MAGNOLIA: Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema Associated With Non-Infectious Uveitis
Conditions: Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis
Sponsor: Clearside Biomedical, Inc.

Compound Name: 
CLS-TA, triamcinolone acetonide injectable suspension 
Protocol Number: 
CLS1001-303 
IND Number: 
115683 
NCT Number:  
NCT02952001 
Protocol Title 
MAGNOLIA: Multi-center, Non-Interventional Extension 
Study of the Safety and Efficacy of CLS-TA for the 
Treatment of Macular Edema associated with Non-
infectious Uveitis 
Sponsor: 
Clearside Biomedical, Inc. 
900 North Point Parkway, Suite 200 
Alpharetta, GA 30005 
Issue Date: 
Protocol Amendment 1: 
13 October 2016 
14 December 2016 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 2 of 36 
CONFIDENTIAL 
 
 
INVESTIGATOR’S AGREEMENT 
 
I have received and read the Investigator’s Brochure for CLS-TA.  I have read the CLS1001-303 
and agree to conduct the study as outlined.  I agree to maintain the confidentiality of all 
information received or developed in connection with this protocol.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Investigator 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Investigator 
 
 
 
 
 
 
 
 
Date of Signature 

CLS-TA, triamcinolone acetonide injectable suspension
   Clearside Biomedical, Inc 
CLS1001-303 
Clinical Protocol 
Version 2.0 
14 December 2016 
Page 3 of 36 
CONFIDENTIAL 
PROCEDURES IN CASE OF EMERGENCY 
Table 1: 
Emergency Contact Information 
Role in Study 
Name 
Telephone Number 
Clinical Leader, Sponsor 
Ellie Smith 
Ellie.Smith@clearsidebio.com 
+1 678 448 4717
Medical Monitor 
David Hoelscher, MD 
David.Hoelscher@chiltern.com 
Direct:   +1 324 990 0299 
Mobile: +1 512 694 8829 
Fax:        +1 423 968 3567
Rupali Mokashi, MD 
Rupali.Mokashi@chiltern.com 
Direct:    +11 91 22 4098 2767 
Mobile:   +11 91 96 1934 8439 
Fax:        +11 91 22 4098 2727 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 4 of 36 
CONFIDENTIAL 
 
 
2. 
SYNOPSIS 
Name of Sponsor/Company: 
Clearside Biomedical, Inc. 
Name of Investigational Product: 
Triamcinolone Acetonide (CLS-TA) Injectable Suspension 
Name of Active Ingredient: 
Triamcinolone Acetonide 
Title of Study:  
MAGNOLIA: Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of    
CLS-TA for the Treatment of Macular Edema associated with Non-Infectious Uveitis 
Study center(s): Multi-Center 
Principal Investigator: Multi-Center 
Studied period: 6 Month Duration 
Estimated date first patient enrolled: October 2016 
Estimated date last patient completed: September 2017 
Phase of development:  
Non-interventional study 
Objectives:  
Primary: Demonstrate the maintenance of efficacy of CLS-TA, up to 6 months following 
exit from Parent study, as shown by the need for additional therapy or the increase in 
maintenance therapy, for the symptoms of uveitis.  
Secondary: Determine the maintenance of safety of CLS-TA up to 6 months following exit from 
Parent study, as demonstrated by incidence of adverse events related to Parent study investigational 
product  
Number of patients (planned): approximately 30 
Diagnosis and main criteria for inclusion:  
Participation in CLS1001-301, non-infectious uveitis Phase 3 (Parent) study without additional 
therapy for uveitis 
Investigational product, dosage and mode of administration:  
No investigational product administered in this study 
Reference therapy, dosage and mode of administration: None 
Criteria for evaluation: 
Efficacy: Mean time to additional uveitis therapy or change in maintenance therapy for uveitis 
Safety: Incidence of Adverse Events and serious adverse events grouped by organ system, relatedness 
to Parent study investigational product, and severity 
Statistical methods: All data collected in the study database will be presented in the listings. Listings 
will include change from baseline. Baseline is the Crossover Visit. 
Time to Rescue Therapy will be analyzed using Kaplan-Meier analysis including 95% confidence 
intervals, log rank p-value for difference between treatments, and quartiles. 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 5 of 36 
CONFIDENTIAL 
 
 
3. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES  
TABLE OF CONTENTS 
2. 
SYNOPSIS ...................................................................................................................4 
3. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES .................5 
4. 
LIST OF ABBREVIATIONS.......................................................................................9 
5. 
INTRODUCTION ......................................................................................................10 
5.1 
  Disease Background .................................................................................................10 
5.2 
  Scientific Rationale ...................................................................................................10 
5.3 
  Description of Investigational Product .....................................................................10 
5.4 
 Summary of Clinical Experience ...............................................................................11 
6. 
TRIAL OBJECTIVES AND PURPOSE ....................................................................12 
6.1. 
Primary Objective .......................................................................................................12 
6.2. 
Secondary Objectives .................................................................................................12 
7. 
INVESTIGATIONAL PLAN .....................................................................................13 
7.1. 
Overall Study Design ..................................................................................................13 
7.2. 
Number of Subjects ....................................................................................................13 
7.3. 
Treatment Assignment ................................................................................................13 
7.4. 
Criteria for Study Termination ...................................................................................13 
8. 
SELECTION AND WITHDRAWAL OF SUBJECTS ..............................................14 
8.1. 
Subject Inclusion Criteria ...........................................................................................14 
8.2. 
Subject Exclusion Criteria ..........................................................................................14 
8.3. 
Subject Withdrawal Criteria .......................................................................................14 
9. 
TREATMENT OF SUBJECTS ..................................................................................15 
9.1. 
Description of Study Drug ..........................................................................................15 
9.1.1. 
Study Eye Determination ............................................................................................15 
9.1.2. 
Treatment of the Fellow Eye (Non-Study Eye) ..........................................................15 
9.2. 
Concomitant Medications ...........................................................................................15 
9.2.1. 
Medications for treatment of uveitis ...........................................................................15 
9.2.2. 
Additional Treatment ..................................................................................................16 
9.3. 
Treatment Compliance ................................................................................................16 
9.4. 
Randomization and Blinding ......................................................................................16 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 6 of 36 
CONFIDENTIAL 
 
 
10. 
STUDY DRUG MATERIALS AND MANAGEMENT ...........................................17 
11. 
ASSESSMENT OF EFFICACY ................................................................................18 
11.1. 
Best Corrected Visual Acuity (BCVA) ......................................................................18 
11.2. 
Central Subfield Thickness as Measured by SD-OCT ...............................................18 
12. 
ASSESSMENT OF SAFETY .....................................................................................19 
12.1. 
Safety Parameters .......................................................................................................19 
12.1.1. 
Intraocular Pressure ....................................................................................................19 
12.1.2. 
Slit-Lamp Biomicroscopy ...........................................................................................19 
12.1.2.1. 
Cataract Lens Grading ................................................................................................19 
12.1.2.2. 
Anterior Chamber Cells ..............................................................................................19 
12.1.2.3. 
Anterior Chamber Flare ..............................................................................................20 
12.1.3. 
Dilated Ophthalmoscopy ............................................................................................20 
12.1.3.1. 
Vitreous Haze .............................................................................................................20 
12.2. 
Adverse and Serious Adverse Events .........................................................................21 
12.2.1. 
Definition of Adverse Events .....................................................................................21 
12.2.1.1. 
Adverse Event (AE) ....................................................................................................21 
12.2.1.2. 
Serious Adverse Event (SAE) ....................................................................................21 
12.3. 
Relationship to Study Drug ........................................................................................22 
12.4. 
Recording Adverse Events .........................................................................................22 
12.5. 
Reporting Serious Adverse Events .............................................................................23 
12.5.1. 
Transmission of SAE Reports ....................................................................................23 
12.5.2. 
Regulatory Reporting Requirements for SAEs ...........................................................24 
13. 
STATISTICS ..............................................................................................................25 
13.1. 
Randomization ............................................................................................................25 
13.2. 
Determination of Sample Size and Level of Significance ..........................................25 
13.3. 
Subject Disposition, Demographic and Baseline Characteristics ...............................25 
13.4. 
Analysis Population ....................................................................................................25 
13.4.1. 
Safety Population ........................................................................................................25 
13.4.2. 
Intent-to-Treat Population ..........................................................................................25 
13.5. 
Analysis Methods .......................................................................................................25 
13.5.1. 
Primary Efficacy Endpoint .........................................................................................25 
13.5.2. 
Primary Efficacy Analysis ..........................................................................................25 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 7 of 36 
CONFIDENTIAL 
 
 
13.5.3. 
Safety Endpoint ..........................................................................................................26 
13.5.4. 
Safety Analysis ...........................................................................................................26 
13.5.4.1. 
Intraocular Pressure ....................................................................................................26 
13.5.4.2. 
Cataract Lens Grading ................................................................................................26 
13.5.4.3. 
Slit-Lamp Biomicroscopy ...........................................................................................26 
13.5.4.4. 
Dilated Indirect Ophthalmoscopy ...............................................................................26 
13.5.4.5. 
Adverse Events ...........................................................................................................26 
13.5.4.6. 
Prior and Concomitant Medications ...........................................................................27 
13.5.5. 
Interim Analysis ..........................................................................................................27 
13.5.6. 
Extent of Exposure .....................................................................................................27 
13.5.7. 
Procedure for Accounting for Missing, Unused, or Spurious Data ............................27 
13.5.8. 
Multiplicity .................................................................................................................27 
13.5.9. 
Procedure for Reporting Deviations from the Statistical Analysis Plan .....................27 
14. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS.........................................28 
14.1. 
Study Monitoring ........................................................................................................28 
14.2. 
Audits and Inspections ................................................................................................28 
14.3. 
Institutional Review Board (IRB) ...............................................................................29 
15. 
QUALITY CONTROL AND QUALITY ASSURANCE .........................................30 
16. 
ETHICS ......................................................................................................................31 
16.1. 
Ethics Review .............................................................................................................31 
16.2. 
Ethical Conduct of the Study ......................................................................................31 
16.3. 
Written Informed Consent ..........................................................................................31 
17. 
DATA HANDLING AND RECORD KEEPING ......................................................32 
17.1. 
Inspection of Records .................................................................................................32 
17.2. 
Retention of Records ..................................................................................................32 
18. 
PUBLICATION POLICY ..........................................................................................33 
19. 
LIST OF REFERENCES ............................................................................................34 
20. 
APPENDICES ............................................................................................................35 
20.1. 
Appendix A: Schedule of Assessments ......................................................................35 
20.2. 
Appendix B: SUMMARY OF CHANGES FOR AMENDMENTS ..........................36 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 8 of 36 
CONFIDENTIAL 
 
 
LIST OF TABLES 
Table 1: 
Emergency Contact Information ...................................................................................3 
Table 2: 
Abbreviations and Specialist Terms .............................................................................9 
 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 9 of 36 
CONFIDENTIAL 
 
 
4. 
LIST OF ABBREVIATIONS  
The following abbreviations and specialist terms are used in this study protocol. 
Table 2: 
Abbreviations and Specialist Terms  
Abbreviation or Specialist Term 
Explanation 
AE  
Adverse Event 
BCVA 
Best Corrected Visual Acuity 
CRF 
Case Report Form 
CST 
Central Subfield Thickness 
ETDRS 
Early Treatment of Diabetic Retinopathy Study 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonization  
IEC 
Institutional Ethics Committee 
IOP 
Intraocular Pressure 
IRB 
Institutional Review Board 
IND 
Investigational New Drug  
ITT 
Intent-to-Treat 
IVT 
Intravitreal 
MedDRA 
Medical Dictionary for Regulatory Activities 
NSAID 
Non-Steroidal Anti-Inflammatory Drug 
OCT 
Optical Coherence Tomography 
PP 
Per Protocol 
SAE 
Serious Adverse Event 
SCS 
Suprachoroidal Space 
SD-OCT 
Spectral-Domain Optical Coherence Tomography 
TA 
Triamcinolone Acetonide 
VEGF 
Vascular Endothelial Growth Factor 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 10 of 36 
CONFIDENTIAL 
 
 
5. 
INTRODUCTION 
5.1 
 
Disease Background  
Uveitis is the fifth most common cause of visual loss in the developed world (Goldstein 2009; 
Wood 2011; Miserocchi 2013). Significant vision loss can occur in up to 35% of children and 
adults, and uveitis accounts for 5% - 20% of legal blindness in both the United States and 
Europe, and perhaps as much as 25% of blindness in the developing world (Rothova 1996; 
Bodaghi 2001). 
There are a number of causes associated with this vision loss including cataract formation or 
progression, chorioretinal scarring, retinal detachment, and secondary glaucoma, but the 
dominant cause of vision loss within uveitis comes from chronic macular edema accounting for 
about one third of visual impairment or blindness (Wood, 2011; Dick, 1994; Karim, 2013). 
Approximately 30% of all uveitis patients and up to 60% of intermediate- and pan-uveitis 
patients experience macular edema (Lardenoye, 2006). 
 
5.2 
 
Scientific Rationale 
All subjects entering this trial will have received either CLS-TA or sham procedure from the 
Parent study, CLS1001-301, as masked investigational product. The objective of the Parent study 
is to evaluate the safety and efficacy of suprachoroidally administered CLS-TA for the treatment 
of macular edema associated with non-infectious uveitis. Two doses or CLS-TA or a sham 
procedure will be performed in the Parent study on each subject enrolled at Day 0 and Month 3 
visits and the primary endpoint will be evaluated 6 months following the enrollment. 
In addition to providing a robust efficacy and improved safety profile over currently used 
corticosteroid delivery methods, suprachoroidal administration of precisely delivered local 
corticosteroid therapy may provide a longer cessation of uveitis symptoms and reduced steroid 
sensitivity. This potential benefit will be evaluated in this extension study of non-infectious 
uveitis patients who participated in the Parent study and who have not received additional 
therapy for uveitis. 
 
5.3 
 
Description of Investigational Product 
All subjects entering this trial will have received either CLS-TA or sham procedure from the 
Parent study, CLS1001-301, as masked investigational product. There will be no investigational 
product in this study.  
Additional information regarding CLS-TA is available in the Investigator’s Brochure. 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 11 of 36 
CONFIDENTIAL 
 
 
5.4 
Summary of Clinical Experience  
TA has been safely and effectively used in human ocular therapeutics to treat ocular conditions 
involving inflammation for over 50 years. The initial recommended dose of the TA formulation 
(Triesence®) approved by the FDA for ocular indications is 4 mg in 100 µL.  
 
Clearside is developing CLS-TA, a proprietary TA formulation for the treatment of non-
infectious uveitis by administration to the SCS. 
The completed clinical study, CLS1001-101, was a Phase 1/2, open-label, safety and tolerability 
study in subjects with intermediate-, posterior-, or pan- non-infectious uveitis. Each subject 
received a single suprachoroidal injection of 4 mg in 100 µL TA (Triesence). Nine (9) of the 11 
subjects in the safety analysis set (82%) completed the 26-week study. All subjects had at least 
one AE, with a total of 37 AEs reported. One serious event (unrelated pulmonary emboli; SAE) 
occurred. No deaths were reported. No significant increases in IOP were reported. The most 
commonly reported AE, eye pain, was reported in 4 subjects.  
The completed clinical study, CLS1001-201, is a Phase 2, randomized, masked safety and 
efficacy study in subjects with macular edema associated with non-infectious uveitis. Twenty-
two subjects were randomized to either a single suprachoroidal injection of CLS-TA, 4 mg in 
100 µL or 0.8 mg in 100 µL. Subjects in the 4.0mg treatment arm were observed to have a mean 
reduction in central subfield of thickness (CST) of 164 microns (p=0.002) when measured from 
baseline at 2 months. No subjects discontinued due to Adverse Event and there were no 
investigator-reported increases in IOP at follow-up visits. 
Additional information regarding clinical experience with TA administered to the SCS, is 
available in the Investigator’s Brochure. 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 12 of 36 
CONFIDENTIAL 
 
 
6. 
TRIAL OBJECTIVES AND PURPOSE 
The purpose of this study is to characterize the continued clinical benefit(s) regarding safety and 
efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide injectable 
suspension, for the treatment of macular edema associated with non-infectious uveitis. This study 
will be a non-interventional extension of the Parent study, CLS1001-301. 
6.1. 
Primary Objective 
Demonstrate the maintenance of efficacy of CLS-TA, up to 6 months following exit from Parent 
study, as shown by the need for additional therapy or the increase in maintenance therapy, for the 
symptoms of uveitis.  
6.2. 
Secondary Objectives 
Determine the maintenance of safety of CLS-TA up to 6 months following exit from Parent 
study, as demonstrated by incidence of adverse events related to Parent study investigational 
product 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 13 of 36 
CONFIDENTIAL 
 
 
7. 
INVESTIGATIONAL PLAN 
7.1. 
Overall Study Design 
This is a non-interventional extension study of up to 6 months for subjects completing the Parent 
study. The Parent study is a Phase 3, multicenter study to assess the safety and efficacy of 4 mg 
of CLS-TA administered via suprachoroidal injection compared to a sham procedure in the 
treatment of subjects with macular edema associated with non-infectious uveitis. 
The study design of the Extension study includes 4 clinic visits over a maximum of 24 weeks.  
Subject eligibility will be established at Visit 1 during the crossover day from the Parent study to 
the extension study (Day 0). Follow-up visits will be conducted every 6 weeks up to 24 weeks 
(Visit 4). At Visit 4, subjects will have a final evaluation conducted 24 weeks following study 
entry (48 weeks from Parent study randomization). Parent study masking will remain in effect 
until the Parent study is unmasked. 
7.2. 
Number of Subjects 
The study population will include approximately 30 adult subjects that successfully complete the 
Parent study without requiring additional therapy to treat symptoms for uveitis as defined by the 
protocol. The expected duration of participation in the study is up to 24 weeks from study entry. 
The complete inclusion and exclusion criteria are presented below in Section 8. 
7.3. 
Treatment Assignment 
This is a non-interventional extension study. There will be no investigational product 
administered in this study.  
7.4. 
Criteria for Study Termination 
The study or parts of the study may be discontinued by the Sponsor, or at the recommendation of 
an Investigator after consultation with Sponsor, at any time.   
If the clinical study is prematurely terminated or suspended, the Sponsor will inform the 
Investigators and the regulatory authorities of the termination/suspension and the reason(s) for 
the termination/suspension. The Investigator should promptly notify the IEC/IRB of the 
termination or suspension and of the reasons. 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 14 of 36 
CONFIDENTIAL 
 
 
8. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
8.1. 
Subject Inclusion Criteria 
Subjects are eligible for participation in this study if s/he meets all of the following criteria: 
1. Enrolled in the Parent study, CLS1001-301, through Visit 8/Month 6 
2. Willing and able to provide written informed consent prior to any study procedures; willing 
to comply with the instructions and attend all scheduled study visits 
8.2. 
Subject Exclusion Criteria 
1. Received additional therapy for the treatment of uveitis or prohibited medication as defined 
in Section 6.2 of the Parent protocol, CLS1001-301  
2. Require additional therapy for the treatment of uveitis or prohibited medication as defined in 
Section 6.2 of the Parent protocol, CLS1001-301 at the time of the Crossover visit 
8.3. 
Subject Withdrawal Criteria 
Subjects may withdraw from the study at any time and for any reason without obligation. 
Subjects may be removed from the study at the Investigator’s discretion or if they require Rescue 
due to disease progression that warrants further treatment.   
If a subject withdraws from the study or if the Investigator removes a subject from the study, the 
Investigator should make every attempt to complete all Visit 4 assessments (Section 20.1. - 
Appendix A). If at any time during the study a subject is considered at immediate risk for a 
vision-threatening event due to study participation, the subject should be treated as soon as 
necessary, with the investigator determining appropriate care or additional therapy (Section 
9.2.2.). 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 15 of 36 
CONFIDENTIAL 
 
 
9. 
TREATMENT OF SUBJECTS 
9.1. 
Description of Study Drug 
No study drug will be administered in the MAGNOLIA study.   
9.1.1. 
Study Eye Determination 
The study eye will remain the same as in the Parent study, CLS1001-301. 
9.1.2. 
Treatment of the Fellow Eye (Non-Study Eye) 
Ocular therapy for the fellow eye is not subject to the requirements of this protocol. Local 
medications are permitted for the fellow eye during the course of this trial. Systemic therapy for 
diseases of the fellow eye is subject to the list of medications below and will be considered 
additional therapy for the study eye. Medications used in the fellow eye will be recorded in the 
subject’s medical chart and the case report form (CRF).   
 
9.2. 
Concomitant Medications 
9.2.1. 
Medications for treatment of uveitis 
If additional therapy is necessary to treat uveitis in the study eye and normal standard of care 
requires these medications, they will be recorded in the subject’s case report form and should 
follow the guidelines presented for rescue criteria. The list of medications provided below is not 
intended to be comprehensive, but rather to help guide the Investigator’s medical judgment. If 
any of these medications are used during the study, the subject will be considered to have 
received additional therapy for uveitis and should be exited from the study (Section 19.1.).  
• Increases in dose of topical ophthalmic NSAIDs in the study eye  
• Any corticosteroid implant (ie, Ozurdex®, Iluvien® or Retisert™) in the study eye 
• Topical, periocular or intravitreal corticosteroids in the study eye  
• Increases in dose of systemic prednisone or other equivalent steroid (eg, dexamethasone), 
including, but not limited to, the following routes: oral, intravenous, intramuscular, in 
sufficient doses and/or for sufficient time such that the Investigator has concerns about 
additional ocular exposure to steroids in terms of safety and/or efficacy 
• Anti-angiogenic drugs (anti-VEGF) in the study eye or systemically (including 
pegaptanib sodium, bevacizumab, ranibizumab) 
• Increases to dose of systemic immunosuppressant drugs 
• Acetazolamide (Diamox®) 
• Any investigational drug or device 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 16 of 36 
CONFIDENTIAL 
 
 
In cases where a subject presents with a medication not included on the above list, or should 
there be any question on the part of the Investigator, Investigators are encouraged to confer with 
the Medical Monitor for any clarification. 
9.2.2. 
Additional Treatment 
If at any time during the study a subject is considered at immediate risk for a vision-threatening 
event, the Investigator should immediately follow best medical practice in the Investigator’s 
judgment for treating the subject. All additional therapy will be recorded in the subject’s medical 
chart and the CRF.  
Rescue Criteria 
If at any time during the study any of the following criteria are met in the study eye, the 
use of a treatment should be introduced. The therapy implemented is left to the discretion 
of the Investigator.   
• A loss of 10 or more ETDRS BCVA letters due to uveitis from either of the 
previous two visits 
• CSF > 320 µm OR an increase in CST of  ≥100 microns or 20%, whichever is 
lower, from either of the previous two visits 
• In the investigator’s medical judgement, the uveitic complications in the study 
eye have worsened and the condition needs to be addressed 
 
9.3. 
Treatment Compliance 
Once a subject has been treated with additional therapy, the subject should be exited from the 
study per the Schedule of Assessments (Section 20.1 - Appendix A). 
 
9.4. 
Randomization and Blinding 
While there will be no randomization in this non-interventional extension study, the masking 
from the Parent study will be protected in this trial until the Parent study has completed and is 
appropriately unmasked. 
 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 17 of 36 
CONFIDENTIAL 
 
 
10. 
STUDY DRUG MATERIALS AND MANAGEMENT 
Not Applicable 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 18 of 36 
CONFIDENTIAL 
 
 
11. 
ASSESSMENT OF EFFICACY 
 
11.1. 
Best Corrected Visual Acuity (BCVA)   
Best Corrected Visual Acuity (BCVA) will be measured using ETDRS electronic visual acuity 
(eVA) and will be collected at every visit. BCVA will be recorded as total letter score in each 
eye following refraction. Visual acuity testing should precede any examination requiring contact 
with the eye.  
In order to provide standardization and well-controlled assessments of BCVA during the study, 
all BCVA assessments must be performed by trained staff who are certified on the study 
procedure using certified VA equipment/lanes. 
If eVA cannot be performed for any reason, BCVA will be measured using a standard ETDRS 
chart. If Roman letters are not familiar to the subject, Tumbling E charts may be used. 
11.2. 
Central Subfield Thickness as Measured by SD-OCT  
Retinal thickness and disease characterization will be assessed at every visit via spectral domain 
optical coherence tomography (SD-OCT) (Heidelberg SPECTRALIS® or Zeiss CirrusTM).  The 
SD-OCT instrument and technician must be certified prior to enrolling any subjects. The 
technician is encouraged to use the same certified photography equipment throughout the 
subject’s study participation. All photos should be taken by the same photographer, whenever 
possible, on each subject per research site. Images will be sent to a central reading facility for 
analysis and interpretation in a masked fashion. 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 19 of 36 
CONFIDENTIAL 
 
 
12. 
ASSESSMENT OF SAFETY 
12.1. 
Safety Parameters 
12.1.1. 
Intraocular Pressure  
Intraocular pressure (IOP) will be measured by applanation tonometery (Tonopen or Goldmann) 
at every visit and results will be recorded in mmHg. A single measurement will be made at 
approximately the same time of day. The technician is encouraged to use the same tonometry 
method throughout the subject’s study participation. Tonometers must be calibrated for accuracy 
before the first subject screening at that site and according to the manufacturer specifications 
during the study, until the last subject has exited the study at that site. 
12.1.2. 
Slit-Lamp Biomicroscopy  
Slit-lamp biomicroscopy, including magnification, will be performed at every visit and 
consistent with standard clinical practice. This procedure should be conducted in the same 
manner for all subjects and will include an assessment of each of the following as normal or 
abnormal: eyelids, cornea, anterior chamber, iris and lens. All abnormal findings will be 
described.  
 
12.1.2.1. Cataract Lens Grading 
If an abnormal finding of cataract is noted for the lens during the slit-lamp exam, the cataract 
should be assessed for nuclear opalescence, cortical opacity and posterior subcapsular opacity. 
Graders must verify training on the grading procedure provided in the Manual of Procedures. 
 
12.1.2.2. Anterior Chamber Cells 
Anterior chamber cells will be assessed clinically using a field size of 1 mm slit beam and using 
a standardized grading scale ranging from 0 to 4+, as defined in Table 1 (SUN 2005).  
Table 1: 
Anterior Chamber Cell Grading Scale 
Score 
Cells in Field 
0 
<1 
0.5+ 
1-5 
1+ 
6-15 
2+ 
16-25 
3+ 
26-50 
4+ 
>50 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 20 of 36 
CONFIDENTIAL 
 
 
12.1.2.3. Anterior Chamber Flare 
Anterior chamber flare will be assessed clinically via slit lamp using a standardized scale ranging 
from 0 to 4, as defined in Table 2 (SUN 2005).  
Table 2: 
Anterior Chamber Flare Grading Scale 
Score 
Description 
0 
None 
1+ 
Faint 
2+ 
Moderate (iris and lens details clear) 
3+ 
Marked (iris and lens details hazy) 
4+ 
Intense (fibrin or plastic aqueous) 
12.1.3. 
Dilated Ophthalmoscopy  
A dilated fundus examination at every visit will include an assessment of each of the following 
as normal or abnormal: vitreous, retina, macula, choroid and optic nerve. All abnormal findings 
will be described.  
 
12.1.3.1. Vitreous Haze 
Vitreous haze will be assessed clinically via indirect ophthalmoscopy using a standardized 
photographic scale ranging from 0 to 4, as defined in Table 3 (Nussenblatt 1985 as modified in 
Lowder 2011).  
 
Table 3: 
Scale for Determining Degree of Vitreous Haze 
Score 
Description 
0 
no inflammation 
+0.5 
trace inflammation (slight blurring of the optic disc margins and/or loss 
of the nerve fiber layer reflex) 
+1 
mild blurring of the retinal vessels and optic nerve 
+1.5 
optic nerve head and posterior retina view obscuration greater than +1 but 
less than +2 
+2 
moderate blurring of the optic nerve head 
+3 
marked blurring of the optic nerve head 
+4 
optic nerve head not visible 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 21 of 36 
CONFIDENTIAL 
 
 
12.2. 
Adverse and Serious Adverse Events 
12.2.1. 
Definition of Adverse Events 
 
12.2.1.1. Adverse Event (AE) 
An Adverse Event (AE) is any untoward medical occurrence associated with the use of a drug in 
humans and does not have to have a causal relationship with study treatment.   
An AE can therefore be any unfavorable and unintended sign (that could include a clinically 
significant abnormal laboratory finding), symptom, or disease temporally associated with the use 
of a medicinal product, whether or not considered related to the medicinal product. 
Whenever possible, the Investigator should group signs or symptoms that constitute a single 
diagnosis under a single AE term (eg, “cough, rhinitis and sneezing” might be grouped together 
as “upper respiratory tract infection”). 
An AE may include: 
• 
Any sign, medical diagnosis or symptom 
• 
Any new undesirable medical occurrence or unfavorable or unintended change of a pre-
existing condition that occurs during or after test article administration.  
NOTE:  
o The disease under study (ie, non-infectious uveitis) or sign or symptom associated with 
the disease are not considered adverse events, unless more severe than expected for the 
subject’s condition 
o Symptoms associated with disease, which are consistent with the subject's usual clinical 
course are not considered adverse events, unless the subject experiences worsening of 
symptoms more severe than expected or unless the symptom(s) meet the criteria for an SAE 
• 
Clinically significant (as determined by the Investigator) laboratory abnormalities, 
ophthalmic assessments or vital signs (eg, requiring discontinuation of test article, specific 
treatment or a change in subject management). If possible, abnormal laboratory results or 
changes in vital signs that meet the definition of an AE should be reported as a clinical 
diagnosis rather than the abnormal laboratory value (eg, “hypertension” rather than “blood 
pressure increased”) 
12.2.1.2. Serious Adverse Event (SAE) 
A serious adverse event is an AE occurring during any study phase (ie, baseline, treatment, 
washout, or follow-up), and at any dose of the investigational product, comparator or placebo, 
that fulfils one or more of the following: 
• 
Death 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 22 of 36 
CONFIDENTIAL 
 
 
• 
Life-threatening (ie, if in the view of the Investigator or Sponsor, the event’s occurrence 
places the subject at immediate risk of death); it does not include an AE that, had it occurred 
in a more severe form, might have caused death 
• 
In-patient hospitalization or prolongation of existing hospitalization 
o “In-patient” hospitalization means the subject has been formally admitted to a 
hospital for medical reasons.  This may or may not be overnight.  It does not include 
presentation at a casualty or emergency room. 
• 
A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
• 
A congenital anomaly in the offspring of a subject who received study drug 
• 
Important medical events that may not result in death, be life-threatening or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, 
they may jeopardize the subject and may require medical or surgical intervention to prevent 
one of the outcomes listed in this definition   
 
12.3. 
Relationship to Study Drug 
Causality is the relationship of an AE to study drug and will be assessed by the investigator as 
follows in Table 5:  
Table 5: Causality Definitions 
Causality 
Definition 
Related 
There is a reasonable causal association with 
administration of the study drug; the event is confirmed 
by stopping and/or restarting the drug or is not explained 
by any other reasonable hypothesis 
Not related 
There is no causal or temporal relationship to the study 
drug; related to other etiologies such as concomitant 
medications or conditions 
 
12.4. 
Recording Adverse Events 
Adverse events spontaneously reported by the patient/subject and/or in response to an open 
question from the study personnel or revealed by observation will be recorded during the study at 
the investigational site.  The AE term should be reported in standard medical terminology when 
possible. For each AE, the investigator will evaluate and report the onset (date and time), 
resolution (date and time), intensity, causality, action taken, serious outcome (if applicable), and 
whether or not it caused the patient to discontinue the study. 

CLS-TA, triamcinolone acetonide injectable suspension
   Clearside Biomedical, Inc 
CLS1001-303 
Clinical Protocol 
Version 2.0 
14 December 2016 
Page 23 of 36 
CONFIDENTIAL 
The intensity of each AE will be graded using National Cancer Institute (NCI) Common 
Terminology Criteria for Adverse Events (CTCAE) v 4.03. The criteria can be accessed at: 
http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. 
The term “severe” is a measure of intensity. A severe AE is not necessarily a serious AE. 
Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique 
clinical descriptions of severity for each AE based on this general guideline: 
Grade 1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated 
Grade 2 
Moderate; minimal, local or noninvasive intervention 
indicated; limiting age-appropriate instrumental activities of 
daily living (ADL) 
Grade 3 
Severe or medically significant but not immediately life-
threatening; hospitalization or prolongation of the 
hospitalization indicated; disabling; limiting self-care ADL 
Grade 4 
Life threatening consequences; urgent intervention indicated 
Grade 5 
Death related to AE 
12.5. 
Reporting Serious Adverse Events 
Prompt reporting of a SAE requires: 
•
Completion and transmission of SAE information to the Sponsor within 24 hours of the
investigator’s knowledge of the event.  The SAE information should be completed as
thoroughly as possible before transmittal to the Sponsor. It is very important that the
investigator provide his/her assessment of causality to study treatment at the time of
initial reporting of the SAE.
•
Prompt reporting of additional information for previously reported SAEs should follow
the same reporting timeframe as initial reports.
If an ongoing SAE changes in intensity or the relationship to study drug, a follow-up SAE report 
should be sent to the Sponsor within 24 hours after the clinical site becomes aware of the change 
in status. 
12.5.1. 
Transmission of SAE Reports 
An adverse event that is serious must be reported on an SAE form to the Sponsor immediately, 
but no later than 24 hours after the investigator becomes aware of the event.  

CLS-TA, triamcinolone acetonide injectable suspension
   Clearside Biomedical, Inc 
CLS1001-303 
Clinical Protocol 
Version 2.0 
14 December 2016 
Page 24 of 36 
CONFIDENTIAL 
SAE reporting information should be transmitted to the Sponsor via email or fax as provided 
below.  
Chiltern, Inc. 
GlobalSAEInbox@chiltern.com 
Toll free fax US:  
888-726-8416
Toll free fax India: 
91-2266-459-811
Please refer to the study reference binder for complete contact information. Contact the Medical 
Monitor with any questions regarding a potential SAE. 
If an ongoing SAE changes in intensity or the relationship to study drug, a follow-up SAE report 
should be sent to the Sponsor within 24 hours after the clinical site becomes aware of the change 
in status. 
12.5.2. 
Regulatory Reporting Requirements for SAEs 
The Sponsor will determine which SAEs qualify for expedited reporting. Reports of those SAEs 
that qualify for expedited reporting will be unmasked for the individual subject and submitted to 
regulatory agencies in accordance with applicable local regulation. Expedited reports will also be 
distributed to Investigators without revealing the treatment assignment and will be submitted to 
IRB/IEC in accordance with institutional guidelines and local regulation. 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 25 of 36 
CONFIDENTIAL 
 
 
13. 
STATISTICS 
A detailed statistical analysis plan will be prepared for this study.  The plan will contain a 
discussion of the statistical methods, a description of the computational algorithms and data 
handling conventions, and specifications for the data summaries and listings.  It will be finalized 
before database lock. 
13.1. 
Randomization 
There will be approximately 30 subjects enrolled from the Parent study, CLS1001-301, where 
there were two masked arms (4.0 mg CLS-TA and sham). No additional randomization is 
planned for this study.  
13.2. 
Determination of Sample Size and Level of Significance 
The sample size of approximately 30 subjects at approximately 40 centers was based on clinical 
considerations appropriate for a non-interventional extension study.  
13.3. 
Subject Disposition, Demographic and Baseline Characteristics 
Subject disposition, demographic, and baseline characteristics (sourced from the Parent study) 
will be summarized descriptively by treatment group and overall. 
13.4. 
Analysis Population 
13.4.1. 
Safety Population 
Safety population will include all enrolled subjects who successfully complete the crossover visit 
(Day 0). The Safety Population will be used for safety analyses. 
13.4.2. 
Intent-to-Treat Population 
Intent-to-treat (ITT) population includes all enrolled subjects. ITT population will be used for 
efficacy analyses. 
13.5. 
Analysis Methods 
13.5.1. 
Primary Efficacy Endpoint 
Time to rescue therapy (dosing with a drug when efficacy of the Parent study investigational 
products is no longer adequate) 
 
13.5.2. 
Primary Efficacy Analysis 
All data collected in the study database will be presented in the listings. Listings will include 
change from baseline. Baseline is the Crossover Visit. 
Time to Rescue Therapy will be analyzed using Kaplan-Meier analysis including 95% 
confidence intervals, log rank p-value for difference between treatments, and quartiles. 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 26 of 36 
CONFIDENTIAL 
 
 
 
13.5.3. 
Safety Endpoint 
• 
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), 
grouped by organ system, relatedness to study medication, and severity 
• 
Percentage of subjects whose IOP increases are > 10 mmHg from their own Parent study 
baseline measurement at each follow-up visit  
• 
Percentage of subjects whose IOP increases to a reading > 30 mmHg at each follow-up visit  
• 
Percentage of subjects who require 1 or more additional IOP lowering medications at any 
follow-up visit 
13.5.4. 
Safety Analysis  
13.5.4.1. Intraocular Pressure 
The observed and change from baseline in IOP will be summarized descriptively at each visit.  
Descriptive statistics include n, mean, median, minimum and maximum values.   
13.5.4.2. Cataract Lens Grading 
The distribution of responses (n, %) will be tabulated for each category of response. 
13.5.4.3. Slit-Lamp Biomicroscopy  
The distribution of responses (n, %) will be tabulated for each category of response. 
13.5.4.4. Dilated Indirect Ophthalmoscopy 
The distribution of responses (n, %) will be tabulated for each category of response. 
13.5.4.5. Adverse Events 
AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding 
dictionary.  TEAEs will be defined as any event occurring post treatment (injection) in the parent 
study or, if pre-existing, worsening after Day 0 in this extension study.   
The incidence of TEAEs will be summarized by MedDRA system organ class and preferred 
term.  If the subject reports the same AE more than once, then that subject will only be counted 
once for the summary of that AE, using the most severe intensity and closest relationship to 
study treatment. 
TEAEs will be summarized as follows: 
• All TEAEs 
• All TEAEs by intensity 
• ALL TEAEs related to study drug 
• Treatment-emergent SAEs 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 27 of 36 
CONFIDENTIAL 
 
 
• TEAEs that lead to premature discontinuation of study drug   
• If few AE are reported, AEs will only be provided in a listing 
13.5.4.6. Prior and Concomitant Medications 
Concomitant medications specific to ocular indications will be carried over from the parent study 
and entered as ongoing or new medications at the Crossover Visit (Day 0), then any additional 
medications or deletions will be recorded in the study and will be summarized.   
13.5.5. 
Interim Analysis 
There is no interim analysis planned for this study.   
13.5.6. 
Extent of Exposure 
There will be no exposure to CLS-TA or SHAM device in this study.  
13.5.7. 
Procedure for Accounting for Missing, Unused, or Spurious Data 
Any missing, unused, or spurious data will be noted in the final clinical report. 
No imputation is planned for the safety data set.  
13.5.8. 
Multiplicity 
Since there is only one primary endpoint, no multiplicity adjustments are required for the 
primary analysis. 
13.5.9. 
Procedure for Reporting Deviations from the Statistical Analysis Plan 
Any deviations from the statistical analysis plan will be described and a justification given in the 
final clinical study report. 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 28 of 36 
CONFIDENTIAL 
 
 
14. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
14.1. 
Study Monitoring 
Site qualification visits for this study will be waived due to the fact that a member of the 
Clearside Biomedical team or representative have monitored the site for the parent study during 
the last 6 months and the adequacy of the Investigator, site personnel and facilities have been 
documented in the site monitoring visit reports (with exception in the event that significant staff 
or facility changes have occurred since the last visit). 
During the study, a monitor from Clearside Biomedical or representative will have regular 
contacts with the investigational site, for the following: 
• Provide information and support to the investigator(s) 
• Confirm that facilities remain acceptable 
• Confirm that the investigational team is adhering to the protocol, that data are being 
accurately recorded in the case report forms, and that investigational product 
accountability checks are being performed 
• Perform source data verification. This includes a comparison of the data in the case report 
forms with the patient’s medical records at the hospital or practice, and other records 
relevant to the study. This will require direct access to all original records for each patient 
(e.g. clinic charts). 
• Record and report any protocol deviations not previously sent to Clearside Biomedical. 
• Confirm AEs and SAEs have been properly documented on CRFs and confirm any SAEs 
have been forwarded to Clearside Biomedical and those SAEs that met criteria for 
reporting have been forwarded to the IRB. 
The monitor will be available between visits if the investigator(s) or other staff needs 
information or advice. 
 
14.2. 
Audits and Inspections 
Authorized representatives of Clearside Biomedical, a regulatory authority, an Independent 
Ethics Committee or an Institutional Review Board may visit the site to perform audits or 
inspections, including source data verification.  The purpose of a Clearside Biomedical audit or 
inspection is to systematically and independently examine all study-related activities and 
documents to determine whether these activities were conducted, and data were recorded, 
analyzed, and accurately reported according to the protocol, Good Clinical Practice guidelines of 
the International Conference on Harmonization, and any applicable regulatory requirements.  
The investigator should contact Clearside Biomedical immediately if contacted by a regulatory 
agency about an inspection. 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 29 of 36 
CONFIDENTIAL 
 
 
14.3. 
Institutional Review Board (IRB) 
The Principal Investigator must obtain IRB approval for the investigation.  Initial IRB approval, 
and all materials approved by the IRB for this study including the patient consent form and 
recruitment materials must be maintained by the Investigator and made available for inspection. 
 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 30 of 36 
CONFIDENTIAL 
 
 
15. 
QUALITY CONTROL AND QUALITY ASSURANCE 
To ensure compliance with Good Clinical Practices and all applicable regulatory requirements, 
Clearside Biomedical may conduct a quality assurance audit.  Please see Section 14.2 for more 
details regarding the audit process. 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 31 of 36 
CONFIDENTIAL 
 
 
16. 
ETHICS 
16.1. 
Ethics Review 
The final study protocol, including the final version of the Informed Consent Form, must be 
approved or given a favorable opinion in writing by an IRB or IEC as appropriate.  The 
investigator must submit written approval to Clearside Biomedical before he or she can enroll 
any patient/subject into the study. 
The Principal Investigator is responsible for informing the IRB or IEC of any amendment to the 
protocol in accordance with local requirements.  In addition, the IRB or IEC must approve all 
advertising used to recruit patients for the study.  The protocol must be re-approved by the IRB 
or IEC upon receipt of amendments and annually, as local regulations require. 
The Principal Investigator is also responsible for providing the IRB with reports of any 
reportable serious adverse drug reactions from any other study conducted with the investigational 
product. Clearside Biomedical will provide this information to the Principal Investigator. 
Progress reports and notifications of serious adverse drug reactions will be provided to the IRB 
or IEC according to local regulations and guidelines. 
 
16.2. 
Ethical Conduct of the Study 
The study will be performed in accordance with ethical principles that have their origin in the 
Declaration of Helsinki and are consistent with ICH/Good Clinical Practice, applicable 
regulatory requirements. 
 
16.3. 
Written Informed Consent 
The Principal Investigator(s) at each center will ensure that the patient is given full and adequate 
oral and written information about the nature, purpose, possible risk and benefit of the study. 
Patients must also be notified that they are free to discontinue from the study at any time. The 
patient should be given the opportunity to ask questions and allowed time to consider the 
information provided. 
 
The patient’s signed and dated informed consent must be obtained before conducting any study 
procedures. 
 
The Principal Investigator(s) must maintain the original, signed Informed Consent Form.  A copy 
of the signed Informed Consent Form must be given to the patient. 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 32 of 36 
CONFIDENTIAL 
 
 
17. 
DATA HANDLING AND RECORD KEEPING 
17.1. 
Inspection of Records 
Clearside Biomedical will be allowed to conduct site visits to the investigation facilities for the 
purpose of monitoring any aspect of the study. The Investigator agrees to allow the monitor to 
inspect the drug storage area, study drug stocks, drug accountability records, subject charts and 
study source documents, and other records relative to study conduct. 
 
17.2. 
Retention of Records 
The Principal Investigator must maintain all documentation relating to the study for a period of 2 
years after the last marketing application approval, or if not approved 2 years following the 
discontinuance of the test article for investigation or as per local and country regulations. If it 
becomes necessary for Clearside Biomedical or the Regulatory Authority to review any 
documentation relating to the study, the Investigator must permit access to such records. 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 33 of 36 
CONFIDENTIAL 
 
 
18. 
PUBLICATION POLICY 
The institution and investigators participating in this trial shall have no right to publish or present 
the results of this study without the prior written consent of Clearside Biomedical. 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 34 of 36 
CONFIDENTIAL 
 
 
19. 
LIST OF REFERENCES 
Bodaghi B, Cassoux N, Bertrand W, et al. Chronic severe uveitis: etiology and visual outcome in 
927 patients from a single center. Medicine. 2001;80:263-270. 
Dick AD. The treatment of chronic uveitic macular edema. Br J Ophthalmol. 1994;78:1-2. 
Goldstein DA, Pyatetsky D, Tessler HH.  Classification, symptoms, and signs of uveitis.  
Duane’s Ophthalmology on DVD-ROM Ed 2009a:chap 32. 
Karim R, Sykakis E, Lightman S, Fraser-Bell S. Interventions for the treatment of uveitic 
macular edema: a systematic review and meta-analysis. Clin Opthalmol. 2013;7:1109-1144. 
Lardenoye C, Kooji B, Rothova A. Impact of macular edema on visual acuity in uveitis. 
Ophthalmology 2006;113:1446-1449. 
Lowder C, Belfort R, Lightman S, et al. Dexamethasone Intravitreal Implant for Noninfectious 
Intermediate or Posterior Uveitis. Arch Ophthalmol. 2011;129(5):545-553. 
Miserocchi E, Fogliato G, Modorati G and Bandello F. Review on the worldwide epidemiology 
of uveitis. Eur J Ophthalmol. 2013;23:705-717. 
Nussenblatt RB, Palestine AG, Chan CC, Roberge F. Standardization of vitreal inflammatory 
activity in intermediate and posterior uveitis. Ophthalmology. 1985;92(4):467– 471. 
Rothova A, Suttorp-van Schulten SA, Treffers WF and Kijlstra A. Causes and frequency of 
blindness in patients with intraocular inflammatory disease. Br J Ophalmol. 1996;80:332-336. 
SUN Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results 
from the first international workshop. Am J Ophthalmol 2005;150:509-516. 
Triesence [Package Insert]. Fort Worth, Texas: Alcon Laboratories, Inc., 2007. 
Wood B. An overview of uveitis and its management. US Pharmacist 2011. 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 35 of 36 
CONFIDENTIAL 
 
 
20. 
APPENDICES 
20.1. 
Appendix A: Schedule of Assessments 
 
Assessment 
Crossover1 
Extension Study Visit 
Early 
Termination 
Parent Study 
Week 24 
Week 30 
Week 36 
Week 42 
Week 48 
 
Extension Study 
Day 0 
Week 6 
Week 12 
Week 18 
Week 24 
 
Informed Consent 
X 
 
 
 
 
 
Inclusion/ 
Exclusion 
X 
 
 
 
 
 
Assess AEs 
X 
X 
X 
X 
X 
X 
Con Med Review 
X 
X 
X 
X 
X 
X 
BCVA2 
X 
X 
X 
X 
X 
X 
Slit lamp 
Biomicroscopy2,3 
X 
X 
X 
X 
X 
X 
IOP2 
X 
X 
X 
X 
X 
X 
Dilated Indirect 
Ophthalmoscopy2 
X 
X 
X 
X 
X 
X 
SD-OCT2 
X 
X 
X 
X 
X 
X 
1 
Same as parent study Week 24 visit. Ensure these procedures are completed. Do not repeat if done in parent study.  
2 
All ophthalmic assessments should be completed for the study eye only 
3 
Any finding of cataract should be graded 
 

CLS-TA, triamcinolone acetonide injectable suspension                                                       Clearside Biomedical, Inc  
CLS1001-303 
 
Clinical Protocol 
 
 
Version 2.0 
14 December 2016 
Page 36 of 36 
CONFIDENTIAL 
 
 
20.2. 
Appendix B: SUMMARY OF CHANGES FOR AMENDMENTS 
 
Section Changed 
Initial Protocol  
(Changed From) 
Modified Protocol  
(Changed To) 
Reason for Change 
Impact on Subjects 
(Risk/Benefit) 
Throughout protocol 
Miscellaneous incorrect 
reference section numbers 
Reference section numbers 
corrected 
To correct reference section 
numbers 
None 
Section 20.1. Appendix A 
Schedule of Assessments 
Footnote #2. All ophthalmic 
assessments should be completed 
for both eyes 
 
 
Footnote #2. All ophthalmic 
assessments should be 
completed for the  study eye 
only 
To clarify that assessments are 
only required for study eye 
None