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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05727891
Other study ID # DRCR Protocol AN
Secondary ID UG1EY014231
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 2, 2023
Est. completion date May 2025

Study information

Verified date June 2024
Source Jaeb Center for Health Research
Contact Cynthia Stockdale, MSPH
Phone 8139758690
Email DRCRNET@JAEB.ORG
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 128
Est. completion date May 2025
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria 1. Adults with type 1 or 2 diabetes mellitus 2. 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 3. Media clarity, pupillary dilation, and study participant cooperation sufficient for adequate OCT Key Exclusion Criteria - Macular edema is considered to be due to a cause other than DME - Major ocular surgery within prior 4 months, or anticipated after randomization - History of focal/grid laser or other ocular surgical, intravitreal, or peribulbar treatment for DR or DME within prior 1 year, and no more than 4 anti-VEGF injections within prior 3 years - Anticipated need to treat DME or DR during the first 6 months, or anticipated need for cataract surgery during study period - Any history of vitrectomy - Systemic anti-VEGF or pro-VEGF treatment within 12 months prior to randomization - History of chronic renal failure requiring dialysis or kidney transplant - History of moderate to severe hepatic impairment, including known liver function test (LFT) values > 3x's the upper limit of normal

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Southeast Retina Center Augusta Georgia
United States Elman Retina Group Baltimore Maryland
United States Boston Medical Center Corporation Boston Massachusetts
United States Joslin Diabetes Center Boston Massachusetts
United States Verum Research LLC Eugene Oregon
United States National Ophthalmic Research Institute Fort Myers Florida
United States Hilton Head Retina Institute Hilton Head Island South Carolina
United States Retina Associates of Southern California Huntington Beach California
United States Midwest Eye Institute Indianapolis Indiana
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 Retina-Vitreous Surgeons of Central NY, PC Liverpool New York
United States Loma Linda University Loma Linda California
United States Texas Retina Associates Lubbock Texas
United States Illinois Retina Associates Oak Park Illinois
United States East Bay Retina Consultants, Inc. Oakland California
United States Southern California Desert Retina Consultants, Inc. Palm Desert California
United States The Trustees of the University of Pennsylvania Philadelphia Pennsylvania
United States Southeast Eye Institute, P.A. dba Eye Associates of Pinellas Pinellas Park Florida
United States Mayo Clinic Rochester Minnesota
United States Retina Research Institute, LLC Saint Louis Missouri
United States Thomas Eye Group Sandy Springs Georgia
United States Pittsburg Clinical Trial Consortium Sewickley Pennsylvania
United States Macula Retina Vitreous Institute Torrance California

Sponsors (4)

Lead Sponsor Collaborator
Jaeb Center for Health Research Juvenile Diabetes Research Foundation, National Eye Institute (NEI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in central subfield thickness 6 months
Secondary Mean change in retinal volume from baseline 6 months
Secondary Percentage of eyes central subfield thickness below optical coherence machine- and sex-specific threshold for DME and at least a 10% decrease from baseline Composite outcome, gender-specific spectral domain optical coherence tomography equivalent of 250 µm on Zeiss Stratus optical coherence tomography 6 months
Secondary Mean change in visual acuity from baseline 6 months
Secondary Percentage of eyes receiving other treatment for DME prior to the 6 month visit 6 months
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