Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis Pigmentosa (SOLSTICE)
Choroideremia, X-Linked Retinitis Pigmentosa
About this trial
This is an interventional other trial for Choroideremia focused on measuring NightstaRx, Biogen, NSR-REP1, CHM, Gene Therapy, AAV, REP1, AAV8, RPGR
Eligibility Criteria
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.
Sites / Locations
- UCLA - Jules Stein Eye Institute
- Vitreo Retinal Associates PA - The Millennium Center
- University of Miami
- Johns Hopkins Hospital
- MEEI Massachusets Eye and Ear Infirmary
- Columbia University Medical Center
- Cincinnati Eye Institute - Blue Ash
- OHSU - Casey Eye Institute
- Retina Foundation of the Southwest
- University of Wisconsin School of Medicine
- Instituto Genetica Ocular
- The Northern Alberta Clinical Trials and Research Centre
- The University of British Columbia - Eye Care Centre
- McGill University Health Centre
- Rigshospitalet-Glostrup, Oejenafdelingen
- Helsinki University Central Hospital (HUCH)
- CHU Montpellier - Saint Eloi
- Centre Hospitalier National d Ophtalmologie (CHNO) des Quinze-Vingts
- Universitäts-Augenklinik Bonn
- Universitats Klinikum Tubingen - Institute for Ophthalmic Research
- Radboudumc
- Moorfields Eye Hospital
- Manchester Royal Eye Hopsital
- John Radcliffe Hospital
- Southampton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
BIIB111
BIIB112
Untreated
Participants previously treated with sub-retinal injection of BIIB111 in antecedent studies 273CH301 (NCT03496012) and 273CH203 (NCT03507686) will be enrolled. Participants previously treated with this same sub-retinal injection (rAAV2-REP1) in antecedent studies 20150371 (NCT02553135), Pro00028599 (NCT02077361), THOR-TUE-01 (NCT02671539), CHM09/01 (NCT01461213) and REGEN2015 (NCT02407678) will also be invited for enrollment. This is a follow-up study, investigational product was administered in the previous study.
Participants previously treated with sub-retinal injection of BIIB112 in the antecedent study 274RP101 (NCT03116113) will be enrolled. This is a follow-up study, investigational product was administered in the previous study.
Untreated participants who served as controls in the antecedent study 273CH301 (NCT03496012), investigating treatment with BIIB111, will be enrolled. This is a follow-up study, participants will not be administered study medication nor receive a sham surgery.