A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）
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
Innovent Biologics Technology Limited (Shanghai R&D Center)
150 participants
Apr 24, 2025
INTERVENTIONAL
Conditions
Summary
The study is designed for multi-center,randomized,double-masked,active-contralledstudy to evaluate effective and security of intravitrealinjection of IBI302 in subjects with Diabetic Macular Oedema.
Eligibility
Inclusion Criteria6
- 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 Criteria17
- 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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Interventions
4 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by Pro re nata (PRN) regimen.
8 mg IBI302 will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by PRN regimen.
6 mg faricimab will be administered by intravitreal injection into the study eye once every 4 weeks for 4 consecutive months, followed by PRN regimen.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06908876