Natural History Study
OtherLongitudinal assessment of participants with BEST1 Vitelliform Macular Dystrophy
NCT Number: NCT05809635
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.
Interested in participating?
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Observational
Institut de la Vision/Centre de maladies rares du Centre Hospitalier National Ophtalmologique des Quinze-Vingts, Paris, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Longitudinal assessment of participants with BEST1 Vitelliform Macular Dystrophy
Time frame: Up to 3 years
Time frame: Up to 3 years
ERG conducted under International Society for Clinical Electrophysiology of Vision (ISCEV) Protocol.
Time frame: Up to 3 years
EOG conducted under International Society for Clinical Electrophysiology of Vision (ISCEV) Protocol
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Time frame: Up to 3 years
Contact information is provided by the study sponsor or research team.
Columbia University
Other
Natural History Study in Retinitis Pigmentosa Caused by Mutations in the BEST1 Gene
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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