Long-term Safety and Efficacy Follow-up of AAV2-REP1 for the Treatment of Choroideremia (SOLSTICE)
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/10/2018 |
| Start Date: | June 4, 2018 |
| End Date: | April 2024 |
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects With Choroideremia Treated Previously With Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) in an Antecedent Study
This is a long-term follow up evaluating the safety and efficacy of AAV2-REP1 used in
antecedent choroideremia studies.
antecedent choroideremia studies.
This is a prospective and part retrospective, multi-centre, observational, follow-up study
for subjects who have previously received a sub-retinal injection of AAV2-REP1 for the
treatment of choroideremia in an antecedent study. No further gene therapy will be given in
this protocol. Subjects will rollover into the current study when they complete the
antecedent study. The study will consist of up to 9 visits over a maximum 48-month study
period.
for subjects who have previously received a sub-retinal injection of AAV2-REP1 for the
treatment of choroideremia in an antecedent study. No further gene therapy will be given in
this protocol. Subjects will rollover into the current study when they complete the
antecedent study. The study will consist of up to 9 visits over a maximum 48-month study
period.
Inclusion Criteria:
- Are willing and able to give informed consent for participation in the study.
- Have received a sub-retinal injection of AAV2-REP1 for CHM in an antecedent study.
Exclusion Criteria:
- There are no exclusion criteria for this study.
We found this trial at
2
sites
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