior to first study drug administration.    
The acute change in IOP after each injection (i.e., change from pre-injection to post-injection value) 
will also be analysed as another endpoint for IOP.  Missing pre-injection IOP values will be imputed 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
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with the last available pre-injection IOP value at previous visits.  Missing post-injection values will 
not be imputed. 
Values ≥30 mmHg will also be identified.  Missing IOP values will not be imputed for this indicator 
endpoint. 
4.3.3. 
Anterior Segment Examination 
The anterior segment examination data is collected on the slit lamp examination eCRF page. The 
anterior segment examination is performed throughout the study for the study eye and at 
screening and end of study only for the fellow eye. The following endpoints will be investigated for 
the study eye and fellow eye (screening and end of study only): 
• 
Abnormal reaction to light 
• 
Active inflammation present in cornea 
• 
Abnormal anterior chamber 
• 
Any opacity in lens. Note if response to lens question is missing but anterior chamber 
response is normal then response will be defined as no opacity in the lens. 
• 
Aqueous reaction - flare (0, trace, 1+, 2-3+, 4+). Note if response to aqueous reaction flare 
question is missing but anterior chamber response is normal then response will be defined 
as 0. 
• 
Aqueous reaction - cells (0, trace, 1+, 2+, 3+, 4+). Note if response to aqueous reaction cells 
question is missing but anterior chamber response is normal then response will be defined 
as 0. 
4.3.4. 
Posterior Segment Examination 
The posterior segment examination data is collected on the dilated binocular indirect 
ophthalmoscopy eCRF page. The posterior segment examination is performed throughout the 
study for the study eye and at screening and end of study only for the fellow eye. The following 
endpoints will be investigated for the study eye and fellow eye (screening and end of study only): 
• 
Posterior segment abnormalities (none, mild, moderate, severe) 
• 
Presence of posterior vitreous detachment 
• 
Presence of retinal haemorrhage/detachment 
• 
Vitreal haemorrhage density (none, 1+, 2+, 3+, 4+) 
• 
Vitreous cells evaluation (none, 1+, 2+, 3+, 4+) 
4.3.5. 
LOCS III Lens  
If an abnormal lens finding is noted during the anterior segment (slit lamp) examination, at any 
visit, then the finding should be further characterized with LOCS III. All subsequent visits for that 
subject will include LOCS III. LOCS III is used to grade the severity of age-related cataracts. LOCS III 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
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grading will not be assessed for pseudophakic and aphakic subjects as they do not have opacity. 
For the subset of subjects having this additional ophthalmology assessment, the endpoints are: 
• 
[NO] nuclear opalescence (range 0.1 to 6.9) 
• 
[NC] nuclear color (range 0.1 to 6.9) 
• 
[C] cortical cataract (range 0.1 to 5.9) 
• 
[P] posterior subscapular cataract (range 0.1 to 5.9) 
For all endpoints a value of 0.1 represents a completely clear or colourless lens.  Baseline will be 
taken as the last available non-missing assessment prior to first study drug administration. For 
subjects who do not have a baseline measurement for LOCS III but have a baseline anterior segment 
assessment which confirms no opacity in the lens, then it will be assumed that there were no 
abnormal lens findings at baseline and a value of 0.1 will be assigned to each of the endpoints. If 
the baseline anterior segment assessment does not confirm opacity of the lens or is missing then 
the baseline for the LOCS III endpoints will be taken as missing. 
The change from baseline in each of the endpoints will be assessed. 
4.3.6. 
Other Safety Endpoints 
Safety will also be assessed through vital signs, laboratory safety data and antigenicity data. 
Changes from baseline will be calculated taking baseline as the last measurement prior to the first 
injection. 
4.4. 
PHARMACOKINETIC ENDPOINTS 
Plasma APL-2 concentrations will be determined from multiple samples taken during the course of 
the study - screening, and at each visit from Day 7 to termination (Day 540). 
Cmax should occur at Day 7 (CDay 7). 
4.5. 
PHARMACODYNAMIC ENDPOINTS  
The pharmacodynamic (PD) endpoints include changes from baseline and percentage changes from 
baseline for the complement parameters CH50 and C3.  Baseline will be taken as the last available 
non-missing assessment prior to first study drug administration.  
5. 
ANALYSIS SETS 
5.1. 
SCREENED POPULATION 
The screened population will include all subjects who signed the informed consent form and are 
screened for participation in this study. This population will only be used for the purposes of 


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Date: 29 January 2018 
POT-CP121614                                                                         
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describing the subject disposition and for listing the data. 
5.2. 
RANDOMIZED POPULATION 
The randomised population will include all randomized subjects. This population will only be used 
for the purposes of describing the subject disposition. 
5.3. 
SAFETY POPULATION  
The safety population will include all subjects randomized who receive at least one injection of 
study medication. The safety population summary groups will be based on the actual treatment 
received for the whole duration of the study. The grouping rule for subjects who receive study 
medication from the incorrect injection during the study will be decided on a case by case basis 
before database lock.  This population will be used for all safety analyses. 
5.4. 
INTENT TO TREAT (ITT) POPULATION 
The ITT population will include all subjects randomized who receive at least one injection of study 
medication. Subjects will be included in their randomized treatment group even if they receive the 
wrong study medication. 
5.5. 
MODIFIED INTENT TO TREAT (MITT) POPULATION 
The MITT population will include all subjects randomized who receive at least one injection of study 
medication and have at least one visit at or after Month 2 where primary efficacy data is collected. 
Month 2 is the first visit on-treatment where lesion area is measured. Subjects will be included in 
their randomized treatment group even if they receive the wrong study medication. This population 
will be used for the primary efficacy analysis and other analyses for efficacy and exploratory 
endpoints. 
If the MITT and the ITT do not differ then only the ITT will be used.  If there are minimal differences 
between these 2 populations then a decision will be made prior to database lock on whether to 
only use one of these populations for reporting. 
5.6. 
PER PROTOCOL (PP) POPULATION  
The PP population will include all subjects in the MITT population who have not violated any 
inclusion or exclusion criteria and/or deviated from the protocol, in a way that could influence their 
efficacy assessment. Subjects will be excluded if they: 
• 
Received less than 75% of their expected injections prior to Month 12.  For subjects 
receiving monthly injections this will be less than 9 injections and for subjects receiving 
injections EOM this will be less than 4 injections. 


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Date: 29 January 2018 
POT-CP121614                                                                         
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• 
Receive the incorrect study medication throughout the study 
Subjects will be included in their ‘as treated’ treatment group. Note that this will be the same as 
the randomized treatment because receiving the wrong study medication is a major deviation. 
Data listings, including protocol deviations (Section 5.9), will be provided to identify subjects to be 
excluded from the PP population prior to database lock. Precise reasons for excluding subjects will 
be documented prior to locking the database. 
5.7. 
PHARMACOKINETIC (PK) POPULATION  
The PK population will include all subjects in the safety population who have at least one 
quantifiable concentration of APL-2 (even if <LLOQ). 
5.8. 
PHARMACODYNAMIC (PD) POPULATION  
The PD population will include all subjects in the safety population who have at least one 
quantifiable post dose PD parameter. 
5.9. 
PROTOCOL DEVIATIONS 
All protocol deviations will be reviewed and documented before database lock. Protocol deviations 
will be recorded by the site staff, study monitors and medical monitor reviewers.  They may also be 
identified through programmable checks of the data. 
Key protocol deviations include: 
• 
Violations of inclusion and exclusion criteria. This includes unknown violations at enrolment 
and on-study violations, like taking a prohibited medication  
• 
Receive the incorrect study medication 
Protocol deviations will be categorized as either major or minor prior to database lock. All protocol 
deviations will be listed. 
5.10. 
DATA REVIEW FOR ANALYSIS POPULATIONS 
After all the data has been entered and verified in the database, a review will be performed to 
define the analysis populations.  The review will also check the quality of the data, identify outliers 
and make decisions on how to deal with problems in any data (e.g. missing values, withdrawals, 
protocol deviations). After the pre-analysis review, resolution of all issues and documentation of all 
decisions the database will be locked. 


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6. 
GENERAL ASPECTS FOR STATISTICAL ANALYSIS 
6.1. 
GENERAL METHODS 
All statistical tests will be 2-sided at the 0.1 level of significance. To understand the clinical 
significance of the estimated treatment effects and to aid interpretation of the formal hypothesis 
testing 2-sided 95% CI will also be provided. There will not be any adjustments for multiple 
comparisons.  
For all independent ophthalmic assessments (performed by DARC laboratory), if assessments by 
only two independent readers are available, then the mean of the 2 readings will be used in the 
calculation of summary statistics.  If assessments by three independent readers are available, then 
the median of the three readings will be used for the summary calculations. 
Continuous variables will be summarized using the number of non-missing observations (n), mean, 
standard deviation (SD), median, minimum, and maximum. Geometric mean and coefficient of 
variation (CV) will be included for PK parameters, where appropriate. Categorical variables will be 
summarized using frequencies and percentages.  Unless stated otherwise, for all percentages, the 
number of subjects in the analysis population for the treatment group will be the denominator. 
Unless otherwise specified, the estimated mean and median for a set of values should be printed 
out to 1 more decimal place than the original values, and standard deviations should be printed out 
to 2 more decimal places than the original values. The minimum and maximum should report the 
same number of decimal places as the original values. Percentages will be displayed with 1 decimal 
place; except percentages will not be presented when the count is zero and 100% will be presented 
as an integer. 
Unless stated otherwise, baseline will be taken as the last available non-missing assessment prior 
to first study drug administration. 
Subjects can discontinue treatment but remain in the study for follow-up.  All assessments will be 
included in summary tables or analyses unless stated otherwise.  
For all summary tables, data will be presented by treatment group and by pooled sham and pooled 
APL-2.   For summaries by-visit pooled sham and pooled APL-2 will only be presented for the bi-
monthly visits. The treatment group labels for summary tables will be: 
• 
APL-2 Monthly 
• 
APL-2 EOM 
• 
APL-2 Pooled 
• 
Sham Monthly 
• 
Sham EOM 
• 
Sham Pooled 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
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In general, all summary tables will display the treatment groups in the above order except for cases 
where it’s more convenient for comparison purposes to layout the Sham Pooled group with both 
AMP-2 Monthly and APL2- EOM groups on the same page.  In by-visit summary tables the baseline 
will be summarized using all available data, but also for each visit using only the baseline data from 
subjects with available data at the visit. 
All data will be listed.  Data listings will be presented by treatment group. Data listings will present 
study days in addition to dates, where study day is derived as (assessment date – first day of dosing) 
+1. The first day of dosing will be identified as Study Day 1. The analysis visit (derived from visit 
windowing – refer to Section 6.3) alongside the actual visit and the time since last dose will also be 
included in relevant listings. 
All statistical analyses will be performed using SAS® (Version 9.4 or higher, SAS Institute Inc., Cary, 
NC, USA). 
6.2. 
MISSING DATA 
All possible efforts will be made to minimize missing data. As missing data may potentially bias the 
outcome of the statistical analyses and the subsequent estimation of the magnitude of the 
treatment effect, different strategies will be applied to provide a balanced assessment of treatment 
efficacy. 
Where specified screen values or pre-dose unscheduled measurements may be used as a baseline 
value in the event of missing Day 1 measurements. 
Handling of missing dates/times for the start/stop of medications and adverse events are detailed 
in Sections 7.5 and 11.1 respectively. 
The original data will always be presented in the listings. 
6.2.1. 
Efficacy Data 
Missing data may result from a subject discontinuing, a particular assessment missed at a visit or a 
complete visit missed. For the primary analysis sensitivity analyses will be conducted to assess the 
influence of missing data.  These include: 
• 
Last observation carried forward (LOCF). The LOCF approach will replace missing Month 
12 (or Month 18) data with the last observation recorded. 
• 
Linear mixed effects model for repeated measures (MMRM). The MMRM approach 
assumes data are missing at random and uses a restricted maximum likelihood (REML) 
repeated measures model to analyse available data. 


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Date: 29 January 2018 
POT-CP121614                                                                         
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6.2.2. 
Pharmacokinetic and Pharmacodynamic Data 
APL-2 concentrations reported as below the limit of quantification (BLQ) will be taken as zero for 
linear plots, and equal to the lower limit of quantification (LLOQ) for semi-logarithmic plots.  For 
the computation of descriptive statistics, BLQ will be taken as zero, except for the calculation of the 
geometric mean where the LLOQ will be used. 
If a BLQ value falls between two quantifiable concentrations the value will be set equal to the LLOQ, 
unless its exclusion can be justified (e.g. implausibility given the profile observed and known PK 
properties). 
If a baseline PD value is zero, then the percentage change from baseline will not be calculated. If a 
PD value is BLQ then the value will be set to the LLOQ. Similarly, for the PD plots, a BLQ value will 
be set equal to LLOQ. 
6.3. 
VISIT WINDOWS 
Analysis visits will be derived with windowing for the Day 7 and monthly visits. Screening can be up 
to 2 weeks before start of study treatment. Baseline is defined as the date of randomization. Table 
2 below defines the analysis windows for the visits. If 2 or more treatment visits occur within a 
window, the closest visit to the target day will be used as that analysis visit; if 2 visits are equidistant 
from the scheduled analysis visit day, the later analysis visit will be used. 
Visit windowing will be reviewed prior to reporting and assessments where the actual study day 
does not fall within the protocol visit window for the Day 7 or monthly visits will be identified and 
the allocation reviewed. For the two EOM treatment groups, visits that lie within the window for 
an odd month will not be summarized. 
Table 2: Analysis Windows 
Analysis  
Visit 
Target 
Study Day 
Protocol Visit 
Window (days) 
Analysis Window 
(days) 
 
Screening 
-14 
± 5 
NA 
 
Baseline 
1 
0 
NA 
 
Day 7 
8 
± 2 
2 to 16 
 
Month 1 
31 
± 6 
17 to 46 
 
Month 2 
61 
± 6 
47 to 76 
 
Month 3 
91 
± 6 
77 to 106 
 
Month 4 
121 
± 6 
107 to 136 
 
Month 5 
151 
± 6 
137 to 166 
 
Month 6 
181 
± 6 
167 to 196 
 
Month 7 
211 
± 6 
197 to 226 
 
Month 8 
241 
± 6 
227 to 256 
 
Month 9 
271 
± 6 
257 to 286 
 


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Date: 29 January 2018 
POT-CP121614                                                                         
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Analysis  
Visit 
Target 
Study Day 
Protocol Visit 
Window (days) 
Analysis Window 
(days) 
 
Month 10 
301 
± 6 
287 to 316 
 
Month 11 
331 
± 6 
317 to 346 
 
Month 12 
361 
± 6 
347 to 376 
 
Month 15 
451 
± 14 
412 to 481 
 
Month 18 
541 
± 14 
511 to 571 
 
EOS 
541 
± 14 
Final Assessment 
 
EOS = End of Study 
6.4. 
SUBGROUPS 
The following subgroups will be considered: 
• 
Country: Australia, New Zealand and United States 
• 
Reticular pseudodrusen at baseline: present, absent 
• 
Age group: split into 3 similar sized groups (<75 years, 75-<85 years, ≥85 years) 
• 
LL-VA deficit at baseline: < overall median value, ≥ overall median value 
• 
Fellow-eye CNV at baseline: yes, no 
• 
GA presence at baseline: unilateral, bilateral 
• 
GA lesion size in the study eye: < 10 mm2, ≥ 10 mm2 
• 
Sex: male, female 
7. 
DEMOGRAPHIC, OTHER BASELINE CHARACTERISTICS AND 
MEDICATION 
7.1. 
PATIENT DISPOSITION AND WITHDRAWALS 
For the screened population the number of subjects screened, the number who failed screening 
and the reason for screen failure will be presented.  For the ITT population the following will be 
presented by treatment group and overall: 
• 
Number of subjects randomized 
• 
Number of subjects completed treatment 
• 
Number of subjects withdrawn from treatment and reason for withdrawal 
• 
Number of subjects completed study 
• 
Number of subjects withdrawn from study and reason for withdrawal 
• 
Number of subjects in each analysis population and reason for exclusion from the PP 
population 
The number of subjects randomized, completed treatment, withdrawn from treatment, completed 
study and withdrawn from study at each site will also be summarized. 


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Date: 29 January 2018 
POT-CP121614                                                                         
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A summary of disposition by visit and by treatment group and overall will also be presented for the 
ITT and MITT populations. This disposition will be split by those receiving treatment (i.e. ongoing in 
study at the time of the visit) and those discontinued treatment prior to visit, and will include the 
following: 
• 
Number of subjects ongoing in study at time of visit 
o Number of subjects attended visit 
o Number of subjects receiving injection 
o Number of subjects discontinued treatment prior to visit 
o Number of subjects missed visit 
• 
Number of subjects discontinued study prior to visit 
7.2. 
DEMOGRAPHIC CHARACTERISTICS 
Demography (gender, race, ethnicity, age [years], country) will be summarized for the ITT and MITT 
populations by treatment group and overall.  Age will be summarized using summary statistics for 
continuous variables. Categorical age (<65 years, 65-<75 years, 75-<85 years and ≥85 years), 
gender, race, ethnicity and country will be summarized using summary statistics for categorical 
variables. 
Age = (informed consent date - date of birth + 1)/365.25 truncated to complete years. 
7.3. 
BASELINE CHARACTERISTICS 
Baseline characteristics (GA lesion size (FAF), BCVA, LL-BCVA, drusen size, IOP, LL-VA deficit, GA 
presence in the fellow eye, presence of reticular pseudodrusen, fellow eye CNV presence and study 
eye) will be summarized for the ITT and MITT populations by treatment group and overall.  GA 
lesion size, BCVA, LL-BCVA, drusen size, IOP, LL-VA deficit and presence of reticular pseudodrusen 
will be summarized separately for the study eye and the fellow eye. GA lesion size (measured by 
FAF), BCVA, LL-BCVA and study eye IOP will be summarized using summary statistics for continuous 
variables. Drusen size (none, small, intermediate or large), LL-VA deficit (< overall median value, ≥ 
overall median value), GA presence in the fellow eye (yes, no), presence of reticular pseudodrusen, 
fellow eye CNV presence and study eye (OD, OS) will be summarized using summary statistics for 
categorical variables. 
7.4. 
MEDICAL HISTORY AND CONCOMITANT DISEASES 
Medical history will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) 
Version available. Summaries will be presented for the ITT and MITT populations by System Organ 
Class (SOC) and Preferred Term (PT) with counts and percentages by treatment group and overall. 
Each subject will be counted only once in each SOC or SOC/PT summary. 
All ocular history, will be summarized for the ITT and MITT populations by System Organ Class (SOC) 


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Date: 29 January 2018 
POT-CP121614                                                                         
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and Preferred Term (PT) with counts and percentages by treatment group and overall. The 
summaries will be produced separately for the study eye and the fellow eye. Any ocular condition 
associated with both eyes will be included in both summaries. 
7.5. 
PRIOR AND CONCOMITANT MEDICATIONS 
Prior and concomitant medications will be coded using the latest WHO Drug Dictionary version 
available. Medication will be presented for the safety population by ATC level 2 (therapeutic main 
group) and ATC level 5 (standardized medication name) with counts and percentages by treatment 
group and overall.  A subject who took more than one medication will be counted only once if these 
medications belong to the same extended ATC classification. In addition, prior and concomitant 
medications used in study eye will be summarized. Similar summaries will be provided for the 
medications used in the fellow eye. 
Prior medications will be defined as those medications started prior to the administration of study 
drug on Day 1. Concomitant medications will be defined as those medications taken following the 
first administration of study drug on Day 1. Hence medications started before study dosing, but 
continuing after are considered as both prior and concomitant medications. The listing of 
medications will identify prior and concomitant medications. 
If either the start or stop date of medication is missing, the worst or most conservative case will be 
considered when assigning medications to categories. So for a missing start date (where stop date 
is after date of first dose or missing) the date will be imputed as the date of first dose; for a missing 
stop date the date will be imputed as the last study date.  If a partial date is recorded, the following 
convention will be used to assign the medication: 
• 
If a partial date is missing a start day and the month/year is the same as first dose date then 
use first dose date, else ‘01’ will be used for the day; if a start date is missing a month and 
the year is the same as first dose date then use first dose date, else January will be used for 
the start month. 
• 
If a partial date is missing a stop day and month/year is same as last study date then use 
last study date, else last day of the given month will be used for the stop day; if a stop date 
is missing a month and the year is the same as last study date then use last study date, else 
December will be used for the stop month. 
7.6. 
EXTENT OF EXPOSURE 
The number of injections, number of missed injections and duration of treatment will be 
summarized by treatment group for the ITT and MITT populations using frequency counts and 
percentages. The number of subjects receiving injections at each of the Months (1-12) will also be 
summarized by treatment group using frequency counts and percentages. As treatment is 
administered in the clinic there is no need to assess compliance. 


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Date: 29 January 2018 
POT-CP121614                                                                         
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Duration of treatment (days) = date of last injection – date of first injection +1 
The number of missed injections is defined as the scheduled injections missed up to discontinuation 
of study treatment. 
Study drug administration will be listed by treatment group.  In addition, a listing of total number 
of injections, duration of treatment, date and day of first and last dose and number of missed 
injections will be provided. 
8. 
EFFICACY 
For the primary 12-month analyses, all efficacy data up to Month 12 will be included.  For the final 
18-month database lock, all by-visit summaries and analyses of change from baseline over time 
that are specified in this section, whenever applicable, will be repeated to include all data up to 
Month 18.  The summary or analysis of data at Month 12 will be repeated for the data at Month 
18. 
8.1. 
PRIMARY EFFICACY ENDPOINT AND ANALYSIS 
The primary endpoint is the change from baseline in square root area for GA lesion at Month 12 as 
measured by FAF.  Baseline will be taken as the last available non-missing assessment prior to first 
study drug administration, this should be the screening assessment for the primary endpoint. 
The change from baseline in square root area for GA lesion at Month 2, 6 and 12 will be analysed 
for the MITT population with a MMRM. The model will include the fixed effects of treatment (3 
groups: AM, AEOM and Sham), baseline square root area for GA lesion, visit (2, 6 and 12 months), 
treatment by visit interaction, visit by baseline interaction and treatment by baseline interaction. 
An unstructured covariance structure will be used to model the within subject error. The Kenward-
Rogers approximation will be used to estimate the denominator degrees of freedom. If the 
treatment by baseline interaction is not significant at the 10% level then this term will be removed 
from the model. If significant at the 10% level results will be presented both including and excluding 
this term and the nature of the interaction will be investigated before deciding on an approach for 
presenting results that include the treatment by baseline interaction. 
All available data will be included in the analysis. The analysis model table will be presented.  The 
treatment comparisons (AM vs Sham, AEOM vs Sham and AM vs AEOM) at Months 2, 6 and 12 will 
also be presented with the estimate, standard error and 95% CI.  If the treatment effect is significant 
at the 10% level then the treatment means will be compared using the least significant difference 
(LSD) method and the p-value presented.  In addition, the estimated mean (i.e. Least-Squares 
mean) change from baseline in square root area for GA lesion with ± SE of mean change, will be 
plotted over time by treatment group. 
The model assumptions will be checked by evaluating the model residuals. A Shapiro-Wilks test will 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
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be performed on the residuals; a p-value > 0.1 will be considered proof of normality. If a Shapiro-
Wilks p-value is ≤ 0.1, the residual plots will be evaluated for symmetry. If the evaluation of 
residuals indicates a problem with the model assumptions, another transformation of the data will 
be considered. 
The change from baseline in square root area for GA lesion will be summarized by treatment group 
and visit for the MITT population using the observed data and replacing missing values with 
predicted values from the model.  Summaries will present the descriptive statistics for baseline, 
absolute values and change from baseline data.  The absolute values for missing data will be derived 
as the predicted change from baseline in square root area for GA lesion plus observed baseline 
value. 
The observed values for the square root area for GA lesion will be summarized by treatment group 
and visit for the MITT population.  Summaries will present the descriptive statistics for baseline, 
absolute values and change from baseline data.  The observed mean change from baseline in square 
root area for GA lesion with ± SE of mean change, will be plotted over time by treatment group. 
8.1.1. 
Sensitivity Analyses of the Primary Endpoint 
The robustness of the primary analysis will be evaluated by repeating the primary analysis with the 
per-protocol population. 
In addition, the following sensitivity analyses will be conducted using the MITT population: 
• 
A MMRM analysis including only data which is within a specific time period of the last 
injection. Month 6 data will be included if a subject was dosed on or after Month 4, and 
Month 12 will be included if a subject was dosed on or after Month 8. All Month 2 data will 
be included, as the criteria to be included in the MITT population requires a subject to have 
had at least one dose of study medication. The primary analysis will be repeated using this 
subset of data. 
• 
An analysis using an LOCF method for handling missing data as specified in Section 6.2.1. 
All available Month 12 data will be included and missing data will be replaced using LOCF 
method. An analysis of Covariance (ANCOVA) model will be fitted for the Month 12 change 
from baseline in square root area for GA lesion, that includes baseline as a covariate and 
treatment (3 groups: AM, AEOM and Sham).  
• 
Completer analysis i.e. observed data for those subjects who complete the treatment 
period (for subjects receiving monthly injections this will be 12 injections and for subjects 
receiving EOM injections this will be 6 injections) and have their Month 12 assessment.  The 
analysis model will be the same as for the primary analysis. 
For each approach, a summary over time will be presented. The analysis model table will be 
presented.  The treatment comparisons (AM vs Sham, AEOM vs Sham and AM vs AEOM) will also 
be presented with the estimate, standard error and 95% CI.  If the treatment effect is significant at 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
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the 10% level then the treatment means will be compared using the least significant difference 
(LSD) method and the p-value presented. 
8.1.2. 
Additional Analyses of the Primary Endpoint 
The completer cases at Month 6 i.e. observed data for those subjects who complete 6 months of 
treatment (for subjects receiving monthly injections this will be 6 injections and for subjects 
receiving EOM injections this will be 3 injections) and have their Month 6 assessment; will be 
analysed using the same model as the primary analysis. This analysis will be repeated for the 
completer cases at Month 18 i.e. subjects who complete the treatment period (for subjects 
receiving monthly injections this will be 13 injections and for subjects receiving EOM injections this 
will be 7 injections) and have their Month 18 assessment. 
The untransformed change from baseline in area for GA lesion at Month 2, 6 and 12 will be analysed 
for the MITT population using the same model as the primary analysis. The estimated mean change 
from baseline in area for GA lesion with ± SE of mean change, will also be plotted over time by 
treatment group. 
Additional summaries and analyses will be performed for the subgroups detailed in Section 6.4. 
These analyses will be based on the MITT population and will use the same analysis approach as 
specified in Section 8.1, however the treatment by baseline interaction will only be investigated if 
it is significant for the primary analysis. 
In addition, the observed mean change from baseline in square root area for GA lesion ± SE of mean 
change, will be plotted over time by treatment group and reticular pseudodrusen at baseline 
(present/absent) on the same plot. 
8.1.3. 
GA Lesion Growth Rate between Timepoints of Interest 
Upon reviewing the 12-month data of the study for the primary analysis, a different growth rate 
was observed from Month 6 to Month 12 as compared from Baseline to Month 6 for the active 
group. To assess the growth rate between any two timepoints of interest (Months 6, 12 and 18), 
the change in GA lesion from Month 6 to Month 12, Month 12 to Month 18, and Month 6 toMonth 
18 will be summarized.  One-way ANOVA will be used to compare the treatment effect on the GA 
lesion growth between the given timepoints.  The pairwise treatment group comparisons will be 
done based on the least significant different (LSD) t-test to adjust the multiplicity.  
 


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POT-CP121614                                                                         
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8.2. 
SECONDARY AND EXPLORATORY EFFICACY ENDPOINTS AND 
ANALYSIS 
8.2.1. 
Best-Corrected Visual Acuity (BCVA) 
The change from baseline in BCVA score over time to Month 12 will be analysed in the same way 
as the primary endpoint for the MITT population.  The model will include the fixed effects of 
treatment (3 groups: AM, AEOM and Sham), baseline BCVA score, visit (Day 7, Months 2, 4, 6, 8, 10 
and 12), treatment by visit interaction, visit by baseline interaction and treatment by baseline 
interaction. An unstructured covariance structure will be used to model the within subject error. 
The Kenward-Rogers approximation will be used to estimate the denominator degrees of freedom. 
If the treatment by baseline interaction is not significant at the 10% level then this term will be 
removed from the model. If significant at the 10% level results will be presented both including and 
excluding this term and the nature of the interaction will be investigated before deciding on an 
approach for presenting results including the treatment by baseline interaction. 
The analysis model table will be presented.  The treatment comparisons (AM vs Sham, AEOM vs 
Sham and AM vs AEOM) at Months 6 and 12 will also be presented with the estimate, standard 
error and 95% CI.  If the treatment effect is significant at the 10% level then the treatment means 
will be compared using the least significant difference (LSD) method and the p-value presented. 
The change from baseline in BCVA score will be summarized by treatment group and visit for the 
MITT population using the observed data.  Summaries will present the descriptive statistics for 
baseline, absolute values and change from baseline data.  
The estimated mean change from baseline in BCVA score ± SE of mean change, will be plotted over 
time by treatment group. The plot will be repeated for the observed mean change from baseline in 
BCVA score ± SE of mean change. 
The categorical changes (improvements of ≥5 to <10, ≥10 to <15 and ≥15, minimal/no change, 
worsening of ≥5 to <10, ≥10 to <15 and ≥15, and missing changes) will be summarized by treatment 
group and visit for the MITT population.  
The Snellen equivalent categorical response will be summarized by treatment group and visit for 
the MITT population. The observed logMAR changes from baseline will also be summarized by 
treatment group and visit for the MITT population. The listing of BCVA data will also include the 
logMAR values. 
The relationship between GA lesion size change from baseline as recorded by FAF and changes from 
baseline in BCVA will also be investigated.  A scatter plot of changes from baseline at Month 12 in 
GA lesion size as measured by FAF versus changes from baseline at Month 12 in BCVA will be 
presented. Treatment groups will be identified on the plot. The Pearson correlation coefficient for 
each treatment group will also be presented. Similar summary and figures will be provided for 


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Date: 29 January 2018 
POT-CP121614                                                                         
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relationship at Month 18.  To assess whether there is a delay in visual acuity decline compared to 
GA growth, the scatter plot of the changes from baseline for GA lesion at Month 6 vs BCVA at Month 
12, and GA lesion at Month 12 vs BCVA at Month 18 will be provided.   
8.2.2. 
Macular Neovascularization (MNV) 
The incidence and exposure adjusted incidence of macular neovascularization (MNV) TEAEs in the 
study eye will be summarized for the MITT population.   
Exposure adjusted incidence (or incidence rate per 100-patient-years) = number of subjects 
experiencing MNV / total subject time at risk (in years) × 100 
Total subject time at risk is the time from first study drug administration date to first MNV event 
date +1 for subjects who experience an event, or time from first study drug administration date to 
last visit date +1 for subjects who do not experience a MNV event.  Total subject time will be 
presented in years with a year = 360 days for the calculation.  
The incidence for the MITT population will be compared between the active treatment groups (APL-
2 Monthly or APL-2 EOM) and sham group using a Fisher’s exact chi-squared test. The analysis will 
be repeated by the subgroup fellow eye CNV at baseline. 
8.2.3. 
Low Luminance Best-Corrected Visual Acuity (LL-BCVA) 
The change from baseline in LL-BCVA score over time to Month 12 will be analysed in the same way 
as the BCVA endpoint (Section 8.2.1) for the MITT population.   
The analysis model table will be presented.  The treatment comparisons (AM vs Sham, AEOM vs 
Sham and AM vs AEOM) at Months 6 and 12 will also be presented with the estimate, standard 
error and 95% CI.  If the treatment effect is significant at the 10% level then the treatment means 
will be compared using the least significant difference (LSD) method and the p-value presented. 
The change from baseline in LL-BCVA score will be summarized by treatment group and visit for the 
MITT population using the observe data.  Summaries will present the descriptive statistics for 
baseline, absolute values and change from baseline data.  
The estimated mean change from baseline in LL-BCVA score with ± SE of mean change, will be 
plotted over time by treatment group. The plot will be repeated for the observed mean change 
from baseline in BCVA score ± SE of mean change. 
The categorical changes (improvements of ≥5 to <10, ≥10 to <15 and ≥15, minimal change, 
worsening of ≥5 to <10, ≥10 to <15 and ≥15, and missing changes) will be summarized by treatment 
group and visit for the MITT population.  
The Snellen equivalent categorical response will be summarized by treatment group and visit for 


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POT-CP121614                                                                         
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the MITT population. The observed logMAR changes from baseline will also be summarized by 
treatment group and visit for the MITT population. The listing of LL-BCVA data will also include the 
logMAR values. 
The relationship between GA lesion size change from baseline as recorded by FAF and changes from 
baseline in LL-BCVA will also be investigated.  A scatter plot of changes from baseline at Month 12 
in GA lesion size as measured by FAF versus changes from baseline at Month 12 in LL-BCVA score 
will be presented. Treatment groups will be identified on the plot. The Pearson correlation 
coefficient for each treatment group will also be presented. Similar summary and figures will be 
provided for relationship at Month 18.   To assess whether there is a delay in LL-BCVA decline 
compared to GA growth, the scatter plot of the changes from baseline for GA lesion at Month 6 vs 
LL-BCVA at Month 12, and GA lesion at Month 12 vs LL-BCVA at Month 18 will be provided.   
8.2.4. 
Low Luminance Visual Acuity (LL-VA) Deficit 
The change from baseline in LL-VA deficit over time to Month 12 will be analysed in the same way 
as the BCVA endpoint (Section 8.2.1) for the MITT population.   
The analysis model table will be presented.  The treatment comparisons (AM vs Sham, AEOM vs 
Sham and AM vs AEOM) at Months 6 and 12 will also be presented with the estimate, standard 
error and 95% CI.  If the treatment effect is significant at the 10% level then the treatment means 
will be compared using the least significant difference (LSD) method and the p-value presented. 
The change from baseline in LL-VA Deficit will be summarized by treatment group and visit for the 
MITT population using the observe data. Summaries will present the descriptive statistics for 
baseline, absolute values and change from baseline data.  
The estimated mean change from baseline in LL-VA deficit with ± SE of mean change, will be plotted 
over time by treatment group. The plot will be repeated for the observed mean change from 
baseline in LL-VA deficit ± SE of mean change. 
8.2.5. 
Foveal Encroachment (Distance of GA Lesion from Fovea) 
The change from baseline in distance of GA lesion from fovea over time to Month 12 will be 
analysed in the same way as the primary endpoint (Section 8.1) for the MITT population.   
The analysis model table will be presented.  The treatment comparisons (AM vs Sham, AEOM vs 
Sham and AM vs AEOM) at Months 2, 6 and 12 will also be presented with the estimate, standard 
error and 95% CI.  If the treatment effect is significant at the 10% level then the treatment means 
will be compared using the least significant difference (LSD) method and the p-value presented. 
The change from baseline in foveal encroachment will be summarized by treatment group and visit 
for the MITT population using the observe data.  Summaries will present the descriptive statistics 


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Date: 29 January 2018 
POT-CP121614                                                                         
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for baseline, absolute values and change from baseline data.  
The observed mean change from baseline in distance of GA lesion from fovea with ± SE of mean 
change, will be plotted over time by treatment group.  
8.2.6. 
Drusen Size 
Study eye drusen size (none, small, intermediate or large) and number of intermediate/large drusen 
collected at baseline and end of study will be summarized by treatment group for the MITT 
population with a shift table relative to baseline. Marginal totals will be included and missing data 
will also be summarized. The end of study visit will be summarized including and excluding subjects 
who discontinued treatment early.   
8.2.7. 
GA Lesion Size Measured by SD-OCT 
The change from baseline in square root area for GA lesion over time to Month 12 as measured by 
SD-OCT will be analysed for the subset of subjects who have data, in the same way as the primary 
endpoint for the MITT population.   
The analysis model table will be presented.  The treatment comparisons (AM vs Sham, AEOM vs 
Sham and AM vs AEOM) at Months 2, 6 and 12 will also be presented with the estimate, standard 
error and 95% CI.  If the treatment effect is significant at the 10% level then the treatment means 
will be compared using the least significant difference (LSD) method and the p-value presented. 
The change from baseline in square root area for GA lesion will be summarized by treatment group 
and visit for the MITT population using the observe data Summaries will present the descriptive 
statistics for baseline, absolute values and change from baseline data.  
8.2.8. 
Genetic Polymorphisms 
Genetic marker analysis will be performed by The Institute of Human Genetics at the University of 
Regensburg. The relationship of the primary endpoint and each gene will be investigated. The 
analysis will be documented in a separate report and included in the CSR as an appendix. 
8.2.9. 
Other Ophthalmology Data 
All other ophthalmology data collected but not discussed in other sections of the SAP will be listed 
by treatment group.  The ophthalmology assessments performed in this study include the following: 
• 
Fundus Autofluorescence Photographs (FAF) 
• 
SD-OCT 
• 
Digital Color Fundus Photographs (DCFP) 
• 
Fundus Fluorescein Angiograms (FFA) 


Apellis Pharmaceuticals, Inc. 
 
Date: 29 January 2018 
POT-CP121614                                                                         
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• 
Infrared Reflectance (IR) 
• 
BCVA and LL-BCVA 
9. 
ANALYSIS OF PHARMACOKINETICS 
9.1. 
CONCENTRATION DATA 
The APL-2 trough concentrations will be evaluated using the PK population. APL-2 trough 
concentrations will be summarized by treatment group at each protocol specified time point using 
descriptive statistics including the interquartile range.  The number of subjects with a BLQ value 
will also be tabulated. 
Linear and log-linear individual trough concentration profile plots against time will be produced for 
each APL-2 treatment group. The actual sampling time will be used on the x-axis. 
Linear and log-linear median trough concentration profile plots against time will be produced by 
treatment group. The nominal sampling time will be used on the x-axis. 
A listing of all trough concentration data will be presented by treatment group.   
9.2. 
PHARAMCOKINETIC DATA  
Cmax should occur at Day 7 (CDay 7), which will be listed and summarized as part of the 
concentration data.  No additional presentations are required.  
10. 
ANALYSIS OF PHARMACODYNAMICS 
The PD parameters (CH50 and C3) will be evaluated using the PD population.  Absolute values, 
changes from baseline and percentage changes from baseline for the PD parameters will be 
summarised by treatment group at each protocol specified time point using descriptive statistics. 
For each PD parameter, the individual absolute values and individual changes from baseline will be 
presented graphically for each treatment group. Actual sampling times will be used for the graphical 
presentation of individual data.  
The mean absolute values, mean changes from baseline and mean percentage changes from 
baseline will also be presented graphically by treatment group. Nominal sampling times will be used 
for the mean plots. 
Individual PD parameters will be listed together with changes from baseline and percentage 
changes from baseline by treatment group.  


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POT-CP121614                                                                         
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11. 
SAFETY 
All safety evaluation will be performed on the safety population. 
11.1. 
ADVERSE EVENTS 
AEs will be summarized separately for those occurred in the study eye, those in the fellow eye, and 
the non-ocular events. 
AEs will be coded using the latest MedDRA version available. 
According to the completion guidelines for this study any AE recorded prior to first dose of study 
drug should be recorded on the medical or ocular history page instead. So, all AEs recorded should 
be treatment emergent AEs (TEAE). However, a check will be made and AEs will be considered 
treatment-emergent unless there is clear indication that the event occurred prior to the first dose 
of study drug.  AEs present prior to study drug administration that increased in severity or 
relationship to study drug after the first dose of study drug and up to 60 days beyond the last dose 
of study drug will be classed as TEAE.  Events with missing or partial dates will be handled such that 
in the absence of contradictory information an AE is treatment emergent. So, for a missing start 
date (where stop date is after first dosing date or missing) the date will be imputed as the first dose 
date; for a missing stop date the date will be imputed as the last study date.  If a partial date is 
recorded, the following convention will be used to assign the AE: 
• 
If a start date is missing the day information and month/year is the same as first dose date 
then use first dose date, else ‘01’ will be used for the day; if a start date is missing the 
month and the year is the same as first dose date then use first dose date, else January will 
be used for the start month. 
• 
If a stop date is missing the day information and month/year is same as last study date then 
use last study date, else last day of the given month will be used for the stop day; if a stop 
date is missing the month and year is the same as last study date then use last study date, 
else December will be used for the stop month. 
Only TEAEs will be included in the summary tables. An overall summary will present the number 
of subjects by treatment group and overall with: 
• 
any TEAE 
• 
any TEAE considered as related to study drug (evaluated by the investigator as Possibly 
Related or Probably Related or not reported) 
• 
any serious TEAE  
• 
any treatment emergent AESI (TEAESI) in either eye  
• 
any TEAESI in study eye 
• 
Maximum severity TEAE of none, mild, moderate, severe, life-threatening, death ; i.e. a 
subject with TEAEs at different intensities will be summarized at the most severe intensity 


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POT-CP121614                                                                         
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• 
any TEAE leading to study drug discontinuation  
• 
any TEAE leading to death 
The table will also include the total number of TEAEs reported and total number of TEAESI reported.  
The total number of unique terms within subjects will also be presented, counting each TEAE only 
once within each subject.  
The number and percentage of subjects with TEAEs will be presented by SOC, PT and by treatment 
group and overall. Subjects with multiple TEAEs within a SOC or SOC/PT combination will be 
counted only once for that SOC or SOC/PT combination. Similar summaries will be presented for 
related TEAEs, TEAEs leading to discontinuation, serious TEAEs and TEAESI in study eye. 
Summaries of TEAEs by maximum severity (mild, moderate, severe, Life-threatening or death) will 
be presented.  This will be repeated for TEAESI in study eye. 
All summaries will be ordered by descending order of total events in the APL-2 pooled group. 
All TEAEs will be listed by treatment group, subject and AE onset date. Separate listings of serious 
AEs, AESI and AEs leading to discontinuation of study drug will also be generated.  For the listing 
of AESI the effected eye (study or fellow) will also be listed. 
11.2. 
INTRA OCULAR PRESSURE (IOP) 
The observed and change from baseline values in IOP over time will be summarized by treatment 
group and protocol specified time points for the safety population.  Summaries will present the 
descriptive statistics for baseline and change from baseline data. The acute change in IOP after each 
injection (i.e., change from pre-injection to post-injection value) will also be summarized at each 
protocol specified time point. 
The number of subjects with IOP ≥30 mmHg post injection will be summarized by treatment group, 
visit and over the whole study. 
11.3. 
ANTERIOR SEGMENT EXAMINATION 
Anterior segment examination endpoints (abnormal reaction to light, active inflammation present 
in cornea, abnormal anterior chamber, any opacity in lens, aqueous reaction flare and aqueous 
reaction cells) will be summarized separately for the study eye and the fellow eye by treatment 
group and protocol specified time points for the MITT population, using summary statistics for 
categorical variables. 
11.4. 
POSTERIOR SEGMENT EXAMINATION 
Posterior segment examination endpoints (posterior segment abnormalities, presence of posterior 
vitreous detachment, presence of retinal hemorrhage/detachment, vitreal hemorrhage density and 
vitreous cells evaluation) will be summarized separately for the study eye and the fellow eye by 


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treatment group and protocol specified time points for the MITT population, using summary 
statistics for categorical variables. 
All other ophthalmology data collected based on Slit Lamp and Dilated Binocular Indirect 
Ophthalmoscopy examinations but not discussed in other sections of the SAP will be listed by 
treatment group. 
11.5. 
LOCS III LENS 
The observed and change from baseline values for each of the 4 endpoints (nuclear opalescence, 
nuclear color, cortical cataract and posterior subscapular cataract) will be summarized by 
treatment group and protocol specified time points, for those subjects with LOCS III performed 
during the study. The denominator for this summary will be the subset of phakic subjects who have 
a LOCS III assessment performed at any time during the study. The number of pseudophakic and 
aphakic subjects will also be presented. 
All individual LOCS III data will be listed by treatment group. The listing will include change from 
baseline values. If no baseline value is collected and the baseline anterior segment assessment 
confirms no opacity in the lens then a value of 0.1 will be used for baseline and the change from 
baseline value will be flagged to identify the imputation. 
11.6. 
LABORATORY EVALUATIONS 
Observed and change from baseline clinical laboratory data (hematology, chemistry and urinalysis) 
will be summarized by treatment group and protocol specified time points.  Urinalysis categorical 
data will also be summarized by treatment group and protocol specified time points. Descriptive 
statistics will be used for continuous data and frequency counts and percentages for categorical 
data. A shift table from baseline, by treatment group and protocol specified time points, of normal, 
abnormal low, abnormal high and missing records will also be summarised for hematology and 
chemistry data with marginal totals using frequency counts and percentages. 
All individual laboratory results will be listed by treatment group. The listing will include change 
from baseline values and values outside the laboratory reference range will be flagged. 
11.7. 
ANTIGENICITY DATA 
Summaries of antigenicity data (titre, specificity and immuno-reactivity) by treatment group and 
protocol specified time point will be presented.  Descriptive statistics will be used for specificity 
data and frequency counts and percentages for titre (< 5 or 5) and immuno-reactivity (non-reactive 
or reactive) data. 
Antigenicity data will be listed by treatment group. 


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Date: 29 January 2018 
POT-CP121614                                                                         
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11.8. 
VITAL SIGNS 
Observed and change from baseline values will be summarized for all vital signs data (blood 
pressure, heart rate, respiratory rate and temperature) by treatment group and protocol specified 
time points using descriptive statistics. 
Vital signs data will be listed by treatment group. 
12. 
INTERIM ANALYSES  
A Month 12 cut of the data will be analysed and reported in the CSR. When all subjects have 
completed (or discontinued) the 12 Month assessment visit the data collected up to and including 
these study visits will be cleaned and reported. The exception to this will be SAEs and AESI where 
all available events up to the last subjects Month 12 visit date will be included in the report. Any 
changes to the data reported in this Month 12 cut will be fully auditable and discussed in the 
addendum to CSR that will be generated on the final 18-month study data. 
An external, independent Safety Monitoring Committee (SMC) will review cumulative unmasked 
safety data and will have the responsibility to conduct a thorough safety assessment after the first 
20 subjects have completed the Day 7, Month 2 and Month 6 visits. A key responsibility of the SMC 
will be to make a recommendation whether to continue, modify or stop the study based upon an 
evaluation of emerging safety data, in particular AESI. Additional regular or ad-hoc safety reviews 
will be scheduled as recommended by the SMC. 
13. 
CHANGE FROM ANALYSIS PLANNED IN PROTOCOL 
 The changes from the analyses specified in the protocol are: 
1. The definition of the PP population has been updated to exclude any subject who has 
violated any inclusion or exclusion criteria and/or deviated from the protocol, in a way that 
could influence their efficacy assessment. The protocol refers to the PP as all randomized 
subjects who return for 12 month visit which is simply a completer’s analysis which is 
covered in the sensitivity analyses of the primary endpoint. 
2. The primary analysis specified in the protocol does not take account of baseline in the 
model, however as a precaution baseline has been included in the model.  If there is no 
relationship with baseline then only one degree of freedom is lost by including this term in 
the model.   
3. The protocol specified the use of ANOVA on the data at Month 12 with missing data 
handled by the LOCF or by  a non-precise regression method of imputation when imbalance 
drop-out rates occur across treatment groups.  An MMRM approach, which directly utilizes 


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POT-CP121614                                                                         
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all available data in the model, has been specified in the SAP to account for missing data 
and this will be regarded as the primary analysis. 
4. The pharmacokinetic endpoints of AUC, Cmax, Tmax and t1/2 were specified in the protocol; 
however since only trough concentrations were collected throughout the study it is only 
possible to assess Cmax.  Cmax should occur at Day 7 so the concentration on Day 7 will be 
used (CDay 7). 
5. The protocol specified a standard deviation of annual square root area growth of 
0.21mm/year for the sample size calculations.  However in the power analysis (protocol 
Section 11.3.3) a value of 0.2 was used for the standard deviation. 
6. The protocol refers to the first day of dosing as Day 0 (Visit 2). For reporting purposes CDISC 
standards will be used and therefore it is necessary to refer to the first day of dosing as Day 
1. Consequently throughout the SAP Day 1 is referred to as the first day of dosing. 
 
 


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Date: 29 January 2018 
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14. 
REFERENCES 
1. Yehoshua Z, de Amorim Garcia Filho CA, Nunes RP, et al. Systemic complement inhibition with 
eculizumab for geographic atrophy in age-related macular degeneration: the COMPLETE study. 
Ophthalmology. 2014;121(3):693-701. 
2. Yehoshua Z, Rosenfeld PJ, Gregori G, et al. Progression of geographic atrophy in agerelated 
macular degeneration imaged with spectral domain optical coherence tomography. 
Ophthalmology. 2011;118(4):679-686. 
3. Holz FG, Bindewald-Wittich A, Fleckenstein M, et al. Progression of geographic atrophy and 
impact of fundus autofluorescence patterns in age-related macular degeneration.  American 
journal of ophthalmology. 2007;143(3):463-472. 
4. Rein DB, Wittenborn JS, Zhang X, et al. Forecasting age-related macular degeneration through 
the year 2050: the potential impact of new treatments. Archives of ophthalmology. 
2009;127(4):533-540.