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Galegenimab in Geographic Atrophy Secondary to AMD
NCT03972709Phase 2
Key facts
- Status
- Terminated
- Start
- Jun 2019
- Primary completion
- Oct 2022
- Countries
- 1
- Sponsor
- Genentech
- Modality
- Recombinant Proteins and Enzymes, Monoclonal Antibodies
- Drugs
- galegenimab
- Conditions
- geographic atrophy (GA)
01
Overview
Phase 2, randomised, single-blind trial of galegenimab in geographic atrophy (GA) (4 arms), sponsored by Genentech. Primary endpoint: Mean Change in Geographic Atrophy Area From Baseline at Week 72. Started Jun 2019; status: terminated.
02
Design
4 arms- Study design
- RandomizedSingle-blind
Galegenimab Q4W
Galegenimab every 4 weeks
Sham Control Q4W
Sham procedure every 4 weeks
Galegenimab Q8W
Galegenimab every 8 weeks
Sham Control Q8W
Sham procedure every 8 weeks
03
Who it enrols
Patients aged 60 or older with well-demarcated geographic atrophy secondary to AMD, BCVA >= 24 letters, and no prior AMD surgery or anti-VEGF treatment in the study eye.
04
Endpoints
Primary
Mean Change in Geographic Atrophy Area From Baseline
Secondary
Percentage of Participants With Ocular Adverse Events in the Study Eye
Percentage of Participants With Ocular Adverse Events in the Fellow Eye
Percentage of Participants With Systemic Adverse Events
Percentage of Participants With Serious Adverse Events
Percentage of Participants With Adverse Events of Special Interest
Percentage of Participants With Adverse Events Leading to Study Discontinuation
Mean Change in Best Corrected Visual Acuity Score From Baseline (Low-luminance)
Mean Change in Best Corrected Visual Acuity Score From Baseline
05
Results
Not all primary endpoints met
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