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Summary

for people ages 50 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Keywords

Geographic Atrophy Macular Degeneration Atrophy Immunoglobulin Fab Fragments

Eligibility

You can join if…

Open to people ages 50 years and up

  • Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

You CAN'T join if...

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 (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

Locations

  • UCSF; Ophthalmology
    San Francisco, California, 94143, United States
  • W Coast Retina Med Group Inc
    San Francisco, California, 94107, United States
  • East Bay Retina Consultants
    Oakland, California, 94609, United States
  • California Retina Consultants
    Bakersfield, California, 93309, United States
  • California Retina Consultants
    Santa Barbara, California, 93103, United States
  • Retina-Vitreous Associates Medical Group
    Beverly Hills, California, United States
  • Jules Stein Eye Institute/ UCLA
    Los Angeles, California, 90095-7000, United States
  • Orange County Retina Med Group
    Santa Ana, California, 92705, United States
  • The Gavin Herbert Eye Institute - UC, Irvine
    Irvine, California, 92697-4375, United States
  • Retina Consultants of Nevada
    Henderson, Nevada, 89052, United States
  • Southern CA Desert Retina Cons
    Palm Desert, California, 92211, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02247479
Phase
Phase 3
Study Type
Interventional
Last Updated
November 29, 2017