drugset
drugset / Trial / NCT03584165

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

NCT03584165 ↗

Phase 3 Completed 277 enrolled NightstaRx Ltd, a Biogen Company
Non-randomizedParallel-groupSingle-blindOther

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.

Timeline

Start
2018-06-04
Primary completion
2026-06-22
Completion
2026-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject BIIB111 Gene therapy (AAV / viral vector) — Other
Subject cotoretigene toliparvovec Gene therapy (AAV / viral vector) — Other

Indications

choroideremia retinitis pigmentosa