Evaluation of Tonabersat for DME
- Conditions
- Diabetic Macular Edema
- Interventions
- Other: Placebo
- Registration Number
- NCT05727891
- Lead Sponsor
- Jaeb Center for Health Research
- Brief 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.
- Detailed Description
The primary objective is to assess the effects of tonabersat, an orally administered Connexin43 hemichannel inhibitor, on central subfield thickness (mean change) compared with placebo in eyes with CI-DME and good visual acuity at 6 months.
Exploratory objectives will evaluate biomarkers of kidney function for potential benefit. Furthermore, this phase 2 study is being conducted to determine whether the conduct of a phase 3 trial has merit and provide information on outcome measures needed to design a phase 3 trial.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 128
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Tonabersat (80 mg) Tonabersat -
- Primary Outcome Measures
Name Time Method Mean change in central subfield thickness 6 months
- Secondary Outcome Measures
Name Time Method Mean change in retinal volume from baseline 6 months Percentage of eyes central subfield thickness below optical coherence machine- and sex-specific threshold for DME and at least a 10% decrease from baseline 6 months Composite outcome, gender-specific spectral domain optical coherence tomography equivalent of 250 µm on Zeiss Stratus optical coherence tomography
Mean change in visual acuity from baseline 6 months Percentage of eyes receiving other treatment for DME prior to the 6 month visit 6 months
Trial Locations
- 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
🇺🇸Saint 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