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
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