A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）

Phase 2

Recruiting

• Conditions: Diabetic Macular Oedema
• Interventions: Biological: IBI302; Drug: Faricimab

• Registration Number: NCT06908876
• Lead Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-03-27
• Study First Posted: 2025-04-03
• Study Start: 2025-04-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-12-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI302 Dose 8mg	IBI302	Drug: IBI302 8mg/eye; Intraocularinjection
IBI302 Dose 4mg	IBI302	Drug: IBI302 4mg/eye; Intraocularinjection
Faricimab	Faricimab	Drug: Faricimab 6mg/eye; Intraocularinjection

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai General hospital; 🇨🇳 Shanghai, Shanghai, China