At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 6 enrolled
Drug / intervention
Injection of AAV2-REP1 (10e11 vg)biological
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.
An Open Label Phase 2 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 2 clinical trial evaluating Injection of AAV2-REP1 (10e11 vg) for Choroideremia. Completed, enrolled 6 participants across 1 site.
Detailed Summary
Phase II gene therapy study, involving a total of 6 male patients with choroideremia. The study will be conducted at the Bascom Palmer Eye Institute, University of Miami. Patients will be required to attend a total of 11 study visits over a 24 month period with an additional 3 year follow-up.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChoroideremia
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedSep 2015
Primary CompletionFeb 2018
TodayJul 2026
First PostedSep 17, 2015
Enrollment StartSep 1, 2015
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.8 years ago
Interventions
Injection of AAV2-REP1 (10e11 vg)biological
Single Group: single arm study