Safety and Efficacy of Emixustat in Stargardt Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Stargardt Disease

In brief

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 OOPD

Key facts

Study ID

NCT03772665

Run by

Kubota Vision Inc.

People needed

194

Starts

2019-01-07

Expected to finish

2022-06-23

Last updated by the study team

2024-05-30

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• UCSF Dept. of Ophthalmology — San Francisco, California, United States
• Emory University — Atlanta, Georgia, United States
• The Wilmer Eye Institute Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan Kellogg Eye Center — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Duke Eye Center — Durham, North Carolina, United States
• Casey Eye Institute - OHSU — Portland, Oregon, United States
• Retina Foundation of the Southwest — Dallas, Texas, United States
• University of Utah John Moran Eye Center — Salt Lake City, Utah, United States
• Medical College of Wisconsin-Eye Institute — Milwaukee, Wisconsin, United States
• Santa Casa de Misericórdia de Belo Horizonte — Belo Horizonte, Minas Gerais, Brazil
• Hospital Sao Paulo — São Paulo, Brazil
• The Hospital for Sick Children — Toronto, Ontario, Canada
• Rigshospitalet-Glostrup — Glostrup Municipality, Capital Region, Denmark
• Service D'Ophtalmologie Chi Creteil — Créteil, Île-de-France Region, France
• CHNO Quinze-Vingts - CIC — Paris, Île-de-France Region, France
• Universitätsklinikum Tübingen, Department für Augenheilkunde — Tübingen, Baden-Wurttemberg, Germany
• Universitäts-Augenklinik Bonn — Bonn, Germany
• AOU Università della Campania Luigi Vanvitelli — Naples, Campania, Italy
• Università Cattolica del Sacro Cuore - Fondazione Policlinico Gemelli — Rome, Lazio, Italy
• IRCCS Ospedale San Raffaele — Milan, Lombardy, Italy
• UOC Oculistica Asst Fatebene Pratelli Sacco Universita delgi Studi di Milano — Milan, Lombardy, Italy
• SODC di Oculistica AOU Careggi — Florence, Tuscany, Italy
• Radboud University Medical Center — Nijmegen, Gelderland, Netherlands

Full record on ClinicalTrials.gov

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