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NCT03972709 · ClinicalTrials.gov registry record · Phase 2
A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
A Phase 2 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 2
- Development phase
- 372
- Enrollment target
NCT03972709: Clinical Trial Phase 2 study, sponsored by Genentech.
NCT03972709 is a Phase 2 study that was terminated before completion, run by Genentech. The registered enrollment target is 372 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (180% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03972709, a Phase 2 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 372 participants
- Enrollment target
Study Summary
This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab (FHTR2163) injections.
Primary Outcome
GA is an advanced stage of age-related macular degeneration (AMD) and is characterized by loss of photoreceptors, retinal pigment epithelium, and choriocapillaris. In the early stages of GA, patients typically show minimal changes in central visual acuity although patients often still experience significant symptoms from visual dysfunction, such as reduced contrast sensitivity, and a decrease in reading speed. In the later stages, as the GA lesion expands into the fovea, a profound decrease in c
Interventions
- DRUG Sham Control
- DRUG Galegenimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2022-10-27 |
| Phase | Phase 2 |
Why NCT03972709 stopped before completion
NCT03972709 is an interventional study that assigns participants to a tested intervention. The registered 372 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (180% higher).
The record links to 0 conditions, and to 2 interventions - of which Sham Control is the first listed.
NCT03972709 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03972709 about?
NCT03972709 is a clinical study titled "A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)". This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) com...
What is the current status of trial NCT03972709?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 372 participants. The study started on 2019-06-03. Estimated completion is 2022-10-27.
What interventions are being tested in trial NCT03972709?
The interventions under investigation include: Sham Control (DRUG), Galegenimab (DRUG).
Who is sponsoring clinical trial NCT03972709?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03972709's enrollment target sits among peer trials
372 118th of 2000 higher than 1,881 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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