NCT03584165CompletedPhase 3
Long-term Safety and Efficacy Follow-up of BIIB111 for the Treatment of Choroideremia and BIIB112 for the Treatment of X-Linked Retinitis Pigmentosa
A Long-term Follow-up Study to Evaluate the Safety and Efficacy of Retinal Gene Therapy in Subjects With Choroideremia Previously Treated With Adeno-Associated Viral Vector Encoding Rab Escort Protein-1 (AAV2-REP1) and in Subjects With X-Linked Retinitis Pigmentosa Previously Treated With Adeno-Associated Viral Vector Encoding RPGR (AAV8-RPGR) in an Antecedent Study
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 277 (actual)
- First submitted
- 29 Jun 2018
- Start date
- 4 Jun 2018
- Primary completion date
- 22 Jun 2026
- Lead sponsor
- NightstaRx Ltd, a Biogen Company
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT03584165
- EU CT number
- 2023-507994-16-00
- EudraCT number
- 2017-003104-42
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 277
- From 4 Jun 2018 to the primary completion date, 22 Jun 2026
- 24 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Participants are not eligible for study participation if they meet the following exclusion criterion.
- 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.
Who the study is looking for
- CHM Participants
- 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
- Have received a sub-retinal injection of BIIB112 for XLRP and have exited an antecedent study.
Age in the registry: 18 years to 64 years · Sex: Male · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Genetica Ocular Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| The Northern Alberta Clinical Trials and Research Centre Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The University of British Columbia - Eye Care Centre Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Completed |
| Rigshospitalet-Glostrup, Oejenafdelingen Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Unknown status |
| Helsinki University Central Hospital (HUCH) Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Completed |
| CHNO des Quinze Vingts Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Moorfields Eye Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Manchester Royal Eye Hopsital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| MEEI Massachusets Eye and Ear Infirmary Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cincinnati Eye Institute - Blue Ash Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Retina Foundation of the Southwest Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Vitreo Retinal Associates PA - The Millennium Center Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| UCLA Jules Stein Eye Institute Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Wisconsin School of Medicine Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| OHSU Casey Eye Institute Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.