Evaluation of Tonabersat for DME (AN)

April 18, 2024 updated by: Jaeb Center for Health Research

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Cynthia Stockdale, MSPH
  • Phone Number: 8139758690
  • Email: DRCRNET@JAEB.ORG

Study Locations

  • United States
    • California
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • Retina Associates Of Southern California
        • Contact:
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University
        • Contact:
      • Oakland, California, United States, 94609
        • Recruiting
        • East Bay Retina Consultants, Inc.
        • Contact:
      • Palm Desert, California, United States, 92211
        • Recruiting
        • Southern California Desert Retina Consultants, Inc.
        • Contact:
      • Torrance, California, United States, 90503
        • Recruiting
        • Macula Retina Vitreous Institute
        • Contact:
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • National Ophthalmic Research Institute
        • Contact:
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida- Jacksonville
        • Contact:
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Florida Retina Consultants
        • Contact:
      • Lakeland, Florida, United States, 33805
        • Not yet recruiting
        • Central Florida Retina Institute
        • Contact:
          • Scott M. Friedman, M.D.
          • Phone Number: 863-682-7474
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Recruiting
        • Southeast Retina Center
        • Contact:
      • Sandy Springs, Georgia, United States, 30328
        • Recruiting
        • Thomas Eye Group
        • Contact:
    • Illinois
      • Oak Park, Illinois, United States, 60304
        • Recruiting
        • Illinois Retina Associates
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Recruiting
        • Midwest Eye Institute
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • Elman Retina Group
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center Corporation
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Retina Research Institute, LLC
        • Contact:
    • New York
      • Liverpool, New York, United States, 13088
        • Recruiting
        • Retina-Vitreous Surgeons of Central NY, PC
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Sewickley, Pennsylvania, United States, 15143
        • Recruiting
        • Pittsburg Clinical Trial Consortium
        • Contact:
    • South Carolina
      • Hilton Head Island, South Carolina, United States, 29926
        • Recruiting
        • Hilton Head Retina Institute
        • Contact:
    • Texas
      • Lubbock, Texas, United States, 79424
        • Recruiting
        • Texas Retina Associates
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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.
Active Comparator: Tonabersat (80 mg)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in central subfield thickness
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in retinal volume from baseline
Time Frame: 6 months
6 months
Mean change in visual acuity from baseline
Time Frame: 6 months
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
Time Frame: 6 months
Composite outcome, gender-specific spectral domain optical coherence tomography equivalent of 250 µm on Zeiss Stratus optical coherence tomography
6 months
Percentage of eyes receiving other treatment for DME prior to the 6 month visit
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

Juvenile Diabetes Research Foundation
National Eye Institute (NEI)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 14, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRCR Protocol AN
  • UG1EY014231 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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