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

Plain-language summary

This study provides long-term safety and efficacy follow-up for patients who received the gene therapies BIIB111 for choroideremia and BIIB112 for X-linked retinitis pigmentosa. Eligible participants previously received a sub-retinal injection of these therapies and exited an earlier study. It was conducted in Phase 3 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Completed

Sponsor

NightstaRx Ltd, a Biogen Company

Intervention

BIIB111, BIIB112

Start date

6/4/2018

Estimated completion

6/22/2026

Countries

United States, Brazil, Canada, Denmark, Finland, France, Germany, Netherlands, United Kingdom

Related genes

Locations

• Los Angeles, United States
• Gainesville, United States
• Miami, United States
• Baltimore, United States
• Boston, United States
• New York, United States
• Cincinnati, United States
• Portland, United States
• Dallas, United States
• Madison, United States
• São Paulo, Brazil
• Edmonton, Canada
• Vancouver, Canada
• Montreal, Canada
• Glostrup Municipality, Denmark
• Helsinki, Finland
• Montpellier, France
• Paris, France
• Bonn, Germany
• Tübingen, Germany
• Nijmegen, Netherlands
• London, United Kingdom
• Manchester, United Kingdom
• Oxford, United Kingdom
• Southampton, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.