Actively Recruiting

All Genders
NCT05809635

Study of BEST1 Vitelliform Macular Dystrophy

Led by Columbia University · Updated on 2025-07-30

52

Participants Needed

3

Research Sites

269 weeks

Total Duration

On this page

Sponsors

C

Columbia University

Lead Sponsor

U

Universität Tübingen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Study of BEST1 Vitelliform Macular Dystrophy

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to provide informed consent
  • Diagnosis of BEST1-associated Vitelliform Macular Dystrophy by a trained retinal specialist
  • Must be able to commit to 4 follow-up study visits over 3 years
Not Eligible

You will not qualify if you...

  • Presence of any systemic condition that prevents undergoing the exams

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Columbia University Irving Medical Center

New York, New York, United States, 10032

Actively Recruiting

2

Institut de la Vision/Centre de maladies rares du Centre Hospitalier National Ophtalmologique des Quinze-Vingts

Paris, France

Not Yet Recruiting

3

Eberhard Karls University Tubingen

Tübingen, Germany

Actively Recruiting

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Research Team

S

Stephen H Tsang, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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