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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Collaborator: Novartis Institutes for BioMedical Research

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.