Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
| Status: | Terminated |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/8/2019 |
| Start Date: | July 21, 2016 |
| End Date: | January 31, 2018 |
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
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.
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.
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
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University of South Florida The University of South Florida is a high-impact, global research university...
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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8411 North Run Medical Drive
Richmond, Virginia 23226
Richmond, Virginia 23226
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