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NCT03507686 · ClinicalTrials.gov registry record · Phase 2
A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT03507686: Completed Phase 2 study, sponsored by Biogen.
NCT03507686 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03507686, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
The objective of the study is to evaluate the safety of bilateral, sequential sub-retinal administration of a single dose of BIIB111 in adult male participants with Choroideremia (CHM).
Primary Outcome
BCVA was assessed for both eyes using the ETDRS visual acuity (VA) chart. BCVA test should be performed prior to pupil dilation, and distance refraction should be carried out before BCVA is measured. Initially, letters are read at a distance of 4 meters from the chart. If \<20 letters are read at 4 meters, testing at 1 meter should be performed. BCVA is reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters) in the study eyes. The low
Interventions
- DRUG BIIB111
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2017-11-29 |
| Est. Completion | 2022-06-29 |
| Phase | Phase 2 |
What the finished NCT03507686 record still lists
NCT03507686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which BIIB111 is the first listed.
NCT03507686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03507686 about?
NCT03507686 is a clinical study titled "A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111". The objective of the study is to evaluate the safety of bilateral, sequential sub-retinal administration of a single dose of BIIB111 in adult male participants with Choroideremia (CHM).
What is the current status of trial NCT03507686?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2017-11-29. Estimated completion is 2022-06-29.
What interventions are being tested in trial NCT03507686?
The interventions under investigation include: BIIB111 (DRUG).
Who is sponsoring clinical trial NCT03507686?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03507686's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 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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