Clinical trial NCT02515942: CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA)
Official title: A Randomized, Multi-Center, Single Masked, Sham Controlled, Proof-of-Concept Study of Intravitreal CLG561 as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Geographic Atrophy
Keywords: Geographic atrophy (GA)
Macular degeneration
Dry age-related macular degeneration (AMD)
Intravitreal (IVT)
Retinal diseases
Fundus auto fluorescence (FAF)
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
Collaborators: name: Novartis Institutes for BioMedical Research
First posted: 2015-08-05
Enrollment: 114
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days) intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as compared to sham in subjects with geographic atrophy.

Detailed description: This study consists of an up-to 30-day screening period, an approximately 336-day treatment period, and a follow-up period consisting of two visits occurring 4 and 16 weeks after the last administered injection.

Eligibility criteria: Inclusion Criteria:

* Sign written informed consent form;
* Geographic atrophy in both eyes;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Pregnant or lactating women and women of child-bearing potential;
* Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in this study;
* Any contraindications or hypersensitivities to any component of the LFG316 or CLG561 solution;
* Any contraindications to IVT injections;
* Ocular surgery in either eye within 90 days of screening;
* Uncontrolled ocular hypertension or glaucoma in the study eye;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug
timeFrame: Up to Day 421
measure: Mean Change From Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline (Day 1), Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309
measure: Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF)
timeFrame: Baseline (Day 1), Day 337
Secondary outcomes:
measure: Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF
timeFrame: Baseline (Day 1), Day 85, Day 169, Day 253
measure: Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF
timeFrame: Baseline (Day 1), Day 421
measure: Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS)
timeFrame: Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337
measure: Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS
timeFrame: Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337
measure: Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS
timeFrame: Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337
measure: Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS
timeFrame: Baseline (Day 1), Day 281, Day 309, Day 337
measure: Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS
timeFrame: Baseline (Day 1), Day 281, Day 309, Day 337
measure: Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS
timeFrame: Baseline (Day 1), Day 281, Day 309, Day 337
measure: Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS
timeFrame: Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337
measure: Total CLG561 Serum Concentrations up to Day 421
timeFrame: Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 85, Day 169, Day 253, Day 309, Day 337, Day 421
measure: Total LFG316 Serum Concentration up to Day 421
timeFrame: Baseline (Day 1), Day 337, Day 421
measure: Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421
timeFrame: Baseline (Day 1), up to Day 421
measure: Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421
timeFrame: Baseline (Day 1), up to Day 421
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sr Clinical Manager, Pharma, GCRA
role: STUDY_DIRECTOR
References: