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New pill could fight diabetic eye swelling

NCT ID NCT05727891

Disease control Sponsor: Jaeb Center for Health Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether the oral drug tonabersat can reduce retinal swelling in people with diabetic macular edema who still have good vision. About 128 adults with type 1 or 2 diabetes will take either tonabersat or a placebo daily for several months. The main goal is to see if the drug decreases the thickness of the central retina, a key sign of fluid buildup.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tonabersat (80 mg pill taken once daily)
What this could lead to
If it works, tonabersat could offer a new oral treatment option to reduce retinal swelling in people with diabetic macular edema who still have good vision.
What could go wrong
This is an early Phase 2 trial with only 128 participants, so results may not apply to everyone. The primary outcome is a measure of retinal thickness, not vision improvement, and the drug may not show meaningful benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema

Contacts and locations

Locations

  • Boston Medical Center Corporation

    Boston, Massachusetts, 02118, United States

  • Central Florida Retina Institute

    Lakeland, Florida, 33805, United States

  • East Bay Retina Consultants, Inc.

    Oakland, California, 94609, United States

  • Elman Retina Group

    Baltimore, Maryland, 21237, United States

  • Florida Retina Consultants

    Lakeland, Florida, 33805, United States

  • Hilton Head Retina Institute

    Hilton Head Island, South Carolina, 29926, United States

  • Illinois Retina Associates

    Oak Park, Illinois, 60304, United States

  • Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana

    West Monroe, Louisiana, 71291, United States

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

  • Loma Linda University

    Loma Linda, California, 92354, United States

  • Macula Retina Vitreous Institute

    Torrance, California, 90503, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Midwest Eye Institute

    Indianapolis, Indiana, 46290, United States

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912, United States

  • Pittsburg Clinical Trial Consortium

    Sewickley, Pennsylvania, 15143, United States

  • Retina Associates of Southern California

    Huntington Beach, California, 92647, United States

  • Retina Consultants of Texas, PA

    Bellaire, Texas, 77401, United States

  • Retina Research Institute, LLC

    St Louis, Missouri, 63128, United States

  • Retina-Vitreous Surgeons of Central NY, PC

    Liverpool, New York, 13088, United States

  • Retinal Consultants of Texas

    San Antonio, Texas, 78240, United States

  • Southeast Eye Institute, P.A. dba Eye Associates of Pinellas

    Pinellas Park, Florida, 33782, United States

  • Southeast Retina Center

    Augusta, Georgia, 30909, United States

  • Southern California Desert Retina Consultants, Inc.

    Palm Desert, California, 92211, United States

  • Texas Retina Associates

    Lubbock, Texas, 79424, United States

  • The Trustees of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Thomas Eye Group

    Sandy Springs, Georgia, 30328, United States

  • University of Florida- Jacksonville

    Jacksonville, Florida, 32209, United States

  • Verum Research LLC

    Eugene, Oregon, 97401, United States

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