Trials / Completed
CompletedNCT03496012
Efficacy and Safety of BIIB111 for the Treatment of Choroideremia
A Randomised, Open Label, Outcomes-Assessor Masked, Prospective, Parallel Controlled Group, Phase 3 Clinical Trial of Retinal Gene Therapy for Choroideremia Using an Adeno-Associated Viral Vector (AAV2) Encoding Rab Escort Protein 1 (REP1)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 169 (actual)
- Sponsor
- Biogen · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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 |
|---|---|---|
| GENETIC | BIIB111 | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2017-12-11
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2018-04-12
- Last updated
- 2023-12-07
- Results posted
- 2023-12-07
Locations
18 sites across 8 countries: United States, Canada, Denmark, Finland, France, Germany, Netherlands, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03496012. Inclusion in this directory is not an endorsement.