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A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects with Choroideremia Previously Treated with Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) and in Subjects with X-Linked Retinitis Pigmentosa Previously Treated with Adeno-Associated Viral Vector Encoding RPGR (AAV8-RPGR) in an Antecedent Study
EU CTIS ID: 2023-507994-16-00
What this study is testing
To evaluate the long-term safety and efficacy of a sub retinal injection of: AAV2-REP1 in participants with CHM who have been previously treated with AAV2-REP1 and who have exited an antecedent study; these treated participants will be compared with untreated control participants who have exited the STAR study. AAV8-RPGR in participants with XLRP who have been previously treated with AAV8-RPGR and who have exited an antecedent study.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- CHM Participants: a. Are willing and able to give informed consent for participation in the study, and
- CHM Participants: b. Have participated in and exited from an interventional study that investigated the safety and efficacy of a sub-retinal injection of AAV2- REP1 for CHM
- XLRP Participants: a. Are willing and able to give informed consent for participation in the study
- XLRP Participants: b. Have received a sub-retinal injection of AAV8-RPGR for XLRP and have exited an antecedent study
You likely can't join if
- In the opinion of the investigator and/or the Sponsor, it is not in the participant's best interest to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- United Kingdom
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; United Kingdom; Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.