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NCT02935517 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy Trial of AAV Gene Therapy in Patients With CNGA3 Achromatopsia (A Clarity Clinical Trial)

A Phase 1 study of Achromatopsia, sponsored by Beacon Therapeutics.

Active
Registry status
Phase 1
Development phase
24
Enrollment target
6
Study locations

NCT02935517: Active Phase 1 study of Achromatopsia, sponsored by Beacon Therapeutics.

NCT02935517 is a Phase 1 study of Achromatopsia that is active but no longer recruiting, run by Beacon Therapeutics. The registered enrollment target is 24 participants, below the 6,696-participant average among 3 other Achromatopsia trials with a reported enrollment target (100% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02935517, a Phase 1 study of Achromatopsia, is active but no longer recruiting, sponsored by Beacon Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
6
Study locations

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

FieldValue
Enrollment Target 24 participants
Start Date 2017-08-03
Est. Completion 2026-08
Phase Phase 1
Beacon Therapeutics

12 total trials

What the registry record for NCT02935517 still lists

NCT02935517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 6,696-participant average among 3 other Achromatopsia trials with a reported enrollment target (100% lower).

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.

NCT02935517 lists 6 locations in 5 states (Florida, Massachusetts, Ohio).

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.

What interventions are being tested in trial NCT02935517?

The interventions under investigation include: AGTC-402 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02935517?

This trial is sponsored by Beacon Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.

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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Source: ClinicalTrials.gov NCT02935517, the US trial registry maintained by the National Library of Medicine. NCT02935517 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.