Evaluating IBI302 for Diabetic Macular Edema

A Randomized, Double-maskedblind, Activity-controlled Phase II Clinical Study to Evaluateing the Efficacy and Safety of Intravitreal Injection of IBI302 in Patients With Diabetic Macular Edema（DME） Subjects

This study is testing a new eye injection called IBI302 to see if it works better than another treatment for people with Diabetic Macular Edema who have vision problems.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06908876 on ClinicalTrials.gov

What this trial studies

This study is a multi-center, randomized, double-masked, active-controlled trial aimed at assessing the efficacy and safety of IBI302, an intravitreal injection, in patients with Diabetic Macular Edema (DME). Participants will be monitored for visual acuity and central subfield thickness changes over the course of the trial. The study will compare the effects of IBI302 against Faricimab, another treatment option, to determine which is more effective in managing DME. The trial will include patients aged 18-80 diagnosed with diabetes and experiencing specific visual acuity loss due to DME.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with type I or type II diabetes and diagnosed with Diabetic Macular Edema affecting the macular fovea.

Not a fit: Patients with high-risk proliferative diabetic retinopathy or other significant ocular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients suffering from Diabetic Macular Edema.

How similar studies have performed: Other studies have shown promising results with similar approaches in treating Diabetic Macular Edema, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai General hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yating Liu

Conditions Diabetic Macular Oedema