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COMPLETED Phase 1

Safety and Efficacy of rAAV-hRS1 in Patients With X-linked Retinoschisis (XLRS)

NCT02416622 · View on ClinicalTrials.gov ↗

Study Summary

This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector expressing retinoschisin (rAAV2tYF-CB-hRS1) in patients with X-linked retinoschisis. Up to 27 participants will be enrolled and 3 dose levels will be evaluated in a dose escalation format.

Conditions Studied

Interventions

  • BIOLOGICAL rAAV2tYF-CB-hRS1

Study Locations (9)

Texas

  • Retina Foundation of the Southwest — Dallas
  • Baylor College of Medicine, Alkek Eye Center — Houston

California

  • University of California San Francisco, Dept. of Ophthalmology — San Francisco

Florida

  • University of Miami - Miller School of Medicine Bascom Palmer Eye Institute — Miami

Maryland

  • The Wilmer Eye Institute, Johns Hopkins Hospital — Baltimore

Massachusetts

  • Massachusetts Eye and Ear Infirmary — Boston

Michigan

  • University of Michigan Kellogg Eye Center — Ann Arbor

North Carolina

  • Duke Eye Center, Duke University Medical Center — Durham

Oregon

  • Casey Eye Institute, Oregon Health and Sciences University — Portland

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2015-05
Est. Completion 2023-05-09
Phase Phase 1

Sponsor

Beacon Therapeutics

9 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02416622

The ClinicalTrials.gov registry entry for NCT02416622 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 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beacon Therapeutics, which has 9 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 Retinoschisis appearing as the primary indexed condition, and to 1 intervention — of which rAAV2tYF-CB-hRS1 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: NCT02416622 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Texas, California, Florida. 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 NCT02416622 about?

NCT02416622 is a clinical study titled "Safety and Efficacy of rAAV-hRS1 in Patients With X-linked Retinoschisis (XLRS)". This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector expressing retinoschisin (rAAV2tYF-CB-hRS1) in patients with X-linked retinoschisis. Up to 27 participants will be enrolled and 3 dose levels will be evaluated in a dose escalation format.

What is the current status of trial NCT02416622?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2015-05. Estimated completion is 2023-05-09.

What conditions does trial NCT02416622 study?

This clinical trial studies the following conditions: X-linked Retinoschisis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02416622?

The interventions under investigation include: rAAV2tYF-CB-hRS1 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02416622?

This trial is sponsored by Beacon Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02416622 being conducted?

This trial has 9 study locations across California, Florida, Maryland, Massachusetts, Michigan. 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