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Safety and Efficacy Trial of AAV Gene Therapy in Patients With CNGA3 Achromatopsia (A Clarity Clinical Trial)
NCT02935517 · View on ClinicalTrials.gov ↗
Study Summary
This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of AGTC-402, administered to one eye by subretinal injection in individuals with achromatopsia caused by mutations in the CNGA3 gene. The primary study endpoint will be safety and the secondary study endpoint will be efficacy.
Conditions Studied
Interventions
- BIOLOGICAL AGTC-402
Study Locations (6)
Florida
- VitreoRetinal Associates — Gainesville
- Bascom Palmer Eye Institute — Miami
Massachusetts
- Massachusetts Eye and Ear Infirmary — Boston
Ohio
- Cincinnati Eye Institute — Cincinnati
Oregon
- Casey Eye Institute, Oregon Health and Sciences University — Portland
Other
- Hadassah-Hebrew University Medical Center — Jerusalem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-08-03 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02935517
The ClinicalTrials.gov registry entry for NCT02935517 describes a study currently listed as active not recruiting. 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 24 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 Achromatopsia appearing as the primary indexed condition, and to 1 intervention — of which AGTC-402 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: NCT02935517 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Florida, Massachusetts, Ohio. 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 NCT02935517 about?
NCT02935517 is a clinical study titled "Safety and Efficacy Trial of AAV Gene Therapy in Patients With CNGA3 Achromatopsia (A Clarity Clinical Trial)". This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of AGTC-402, administered to one eye by subretinal injection in individuals with achromatopsia caused by mutations in the CNGA3 gene. The primary study endpoint will be safety and the secondary study endpoint will ...
What is the current status of trial NCT02935517?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-08-03. Estimated completion is 2026-08.
What conditions does trial NCT02935517 study?
This clinical trial studies the following conditions: Achromatopsia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02935517?
The interventions under investigation include: AGTC-402 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02935517?
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 NCT02935517 being conducted?
This trial has 6 study locations across Florida, Massachusetts, Ohio, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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