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Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)

NCT02745119

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Geographic Atrophy

Interventions: Lampalizumab

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

This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit
* Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential

Exclusion Criteria:

* Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
* Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
* Increased risk of infection
* Pregnancy or lactation
Locations (208)
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Bakersfield, California, United States
  • Beverly Hills, California, United States
  • Fullerton, California, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Mountain View, California, United States
  • Oakland, California, United States
  • Palm Desert, California, United States
  • Palo Alto, California, United States
  • Poway, California, United States
  • Sacramento, California, United States
  • Sacramento, California, United States
  • San Francisco, California, United States
  • San Francisco, California, United States
  • Santa Ana, 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
  • New London, Connecticut, United States
  • Boynton Beach, Florida, United States
  • Fort Lauderdale, Florida, United States
  • Fort Myers, Florida, United States
  • Fort Myers, Florida, United States
  • + 178 more on CT.gov