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NCT03496012 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of BIIB111 for the Treatment of Choroideremia
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 169
- Enrollment target
NCT03496012: Completed Phase 3 study, sponsored by Biogen.
NCT03496012 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 169 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03496012, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 169 participants
- Enrollment target
Study Summary
The objective of the study is to evaluate the efficacy and safety of a single sub-retinal injection of BIIB111 in 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. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of participants with a ≥15 -letter improvement
Interventions
- GENETIC BIIB111
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2017-12-11 |
| Est. Completion | 2020-12-01 |
| Phase | Phase 3 |
What the finished NCT03496012 record still lists
NCT03496012 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which BIIB111 is the first listed.
NCT03496012 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03496012 about?
NCT03496012 is a clinical study titled "Efficacy and Safety of BIIB111 for the Treatment of Choroideremia". The objective of the study is to evaluate the efficacy and safety of a single sub-retinal injection of BIIB111 in participants with choroideremia (CHM).
What is the current status of trial NCT03496012?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 169 participants. The study started on 2017-12-11. Estimated completion is 2020-12-01.
What interventions are being tested in trial NCT03496012?
The interventions under investigation include: BIIB111 (GENETIC).
Who is sponsoring clinical trial NCT03496012?
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 NCT03496012's enrollment target sits among peer trials
169 1459th of 2000 higher than 542 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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