New eye injection shows promise for Diabetes-Related vision loss
NCT ID NCT06908876
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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150 people
The number who actually took part.
- Started
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Apr 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Shanghai General hospital
Shanghai, Shanghai Municipality, 200080, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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