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Can a single gene therapy injection ease diabetic macular edema?

NCT ID NCT06237777

Disease control Sponsor: Wang Min 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This phase 1 trial tests an experimental gene therapy called SKG0106, given as an injection into the eye, for people with diabetic macular edema, a complication of diabetes that causes blurred vision. The study enrolls a small group of adults with type 1 or type 2 diabetes whose vision loss is mainly due to swelling in the center of the retina. Researchers evaluate the safety of three dose levels and look for early signs that the treatment improves visual acuity and reduces retinal swelling.

What this could mean

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

Active substance
SKG0106, a gene therapy injected into the eye
What this could lead to
If it works, this could lead to a one-time treatment that reduces the need for frequent eye injections in people with diabetic macular edema.
What could go wrong
This is an early, small trial focused on safety, so it may not show clear benefit. Risks include eye inflammation, vision decline, or bleeding inside the eye.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

3 people

The number who actually took part.

Started

Jun 2024

Finished

Jul 2025

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: * Written informed consent must be obtained prior to all assessments. * Age ≥18 years at screening. * Type 1 or type 2 diabetes mellitus at screening. * Study eye criteria: * Decreased visual acuity attributable primarily to DME. * DME involves the macular center. Exclusion Criteria: * Active proliferative diabetic retinopathy in the study eye. * Any current or previous ocular disease in the study eye other than DME that could interfere with macular evaluation or affect central vision at screening or baseline. * Any active intraocular or periocular infection or active intraocular inflammation of the study eye at screening or baseline. * History of idiopathic or autoimmune uveitis in the study eye at screening or baseline. * Prior gene therapy in either eye. * History of vitreoretinal surgery in the study eye. * Uncontrolled blood pressure at screening or baseline defined as systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg. * History of treated or untreated malignancy of any organ system within the past 5 years. * Pregnant or lactating women. * Women of reproductive age, defined as all women who are biologically capable of being pregnant, unless they use highly effective contraceptive methods between the time of study drug administration and 3 months after EOS (end of study).

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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

  • Eye & ENT Hospital of Fudan University

    Shanghai, China

  • Peking Union Medical College Hospital

    Beijing, China

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