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RECRUITING
NCT06908876
PHASE2

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

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-04-24

Completion Date

2027-02-28

Last Updated

2025-05-25

Healthy Volunteers

No

Interventions

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.

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.

Locations (1)

Shanghai General hospital

Shanghai, Shanghai Municipality, China