Status:
COMPLETED
Safety and Efficacy of Emixustat in Stargardt Disease
Lead Sponsor:
Kubota Vision Inc.
Collaborating Sponsors:
Food and Drug Administration (FDA)
Conditions:
Stargardt Disease
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if emixustat hydrochloride reduces the rate of progression of macular atrophy compared to placebo in subjects with Stargardt disease. Funding Source -- FDA O...
Detailed Description
Stargardt disease is a rare, inherited degenerative disease of the retina affecting approximately 1 in 8000 to 10 000 people and is the most common type of hereditary macular dystrophy. There are no a...
Eligibility Criteria
Inclusion
- A clinical diagnosis of macular atrophy secondary to Stargardt disease (STGD)
- Macular atrophy measured to fall within a defined size range
- Two mutations of the ABCA4 gene. If only one mutation, a typical STGD appearance of the retina.
- Visual acuity in the study eye of at least 20/320
Exclusion
- Macular atrophy secondary to a disease other than STGD
- Mutations of genes, other than ABCA4, that are associated with retinal degeneration
- Surgery in the study eye in the past 3 months
- Prior participation in a gene therapy or stem cell clinical trial for STGD
- Recent participation in a clinical trial for STGD evaluating a complement inhibitor or vitamin A derivative
- Use of certain medications in the past 4 weeks that might interfere with emixustat
- An abnormal electrocardiogram (ECG)
- Certain abnormalities on laboratory blood testing
- Female subjects who are pregnant or nursing
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2022
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT03772665
Start Date
January 7 2019
End Date
June 23 2022
Last Update
May 30 2024
Active Locations (29)
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1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
2
UCSF Dept. of Ophthalmology
San Francisco, California, United States, 94143-0730
3
Emory University
Atlanta, Georgia, United States, 30322
4
The Wilmer Eye Institute Johns Hopkins University
Baltimore, Maryland, United States, 21287