Gene therapy injection aims to ease diabetic eye swelling

NCT ID NCT07362927

Disease control Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a gene therapy called LX111 for diabetic macular edema (DME), a condition that causes vision loss due to swelling in the retina. About 32 adults with DME will receive a single injection into the eye. The main goals are to check safety and see if it helps improve vision and reduce swelling.

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Study facts

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

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 32 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Sep 2031

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.

Inclusion Criteria: 1. Willing to sign the informed consent, and willing to attend follow-up visits; 2. Age ≥ 18; 3. Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea; 4. CST ≥ 300 μm in the study eye at Screening; 5. BCVA ETDRS letters between 19 and 73; 6. Participants must have received anti-VEGF therapy within 12 months prior to screening and demonstrated a meaningful response; 7. Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up. Exclusion Criteria: 1. Active proliferative diabetic retinopathy (PDR); 2. Presence of iris neovascularization in the study eye at Screening; 3. Retinal laser photocoagulation in the study eye within 3 months prior to Screening; 4. Prior gene therapy in the study eye; 5. The study eye has been treated with an intravitreal dexamethasone implant (Ozurdex®) within 6 months prior to Screening. 6. Systemic anti-VEGF treatment within 3 months before Screening; 7. Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to Screening;

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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 (DME)

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Gene therapy injection aims to ease diabetic eye swelling

What the study statuses mean