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

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

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.

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.

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.