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

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.

Timeline

Start

2015-09-25

Primary completion

2017-08-14

Completion

2017-12-01

Outcome

Missed primary endpoint

registry analysis (superiority test); CLG561 vs Sham Injection; p = 0.1019; Treatment Effect -0.29 (80% CI -0.59 to 0.00); ANCOVA NCT02515942 ↗

Publications

• Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.

Drugs

Indications