Safety and Efficacy Trial of AAV Gene Therapy in Patients With CNGB3 Achromatopsia (A Clarity Clinical Trial)
Status unconfirmed · Phase 1/Phase 2
Conditions studied: Achromatopsia
In brief
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.
Key facts
- Study ID
- NCT02599922
- Run by
- Beacon Therapeutics
- People needed
- 32
- Starts
- 2016-04-11
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2022-07-22
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- VitreoRetinal Associates — Gainesville, Florida, United States
- Bascom Palmer Eye Institute — Miami, Florida, United States
- Pangere Center for Inherited Retinal Diseases, The Chicago Lighthouse for People Who Are Blind or Visually Imp — Chicago, Illinois, United States
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Duke Eye Center, Duke University Medical Center — Durham, North Carolina, United States
- Cincinnati Eye Institute — Cincinnati, Ohio, United States
- Casey Eye Institute, Oregon Health and Sciences University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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