Actively Recruiting
A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）
Led by Innovent Biologics Technology Limited (Shanghai R&D Center) · Updated on 2025-05-25
150
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willing to complete study visits as planned
- Aged 18 to 80 years at screening
- Diagnosed with type I or type II diabetes
- Diabetic macular oedema involving the macular fovea
- Central subfield thickness (CST) ≥320 µm confirmed by OCT in the study eye
- Best corrected visual acuity (BCVA) in the study eye between 19 and 78 ETDRS letters
- Currently using insulin, injectable drugs, or oral hypoglycemic agents with HbA1c ≤10% at screening
You will not qualify if you...
- High-risk proliferative diabetic retinopathy (PDR) in the study eye
- Dense hard exudation destroying the fovea structure in the study eye
- Iris neovascularization in the study eye
- Systemic or ocular diseases affecting the study eye that may interfere with treatment or study results
- Uncontrolled glaucoma in the study eye
- 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 in the study eye within 90 days prior to baseline
- Cataract surgery in the study eye within 90 days prior to baseline
- YAG laser capsulotomy or peripheral iridotomy in the study eye within 90 days prior to baseline
- Other intraocular surgeries such as corneal transplantation, glaucoma filtration, vitrectomy, or radiotherapy
- Untreated diabetes or starting diabetes medication less than 90 days before treatment
- Uncontrolled hypertension
- Systemic use of anti-VEGF or anti-complement agents within 90 days prior to baseline
- Pre-existing diseases or conditions increasing risk or interfering with study
- Systemic treatment for suspected or active infections such as tuberculosis or hepatitis
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
Y
Yating Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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