Natural History Study in Retinitis Pigmentosa Caused by Mutations in the BEST1 Gene

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The purpose of this study is to establish the natural history of of participants with BESTROPHIN 1 Vitelliform Macular Dystrophy. The blinding disorder Best Vitelliform Macular Dystrophy (VMD) is caused by any one of more than 250 different mutations in the BEST1 gene. As new treatments are developed, a clear understanding of the natural history of disease progression of BEST1 VMD is necessary. The goals of this natural history study are to: 1. Report the natural history of retinal degeneration in participants with a clinical diagnosis of VMD with molecular confirmation of a pathogenic BEST1 mutation(s). 2. Identify sensitive structural and functional outcome measures to use for future multicenter clinical trials for the treatment of BESTROPHIN 1 VMD. 3. Compare progression of the identified structural and functional measures between the two eyes to judge the suitability of the second untreated eye as a control for a future clinical trial involving unilateral treatment 4. Identify well-defined patient populations for future clinical trials of investigative treatments for BEST1 VMD.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Ability to provide informed consent

• Diagnosis of BEST1-associated VMD by study physician, who are trained retinal specialists in the university clinic Must be able to commit to 4 follow-up study visits (3 years)

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Other Locations
France
Institut de la Vision/Centre de maladies rares du Centre Hospitalier National Ophtalmologique des Quinze-Vingts
NOT_YET_RECRUITING
Paris
Germany
Eberhard Karls University Tubingen
RECRUITING
Tübingen
Contact Information
Primary
Stephen H Tsang, MD, PhD
sht2@cumc.columbia.edu
212-342-1186
Time Frame
Start Date: 2021-03-30
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 52
Treatments
Best Vitelliform Macular Dystrophy (VMD) Participants
Participants with a clinical picture of Retinitis pigmentosa with dominant and recessive variants in the BEST1 gene
Sponsors
Leads: Columbia University
Collaborators: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, National Eye Institute (NEI), Universität Tübingen

This content was sourced from clinicaltrials.gov