A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Trial ID or NCT#
NCT02247531
Status
RECRUITING
Purpose
This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Official Title
A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Assess the Efficacy and Safety of Lampalizumab Administered Intravitreally to Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Eligibility Criteria
Ages Eligible for Study: Older than 50 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Participants aged greater than or equal to (>/=) 50 years - Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes
Exclusion Criteria:
- Ocular Exclusion Criteria (Study Eye): - History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD - Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy - Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Exclusion Criteria (Both Eyes): - GA in either eye due to causes other than AMD - Previous treatment with eculizumab, lampalizumab, and/or fenretinide
Investigator(s)
Theodore Leng, MD, FACS
Ophthalmologist
Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)
View on ClinicalTrials.gov
