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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Macular Oedema
• Intervention / Treatment: Biological: IBI302; Biological: IBI302; Drug: Faricimab

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200080
      • Shanghai General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI302 Dose 8mg; Drug: IBI302 8mg/eye; Intraocularinjection	Biological: IBI302; 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.; Biological: IBI302; 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.
Active Comparator: Faricimab; Drug: Faricimab 6mg/eye; Intraocularinjection	Drug: Faricimab; 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.
Experimental: IBI302 Dose 4mg; Drug: IBI302 4mg/eye; Intraocularinjection	Biological: IBI302; 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.; Biological: IBI302; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BCVA change from baseline	Change from baseline in BCVA as measured on The BCVA is measured by Early Treatment Diabetic Retinopathy Study (ETDRS) chart at week 16.	From Baseline through At Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with an ≥ 2-step DRSS improvement	DRSS level is evaluated by color fundus photography (CFP).	At Week 16 and 36
The proportion of patients with PDR	The presence of PDR is evaluated by CFP.	The proportion of patients with PDR
The proportion of new developed PDR	The presence of new developed PDR is evaluated by CFP.	At Week 16 and 36
Change from baseline in BCVA over time	Change from baseline in BCVA as measured on ETDRS chart	From Baseline through Week 36
The proportion of patients with CST < 320 μm over time	CST is measured by Optical coherence tomography (OCT).	From Baseline through Week 36
AEs over time	All AEs were recorded and the investigator made an assessment on severity and causality of each AE.	From Baseline through Week 36

Collaborators and Investigators

• Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: March 27, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Edema; Macular Edema; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; faricimab; IBI302
• Other Study ID Numbers: CIBI302B202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No