NCT02745119

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

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 994 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	Lampalizumab	Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.

Timeline

• Start date: 2016-07-21
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2016-04-20
• Last updated: 2019-03-06
• Results posted: 2019-02-15

Locations

208 sites across 19 countries: United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Peru, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study