Tonabersat for Diabetic Macular Edema

(AN Trial)

Recruiting at 27 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

128 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Eligibility Criteria

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.

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

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

Exclusion Criteria

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

I've had treatments for diabetic eye issues but no more than 4 anti-VEGF injections.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+