CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
rAAV2-CB-hRPE65biological
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.

Search/NCT00749957
NCT00749957Phase 2Completed
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A Multiple-Site, Phase 1/2, Safety and Efficacy Trial of a Recombinant Adeno-associated Virus Vector Expressing RPE65 (rAAV2-CB-hRPE65) in Patients With Leber Congenital Amaurosis Type 2

Beacon Therapeutics·interventional·Posted Sep 10, 2008·Updated Dec 28, 2017

In Brief

A Phase 2 clinical trial evaluating rAAV2-CB-hRPE65 for Leber Congenital Amaurosis. Completed, enrolled 12 participants across 2 sites.

Detailed Summary

The purpose of the study is to evaluate the safety and efficacy of an adeno-associated virus vector expressing RPE65 in patients with Leber congenital amaurosis caused by mutations in the RPE65 gene. Funding Source - FDA OOPD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeber Congenital Amaurosis
CountriesUnited States
CollaboratorsOregon Health and Science University, University of Massachusetts, Worcester

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2008
Enrollment StartJun 17, 2009
Primary CompletionSep 23, 2014
Study CompletionSep 22, 2017
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.8 years ago

Interventions

rAAV2-CB-hRPE65biological

Recombinant adeno-associated virus vector expressing RPE65