NCT05727891

Evaluation of Tonabersat for DME

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-02
• Primary completion: 2025-06-27
• Completion: 2026-01-01
• First posted: 2023-02-14
• Last updated: 2025-12-11

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study