NCT02515942

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	CLG561
DRUG	LFG316
DRUG	Sham injection	Empty syringe (without a needle) placed against the eye

Timeline

• Start date: 2015-09-25
• Primary completion: 2017-08-14
• Completion: 2017-12-01
• First posted: 2015-08-05
• Last updated: 2019-05-30
• Results posted: 2018-12-19

Regulatory

• FDA-regulated drug study