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Can one shot in the eye treat diabetic macular edema?

NCT ID NCT07817121

Disease control Sponsor: Surrozen Operating, Inc. 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing an experimental antibody called SZN-8141 in people with diabetic macular edema, a swelling of the retina that can blur vision. About nine participants will each receive a single injection of SZN-8141 into the eye, with small groups getting increasing doses. The trial tracks side effects, how the body processes the drug, and changes in vision and retinal thickness over roughly three months. This first-in-human study focuses on safety and early biological activity, not on proving the treatment works.

What this could mean

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

Active substance
an experimental antibody called SZN-8141, given as a single injection into the eye
What this could lead to
If it works, this could point toward a new kind of eye injection for diabetic macular edema, possibly given less often than current treatments.
What could go wrong
This is a first-in-human trial with only about nine participants, so it can only show early safety signals, not whether the drug actually helps vision. Eye injections carry risks such as infection, bleeding, and inflammation, and the body may develop antibodies against the drug.

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

About 9 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 90 years

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: * Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity * Age ≥18 years and ≤90 years old * Documented diagnosis of diabetes mellitus (type 1 or 2), as defined by the American Diabetes Association or per World Health Organization (WHO) criteria * Hemoglobin A1C (HbA1c) of ≤12% for ≤60 days before Day 1 * Macular thickening secondary to DME involving the center of the fovea with CST ≥325 μm on OCT as determined by the central reading center at the screening visit * Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images * BCVA of 73-25 ETDRS letters inclusive (20/40-20/200 approximate Snellen equivalent), using the ETDRS protocol at the initial testing distance of 4 m on Day 1 * Treatment naïve and previously treated participants with protocol specified drug washout Exclusion Criteria: * Be pregnant or breastfeeding * Active cancer within the past 12 months * Stroke (cerebral vascular accident) or myocardial infarction \<6 months before Day 1 * High risk proliferative diabetic retinopathy (PDR) in the study eye * Any treatment with panretinal photocoagulation or macular laser in the study eye * Any history of idiopathic or immune-mediated uveitis in either eye * Active ocular inflammation or suspected or active ocular or periocular infection in either eye on Day 1 * History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or intraocular glaucoma surgery in the study eye * Any planned surgery in the study eye during the course of the study * Uncontrolled glaucoma * Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis, or anticipated to require hemodialysis or peritoneal dialysis at any time during the trial Other inclusion and exclusion criteria may apply.

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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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

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

    Open the record ↗

  3. 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.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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