Trials / Completed
CompletedNCT03507686
A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111
An Open-Label Safety Study of Retinal Gene Therapy for Choroideremia With Bilateral, Sequential Administration of Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Biogen · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This study was previously posted by NightstaRx Ltd. In October 2020, sponsorship of the trial was transferred to Biogen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BIIB111 | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2017-11-29
- Primary completion
- 2022-06-29
- Completion
- 2022-06-29
- First posted
- 2018-04-25
- Last updated
- 2024-02-23
- Results posted
- 2023-09-18
Locations
6 sites across 3 countries: United States, France, Germany
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03507686. Inclusion in this directory is not an endorsement.