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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)
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
Conditions
Interventions
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.
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.
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