Conditions: Geographic Atrophy Age-related Macular Degeneration
Keywords: AMD Age-related Macular Degeneration geographic atrophy GA Dry AMD Blindness Drusen GA lesion
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 158
Healthy volunteers: no

Brief summary:
This study was conducted in two parts; Part A and Part B: Part B was initially planned to include two cohorts. Cohort 2 was cancelled following an interim analysis for efficacy in Part A of the study, and not due to any safety issues or concerns. Cohort 2 is not referred to again and part B cohort 1 is referred to as part B alone in the remainder of the document and is the subject of this report.

Part B was conducted to assess the safety and tolerability of a single intravitreal (IVT) LFG316 10 mg/100 µL injection. There was no efficacy evaluation in Part B. The study employed a multicenter, randomized, sham - controlled, single masked design. Eight patients with advanced AMD were planned to be randomized in a 3:1 ratio to receive a single IVT dose of LFG316 (10 mg/100 µL) or sham injection. Patients assigned to a sham injection were treated the same as those assigned to LFG316, except that the hub of an empty syringe (without needle) was placed against the eye instead of the IVT injection.

Detailed description:

Arms:
arm 1: LFG316 10 mg/100 μL arm 2: Sham injection arm 3: LFG316 5 mg/ 50 μL

Interventions: intervention 1: LFG316 intervention 2: Sham intervention 3: LFG316 Lower dose
Intervention descriptions: intervention 1: LFG316 5 mg/50 μL solution for IVT injection, intervention 2: Sham injection (akin to intravitreal injection but without intravitreal needle; no investigational drug given) intervention 3: LFG316 5 mg/50 μL solution for IVT Injection

Protocol document: