Overview

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.