Tonabersat for Diabetic Macular Edema

(AN Trial)

Not currently recruiting at 28 trial locations

Overseen By Cynthia Stockdale, MSPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jaeb Center for Health Research

Must not be taking: Systemic anti-VEGF

Disqualifiers: Ocular surgery, Vitrectomy, Renal failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tonabersat to determine its effectiveness for diabetic macular edema (DME), a condition where fluid accumulates in the eye, affecting vision. The goal is to see if tonabersat can reduce retinal thickness more effectively than a placebo, particularly in individuals who still have good eyesight. Participants should have type 1 or 2 diabetes and signs of DME in at least one eye, but they should not have undergone recent major eye surgery or other specific treatments for DME. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic anti-VEGF or pro-VEGF treatments, you must have stopped them at least 12 months before joining the trial.

Is there any evidence suggesting that tonabersat is likely to be safe for humans?

Research has shown that tonabersat can cause side effects such as headaches, sleepiness, and dizziness. Studies that assessed the treatment's safety noted these side effects. Tonabersat's progression to a Phase 2 trial indicates it has passed initial safety tests in earlier studies, suggesting it is considered safe enough for further testing in people. However, as with any treatment, risks may still exist. Prospective participants should discuss any side effects with the research team before joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic macular edema?

Tonabersat is unique because it offers a new approach to treating diabetic macular edema by targeting gap junctions, which are channels that allow cells to communicate with each other. Unlike current treatments like anti-VEGF injections and corticosteroids, which primarily focus on reducing fluid leakage and inflammation in the eye, tonabersat aims to directly modulate the cellular communication that contributes to the disease. This new mechanism of action has researchers excited as it could provide an alternative for patients who do not respond well to existing therapies or who experience side effects.

What evidence suggests that tonabersat might be an effective treatment for diabetic macular edema?

Research has shown that tonabersat, which participants in this trial may receive, might help with diabetic macular edema (DME). Animal studies and early lab tests suggest that tonabersat reduces inflammation, potentially lessening eye swelling. This is important because swelling can impair vision. Although research in humans is ongoing, these early findings offer hope that tonabersat could effectively treat diabetes-related eye problems. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for adults with type 1 or 2 diabetes who have diabetic macular edema (DME) affecting the center of their retina but still have good vision (20/25 or better). Participants must meet specific criteria based on retinal thickness measurements. They shouldn't have had certain eye treatments in the past year, need upcoming major eye surgery, or suffer from severe kidney or liver conditions.

Inclusion Criteria

My eye scan shows swelling in the center of my retina due to diabetes.

At least one eye with best corrected E-ETDRS visual acuity letter score ≥ 79 (i.e., 20/25 or better)

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

Exclusion Criteria

I have had surgery to remove the vitreous gel from my eye.

I haven't taken any VEGF-targeting drugs in the last year.

I have chronic kidney failure and need dialysis or have had a kidney transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tonabersat or placebo to assess effects on central subfield thickness in eyes with CI-DME

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tonabersat

Trial Overview The study tests Tonabersat against a placebo to see if it can reduce the thickness in the central part of the retina in patients with DME and good visual acuity. Patients are randomly assigned to receive either Tonabersat or a placebo, without choosing which one they get.

How Is the Trial Designed?

Group I: Tonabersat (80 mg) Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. breakthrought1d.org breakthrought1d.org/grants/united-states/florida/a-phase-2-study-evaluating-short-term-efficacy-of-tonabersat-xiflam-for-diabetic-macular-edema/

A Phase 2 Study Evaluating Short-Term Efficacy of ... Data from animal models and preclinical studies suggest that tonabersat is likely to have a beneficial effect on DR and DME through blocking inflammatory ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05727891

NCT05727891 | Evaluation of Tonabersat for DME This randomized clinical trial will evaluate the effect of tonabersat compared with placebo on central subfield thickness (CST) in eyes with center-involved ...

3. public.jaeb.org public.jaeb.org/drcrnet/stdy/588

DRCR Retina Network - Public Site This randomized clinical trial will evaluate the effect of tonabersat compared with placebo on central subfield thickness (CST) in eyes with center-involved DME ...

4. trialx.com trialx.com/clinical-trials/listings/275192/evaluation-of-tonabersat-for-dme/

Evaluation of Tonabersat for DME This randomized clinical trial will evaluate the effect of tonabersat compared with placebo on central subfield thickness (CST) in eyes with center-involved ...

5. s3.amazonaws.com s3.amazonaws.com/publicfiles.jaeb.org/drcrnet/protocol/DRCR_Protocol_AN_Tonabersat_v4.pdf

DRCR Retina Network A Phase 2 Evaluation of Tonabersat ... A Phase 2 Evaluation of Tonabersat for Diabetic Macular Edema. (DME) ... tonabersat treatment leads to improvement of renal outcomes in diabetes.