A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
NCT02288559 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2019-09-25
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.
Conditions
Interventions
- OTHER
-
Sham
Sham injection will be administered as a matching intravitreal injection of lampalizumab.
- DRUG
-
Lampalizumab
10 mg dose of lampalizumab administered intravitreally
Sponsors & Collaborators
-
Genentech, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-30
- Primary Completion
- 2017-06-02
- Completion
- 2017-06-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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