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New eye injection shows promise for Diabetes-Related vision loss

NCT ID NCT06908876

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new eye injection called IBI302 for people with diabetic macular edema, a condition that causes vision loss due to diabetes. About 150 adults aged 18-80 with type 1 or 2 diabetes and swelling in the center of the retina will receive either IBI302 or an active control. The main goal is to see if IBI302 improves vision and reduces eye swelling over 16 weeks.

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

150 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Feb 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 80 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: * Informed Consent Form (ICF) must be signed before participating in the study, compliance is good, and willing to complete the visit as planned; * Subjects aged 18-80 years (inclusive) at the time of screening, and diagnosed with type I or type II diabetes; * DME involved the macular fovea at screening; * CST≥320 μm as confirmed by OCT in the study eye at screening. * At baseline, visual acuity loss in the study eye due to DME with BCVA ranging from 19 to 78 ETDRS letters (inclusive); * Currently use of insulin, or other injectable drugs, or oral hypoglycemic agents to treat diabetes, HbA1c ≤10% at screening; Exclusion criteria: Eye disease * High-risk PDR in the study eye; * Dense hard exudation that destroyed the fovea structure of the macula in the study eye; * Iris neovascularization in the study eye; * Other systemic/ocular disease associated with the study eye may cause subjects fail to respond to study treatment or confuse the interpretation of study findings; * Uncontrolled glaucoma in the study eye; Eye treatment * Any previous treatment with IBI302 in the study eye before baseline; * Intravitreal injection of anti-VEGF or anti-complement agents in the study eye within 90 days prior to baseline; * Panretinal photocoagulation or macular laser (focal, grid or micropulse) in the study eye within 90 days prior to baseline; * Cataract surgery was performed in the study eye within 90 days prior to baseline; * YAG laser capsulotomy or YAG laser peripheral iridotomy were performed in the study eye within 90 days prior to baseline. * Any other intraocular surgery (eg, corneal transplantation, glaucoma filtration, pars plana vitrectomy, or radiotherapy) Systemic diseases/treatments * Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable antidiabetic medication \<90 days prior to administration. * Uncontrolled hypertension. * Systemic use of anti-VEGF or anti-complement agents within 90 days prior to baseline * The presence of any other pre-existing disease, metabolic disorder, abnormal results on a physical examination or clinical laboratory examination that may reasonably be suspected of causing contraindications with the investigational drug, or affecting the interpretation of study results, or placing subjects at high risk of treatment complications (e.g., coagulation dysfunction, history of acute cardiovascular and cerebrovascular disease, history of treated or untreated malignancies within the past 5 years, etc.); * Systemic treatment for suspected or active systemic infection (e.g., tuberculosis, hepatitis B, hepatitis C, etc.); * Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Shanghai General hospital

    Shanghai, Shanghai Municipality, 200080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.