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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
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

NCT02247531

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Geographic Atrophy

Interventions: Lampalizumab, Sham Comparator

Countries: United States, Argentina, Australia, Austria, Belgium, Denmark, France, Germany

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).

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (153)
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Fullerton, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Mountain View, California, United States
  • Palo Alto, California, United States
  • Poway, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • Santa Barbara, California, United States
  • Walnut Creek, California, United States
  • Aurora, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Golden, Colorado, United States
  • Hamden, Connecticut, United States
  • Waterford, Connecticut, United States
  • Fort Lauderdale, Florida, United States
  • Fort Myers, Florida, United States
  • Naples, Florida, United States
  • St. Petersburg, Florida, United States
  • Tallahassee, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • West Des Moines, Iowa, United States
  • Wichita, Kansas, United States
  • Paducah, Kentucky, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Chevy Chase, Maryland, United States
  • + 123 more on CT.gov