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

Alcon

Status and phase: Completed; Phase 2

Conditions: Geographic Atrophy

Treatments: Drug: LFG316; Drug: CLG561; Drug: Sham injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02515942

CCLG561X2201 (Other Identifier)

CLG561-2201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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114 participants in 3 patient groups

CLG561

Experimental group

Description:

CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections

Treatment:

Drug: CLG561

CLG561+LFG316

Experimental group

Description:

CLG561 5mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections

Treatment:

Drug: CLG561

Drug: LFG316

Sham Injection

Sham Comparator group

Description:

One sham injection every 28 days for total of 12 sham injections

Treatment:

Drug: Sham injection