Status:
TERMINATED
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Geographic Atrophy
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 partici...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2018
Estimated Enrollment :
975 Patients enrolled
Trial Details
Trial ID
NCT02247531
Start Date
October 6 2014
End Date
January 23 2018
Last Update
October 15 2019
Active Locations (153)
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1
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
2
Retina Associates Southwest PC
Tucson, Arizona, United States, 85750
3
Retina Consultants of Orange County
Fullerton, California, United States, 92835
4
UCSD Shiley Eye Center
La Jolla, California, United States, 92093-0946