Evaluation of Tonabersat for DME

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

May 2, 2023

Primary Completion Date

June 27, 2025

Study Completion Date

November 30, 2025

Conditions
Diabetic Macular Edema
Interventions
DRUG

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.

OTHER

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.

Trial Locations (28)

13088

Retina-Vitreous Surgeons of Central NY, PC, Liverpool

15143

Pittsburg Clinical Trial Consortium, Sewickley

19104

The Trustees of the University of Pennsylvania, Philadelphia

21237

Elman Retina Group, Baltimore

29926

Hilton Head Retina Institute, Hilton Head Island

30328

Thomas Eye Group, Sandy Springs

30909

Southeast Retina Center, Augusta

32209

University of Florida- Jacksonville, Jacksonville

33782

Southeast Eye Institute, P.A. dba Eye Associates of Pinellas, Pinellas Park

33805

Central Florida Retina Institute, Lakeland

Florida Retina Consultants, Lakeland

33912

National Ophthalmic Research Institute, Fort Myers

46290

Midwest Eye Institute, Indianapolis

55905

Mayo Clinic, Rochester

60304

Illinois Retina Associates, Oak Park

63128

Retina Research Institute, LLC, St Louis

71291

Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana, West Monroe

77401

Retina Consultants of Texas, PA, Bellaire

78240

Retinal Consultants of Texas, San Antonio

79424

Texas Retina Associates, Lubbock

90503

Macula Retina Vitreous Institute, Torrance

92211

Southern California Desert Retina Consultants, Inc., Palm Desert

92354

Loma Linda University, Loma Linda

92647

Retina Associates of Southern California, Huntington Beach

94609

East Bay Retina Consultants, Inc., Oakland

97401

Verum Research LLC, Eugene

02118

Boston Medical Center Corporation, Boston

02215

Joslin Diabetes Center, Boston

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

National Eye Institute (NEI)

NIH

collaborator

Juvenile Diabetes Research Foundation

OTHER

lead

Jaeb Center for Health Research

OTHER