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

NCT03584165 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2025-06-12

No results posted yet for this study

Summary

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.

Conditions

  • Choroideremia
  • X-Linked Retinitis Pigmentosa

Interventions

GENETIC

BIIB111

Administered as specified in the treatment arm.

GENETIC

BIIB112

Administered as specified in the treatment arm.

Sponsors & Collaborators

  • NightstaRx Ltd, a Biogen Company

    lead OTHER

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-04
Primary Completion
2026-06-04
Completion
2026-06-04
FDA Drug
Yes

Countries

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

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03584165 on ClinicalTrials.gov