Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis Pigmentosa

ID#: NCT03584165

Age: 18 years - 66+

Gender: Male

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Enrolling by invitation

Start Date: June 04, 2018

End Date: June 04, 2026

Summary: The objective of the study is to evaluate the long-term safety and efficacy of a sub-retinal injection of BIIB111 in participants with Choroideremia (CHM) who have been previously treated with BIIB111 and who have exited an antecedent study; these treated participants will be compared with untreated control participants who have exited the STAR (NCT03496012) study and BIIB112 in participants with X-linked retinitis pigmentosa (XLRP) who have been previously treated with BIIB112 and who have exited an antecedent study.
Eligibility: Key

Inclusion Criteria: CHM Participants a. Have participated in and exited from an interventional study that investigated the safety and efficacy of a sub-retinal injection of BIIB111 for CHM. XLRP Participants a. Have received a sub-retinal injection of BIIB112 for XLRP and have exited an antecedent study. Key

Exclusion Criteria: Participants are not eligible for study participation if they meet the following exclusion criterion. a. In the opinion of the Investigator and/or the Sponsor, it is not in the participant's best interest to participate in the study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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