Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)
Status:
Completed
Trial end date:
2015-06-24
Target enrollment:
Participant gender:
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.