CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-25

Study Completion Date

2017-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Geographic Atrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Intervention Type DRUG

Sham injection

Empty syringe (without a needle) placed against the eye

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Sign written informed consent form;
* Geographic atrophy in both eyes;

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;

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No