Trials / 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
Completed Phase 3 Gene therapy
- Sponsor
- NightstaRx Ltd, a Biogen Company
- Treatment
- BIIB111; BIIB112
- Gene
- CHM, RPGR
- Conditions
- Choroideremia, X-Linked Retinitis Pigmentosa
- Ages
- 18 Years to no upper limit
- Enrollment
- 277 participants
- Started
- 2018-06-04
- Main results expected
- 2026-06-22
- Results posted
- Not yet
- Record last updated
- 2026-07-06
What the study is testing
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.
Where it runs
Brazil (1)
- Instituto Genetica Ocular, São Paulo
Canada (3)
- The Northern Alberta Clinical Trials and Research Centre, Edmonton, Alberta
- The University of British Columbia - Eye Care Centre, Vancouver, British Columbia
- McGill University Health Centre, Montreal, Quebec
Denmark (1)
- Rigshospitalet-Glostrup, Oejenafdelingen, Glostrup Municipality
Finland (1)
- Helsinki University Central Hospital (HUCH), Helsinki
France (2)
- CHU Montpellier - Saint Eloi, Montpellier
- Centre Hospitalier National d Ophtalmologie (CHNO) des Quinze-Vingts, Paris
Germany (2)
- Universitäts-Augenklinik Bonn, Bonn
- Universitats Klinikum Tubingen - Institute for Ophthalmic Research, Tübingen
Netherlands (1)
- Radboudumc, Nijmegen
United Kingdom (4)
- Moorfields Eye Hospital, London
- Manchester Royal Eye Hopsital, Manchester
- John Radcliffe Hospital, Oxford
- Southampton General Hospital, Southampton
United States (10)
- UCLA - Jules Stein Eye Institute, Los Angeles, California
- Vitreo Retinal Associates PA - The Millennium Center, Gainesville, Florida
- University of Miami, Miami, Florida
- Johns Hopkins Hospital, Baltimore, Maryland
- MEEI Massachusets Eye and Ear Infirmary, Boston, Massachusetts
- Columbia University Medical Center, New York, New York
- Cincinnati Eye Institute - Blue Ash, Cincinnati, Ohio
- OHSU - Casey Eye Institute, Portland, Oregon
- Retina Foundation of the Southwest, Dallas, Texas
- University of Wisconsin School of Medicine, Madison, Wisconsin