A Phase 2 Evaluation of Tonabersat for Diabetic Macular Edema (Protocol AN)

Status: Active_not_recruiting
Location: See all (28) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults with type 1 or 2 diabetes mellitus

• At least one eye with:

‣ Best corrected E-ETDRS visual acuity letter score ≥ 74 (i.e., 20/32 or better)

⁃ Ophthalmoscopic evidence of center-involved DME in study eye confirmed by central subfield thickness on spectral domain OCT

⁃ Zeiss Cirrus: ≥ 290 µm in females, ≥ 305 µm in males

⁃ Heidelberg Spectralis: ≥ 305 µm in females, ≥ 320 µm in males

∙ Recruitment will be monitored with a goal to have equal proportions in the following categories above the CI-DME thresholds: \<75 μm, 75 μm to \<175 μm, ≥175 μm

• Media clarity, pupillary dilation, and study participant cooperation sufficient for adequate OCT

Locations
United States
California
Retina Associates of Southern California
Huntington Beach
Loma Linda University
Loma Linda
East Bay Retina Consultants, Inc.
Oakland
Southern California Desert Retina Consultants, Inc.
Palm Desert
Macula Retina Vitreous Institute
Torrance
Florida
National Ophthalmic Research Institute
Fort Myers
University of Florida- Jacksonville
Jacksonville
Central Florida Retina Institute
Lakeland
Florida Retina Consultants
Lakeland
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park
Georgia
Southeast Retina Center
Augusta
Thomas Eye Group
Sandy Springs
Illinois
Illinois Retina Associates
Oak Park
Indiana
Midwest Eye Institute
Indianapolis
Louisiana
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe
Massachusetts
Boston Medical Center Corporation
Boston
Joslin Diabetes Center
Boston
Maryland
Elman Retina Group
Baltimore
Minnesota
Mayo Clinic
Rochester
Missouri
Retina Research Institute, LLC
St Louis
New York
Retina-Vitreous Surgeons of Central NY, PC
Liverpool
Oregon
Verum Research LLC
Eugene
Pennsylvania
The Trustees of the University of Pennsylvania
Philadelphia
Pittsburg Clinical Trial Consortium
Sewickley
South Carolina
Hilton Head Retina Institute
Hilton Head Island
Texas
Retina Consultants of Texas, PA
Bellaire
Texas Retina Associates
Lubbock
Retinal Consultants of Texas
San Antonio
Time Frame
Start Date: 2023-05-02
Completion Date: 2025-11
Participants
Target number of participants: 128
Treatments
Placebo_comparator: Placebo
Active_comparator: Tonabersat (80 mg)
Sponsors
Collaborators: Juvenile Diabetes Research Foundation, National Institutes of Health (NIH), National Eye Institute (NEI)
Leads: Jaeb Center for Health Research

This content was sourced from clinicaltrials.gov

Similar Clinical Trials