A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
Summary
This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.
Timeline
- Start
- 2015-03-30
- Primary completion
- 2017-06-02
- Completion
- 2017-06-02
Outcome
Missed primary endpoint
registry analysis (superiority test); Sham Q2W vs Lampalizumab Q2W; p = 0.0428; Difference in Adjusted Means 0.435 (80% CI 0.162 to 0.707) NCT02288559 ↗
registry analysis (superiority test); Sham Q4W vs Lampalizumab Q4W; p = 0.3361; Difference in Adjusted Means -0.210 (80% CI -0.491 to 0.071) NCT02288559 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lampalizumab | Monoclonal antibody | 10 mg | Intravitreal |