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NCT02599922 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Trial of AAV Gene Therapy in Patients With CNGB3 Achromatopsia (A Clarity Clinical Trial)
A Phase 1 study of Achromatopsia, sponsored by Beacon Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 8
- Study locations
NCT02599922: Active Phase 1 study of Achromatopsia, sponsored by Beacon Therapeutics.
NCT02599922 is a Phase 1 study of Achromatopsia that is active but no longer recruiting, run by Beacon Therapeutics. The registered enrollment target is 32 participants, below the 6,693-participant average among 3 other Achromatopsia trials with a reported enrollment target (100% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02599922, 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
- 32 participants
- Enrollment target
- 8
- Study locations
Study Summary
This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of AGTC-401 administered to one eye by subretinal injection in individuals with achromatopsia caused by mutations in the CNGB3 gene. The primary study endpoint will be safety and the secondary study endpoint will be efficacy.
Conditions Studied
Interventions
- BIOLOGICAL rAAV2tYF-PR1.7-hCNGB3
Study Locations (8)
Florida
- VitreoRetinal Associates - Gainesville
- Bascom Palmer Eye Institute - Miami
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
- Boston Children's Hospital - Boston
Illinois
- Pangere Center for Inherited Retinal Diseases, The Chicago Lighthouse for People Who Are Blind or Visually Imp - Chicago
North Carolina
- Duke Eye Center, Duke University Medical Center - Durham
Ohio
- Cincinnati Eye Institute - Cincinnati
Oregon
- Casey Eye Institute, Oregon Health and Sciences University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-04-11 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
What the registry record for NCT02599922 still lists
NCT02599922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 6,693-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 rAAV2tYF-PR1.7-hCNGB3 is the first listed.
NCT02599922 lists 8 locations in 6 states (Florida, Massachusetts, Illinois).
Frequently Asked Questions
What is clinical trial NCT02599922 about?
NCT02599922 is a clinical study titled "Safety and Efficacy Trial of AAV Gene Therapy in Patients With CNGB3 Achromatopsia (A Clarity Clinical Trial)". This will be a non-randomized, open-label, Phase 1/2 study of the safety and efficacy of AGTC-401 administered to one eye by subretinal injection in individuals with achromatopsia caused by mutations in the CNGB3 gene. The primary study endpoint will be safety and the secondary study endpoint will b...
What is the current status of trial NCT02599922?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2016-04-11. Estimated completion is 2026-07.
What conditions does trial NCT02599922 study?
This clinical trial studies the following conditions: Achromatopsia.
What interventions are being tested in trial NCT02599922?
The interventions under investigation include: rAAV2tYF-PR1.7-hCNGB3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02599922?
This trial is sponsored by Beacon Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02599922 being conducted?
This trial has 8 study locations across Florida, Illinois, Massachusetts, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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