At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 169 enrolled
Drug / intervention
BIIB111genetic
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating BIIB111 for Choroideremia. Completed, enrolled 169 participants across 18 sites in 8 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChoroideremia
CountriesCanada, Denmark, Finland, France, Germany, Netherlands, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartDec 2017
First PostedApr 2018
Primary CompletionDec 2020
TodayJul 2026
First PostedApr 12, 2018
Enrollment StartDec 11, 2017
Primary CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 8.2 years ago
Interventions
BIIB111genetic
Administered as specified in the treatment arm.