Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis Pigmentosa
Completed · Phase 3
Conditions studied: Choroideremia, X-Linked Retinitis Pigmentosa
In brief
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.
Key facts
- Study ID
- NCT03584165
- Run by
- NightstaRx Ltd, a Biogen Company
- People needed
- 277
- Starts
- 2018-06-04
- Expected to finish
- 2026-06-22
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- UCLA - Jules Stein Eye Institute — Los Angeles, California, United States
- Vitreo Retinal Associates PA - The Millennium Center — Gainesville, Florida, United States
- University of Miami — Miami, Florida, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- MEEI Massachusets Eye and Ear Infirmary — Boston, Massachusetts, United States
- Columbia University Medical Center — New York, New York, United States
- Cincinnati Eye Institute - Blue Ash — Cincinnati, Ohio, United States
- OHSU - Casey Eye Institute — Portland, Oregon, United States
- Retina Foundation of the Southwest — Dallas, Texas, United States
- University of Wisconsin School of Medicine — Madison, Wisconsin, United States
- Instituto Genetica Ocular — São Paulo, Brazil
- The Northern Alberta Clinical Trials and Research Centre — Edmonton, Alberta, Canada
- The University of British Columbia - Eye Care Centre — Vancouver, British Columbia, Canada
- McGill University Health Centre — Montreal, Quebec, Canada
- Rigshospitalet-Glostrup, Oejenafdelingen — Glostrup Municipality, Denmark
- Helsinki University Central Hospital (HUCH) — Helsinki, Finland
- CHU Montpellier - Saint Eloi — Montpellier, France
- Centre Hospitalier National d Ophtalmologie (CHNO) des Quinze-Vingts — Paris, France
- Universitäts-Augenklinik Bonn — Bonn, Germany
- Universitats Klinikum Tubingen - Institute for Ophthalmic Research — Tübingen, Germany
- Radboudumc — Nijmegen, Netherlands
- Moorfields Eye Hospital — London, United Kingdom
- Manchester Royal Eye Hopsital — Manchester, United Kingdom
- John Radcliffe Hospital — Oxford, United Kingdom
- Southampton General Hospital — Southampton, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.