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Evaluation of Tonabersat for DME
Sponsor: Jaeb Center for Health Research
Summary
This randomized clinical trial will evaluate the effect of tonabersat compared with placebo on central subfield thickness (CST) in eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity.
Official title: A Phase 2 Evaluation of Tonabersat for Diabetic Macular Edema (Protocol AN)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2023-05-02
Completion Date
2026-01
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
Tonabersat
Two pills of Study Drug (80 mg tonabersat) is taken orally once daily. It is recommended the Study Drug be taken at bedtime. The first dose (two pills) will be taken at bedtime on the day the participant is randomized.
Placebo
Two pills of Study Drug (placebo) is taken orally once daily. It is recommended the Study Drug be taken at bedtime. The first dose (two pills) will be taken at bedtime on the day the participant is randomized.
Locations (28)
Retina Associates of Southern California
Huntington Beach, California, United States
Loma Linda University
Loma Linda, California, United States
East Bay Retina Consultants, Inc.
Oakland, California, United States
Southern California Desert Retina Consultants, Inc.
Palm Desert, California, United States
Macula Retina Vitreous Institute
Torrance, California, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
University of Florida- Jacksonville
Jacksonville, Florida, United States
Central Florida Retina Institute
Lakeland, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Thomas Eye Group
Sandy Springs, Georgia, United States
Illinois Retina Associates
Oak Park, Illinois, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana, United States
Elman Retina Group
Baltimore, Maryland, United States
Boston Medical Center Corporation
Boston, Massachusetts, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Retina Research Institute, LLC
St Louis, Missouri, United States
Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York, United States
Verum Research LLC
Eugene, Oregon, United States
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania, United States
Hilton Head Retina Institute
Hilton Head Island, South Carolina, United States
Retina Consultants of Texas, PA
Bellaire, Texas, United States
Texas Retina Associates
Lubbock, Texas, United States
Retinal Consultants of Texas
San Antonio, Texas, United States