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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
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.
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.
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.
Shanghai General hospital
Shanghai, Shanghai Municipality, China
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.
Time frame: From Baseline through At Week 16
The proportion of patients with an ≥ 2-step DRSS improvement
DRSS level is evaluated by color fundus photography (CFP).
Time frame: At Week 16 and 36
The proportion of patients with PDR
The presence of PDR is evaluated by CFP.
Time frame: The proportion of patients with PDR
The proportion of new developed PDR
The presence of new developed PDR is evaluated by CFP.
Time frame: At Week 16 and 36
Change from baseline in BCVA over time
Change from baseline in BCVA as measured on ETDRS chart
Time frame: From Baseline through Week 36
The proportion of patients with CST < 320 μm over time
CST is measured by Optical coherence tomography (OCT).
Time frame: 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.
Time frame: From Baseline through Week 36
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