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A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Recruiting
Trial ID: NCT02247531
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
Stanford Investigator(s)
Theodore Leng, MD, FACS
Associate Professor of Ophthalmology and, by courtesy, of Anesthesiology, Perioperative and Pain Medicine (Adult MSD)
Eligibility
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
Intervention(s):
drug: Lampalizumab
other: Sham Comparator
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305