Tonabersat for Diabetic Macular Edema
(AN Trial)

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Jaeb Center for Health Research

Prior Safety Data

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.

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)

+2 more

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.

+5 more

Participant Groups

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.

2Treatment groups

Active Control

Placebo Group

Group I: Tonabersat (80 mg)Active Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention