Long-term Safety and Efficacy Follow-up of AAV2-REP1 for the Treatment of Choroideremia (SOLSTICE) (SOLSTICE)
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This is a long-term follow up evaluating the safety and efficacy of AAV2-REP1 used in antecedent choroideremia studies.
Condition or disease
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.
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
Actual Study Start Date :
June 4, 2018
Estimated Primary Completion Date :
Estimated Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients previously treated with AAV2-REP1 in an antecedent study.
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.