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COMPLETED Phase 1

A Clinical Trial of Retinal Gene Therapy for X-linked Retinitis Pigmentosa Using BIIB112

NCT03116113 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 50 participants
Start Date 2017-03-08
Est. Completion 2020-11-18
Phase Phase 1

Sponsor

Biogen

74 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03116113

The ClinicalTrials.gov registry entry for NCT03116113 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03116113 reports 8 study locations spanning 5 distinct geographic areas — top geographies include Other, Florida, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03116113?

The interventions under investigation include: BIIB112 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03116113?

This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial