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NCT03116113 · ClinicalTrials.gov registry record · Phase 1
A Clinical Trial of Retinal Gene Therapy for X-linked Retinitis Pigmentosa Using BIIB112
A Phase 1 study of X-Linked Retinitis Pigmentosa, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 8
- Study locations
NCT03116113: Completed Phase 1 study of X-Linked Retinitis Pigmentosa, sponsored by Biogen.
NCT03116113 is a Phase 1 study of X-Linked Retinitis Pigmentosa that has completed, run by Biogen. The registered enrollment target is 50 participants, roughly in line with the 52-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target. The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03116113, a Phase 1 study of X-Linked Retinitis Pigmentosa, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 8
- Study locations
Study Summary
The objective of the study is to evaluate the safety, tolerability and efficacy of a single sub-retinal injection of BIIB112 in participants with X-linked retinitis pigmentosa (XLRP).
Primary Outcome
DLTs are defined as any of the following events considered to be related to study drug: Sustained decrease in best-corrected visual acuity (BCVA) of ≥30 letters on the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart compared to baseline (sustained is defined as lasting 48 hours or more until recovery, with recovery defined as visual acuity (VA) returning to within 10 letters of baseline VA. An exception is made for surgery-related events occurring in close temporal association {withi
Conditions Studied
Interventions
- BIOLOGICAL BIIB112
Study Locations (8)
Other
- Research Site - Manchester
- Research Site - Oxford
- Research Site - Southampton
Florida
- Research Site - Gainesville
- Research Site - Miami
Oregon
- Research Site - Portland
Pennsylvania
- Research Site - Philadelphia
Texas
- Research Site - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2017-03-08 |
| Est. Completion | 2020-11-18 |
| Phase | Phase 1 |
What the finished NCT03116113 record still lists
NCT03116113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, roughly in line with the 52-participant average among 8 other X-Linked Retinitis Pigmentosa trials with a reported enrollment target.
The record links to 1 condition, with X-Linked Retinitis Pigmentosa appearing as the primary indexed condition, and to 1 intervention - of which BIIB112 is the first listed.
NCT03116113 lists 8 locations in 5 states (Other, Florida, Oregon).
Frequently Asked Questions
What is clinical trial NCT03116113 about?
NCT03116113 is a clinical study titled "A Clinical Trial of Retinal Gene Therapy for X-linked Retinitis Pigmentosa Using BIIB112". The objective of the study is to evaluate the safety, tolerability and efficacy of a single sub-retinal injection of BIIB112 in participants with X-linked retinitis pigmentosa (XLRP).
What is the current status of trial NCT03116113?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2017-03-08. Estimated completion is 2020-11-18.
What conditions does trial NCT03116113 study?
This clinical trial studies the following conditions: X-Linked Retinitis Pigmentosa.
What interventions are being tested in trial NCT03116113?
The interventions under investigation include: BIIB112 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03116113?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03116113 being conducted?
This trial has 8 study locations across Florida, Oregon, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for X-Linked Retinitis Pigmentosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03116113's enrollment target sits among peer trials
50 4th of 8 higher than 5 of 8 other X-Linked Retinitis Pigmentosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other X-Linked Retinitis Pigmentosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
4D-125 in Patients With X-Linked Retinitis Pigmentosa (XLRP)
ACTIVE NOT RECRUITING · Phase 1
-
Safety and Efficacy of rAAV2tYF-GRK1-RPGR in Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations
ACTIVE NOT RECRUITING · Phase 1
-
A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE)
ACTIVE NOT RECRUITING · Phase 2
-
A Follow-on Study for Second-Eye Treatment for Participants Previously Treated With Gene Therapy for X-Linked Retinitis Pigmentosa (XLRP)
ACTIVE NOT RECRUITING · Phase 2
-
A Clinical Trial Evaluating the Safety and Efficacy of a Single Subretinal Injection of AGTC-501 in Participants With XLRP
ACTIVE NOT RECRUITING · Phase 2
-
Follow-up Gene Therapy Trial for the Treatment of X-linked Retinitis Pigmentosa Associated With Variants in the RPGR Gene
ACTIVE NOT RECRUITING · Phase 3
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