The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
316
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGChange from baseline in BCVA at Week 52
BCVA=best-corrected visual acuity; Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a starting distance of 4 meters
Time frame: Baseline, week 52
Average change in BCVA from baseline over the period week 40 through week 52
For each subject, this endpoint is defined as the average of the changes from baseline to weeks 40, 44, 48 and 52
Time frame: Baseline, weeks 40, 44, 48 and 52
Change from baseline in BCVA over time
BCVA will be assessed at each visit
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
Proportion of patients of gaining 4 types of letter counting in BCVA, respectively
Time frame: Baseline, week 52
Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
Proportion of patients of reducing 4 types of letter counting in BCVA, respectively
Time frame: Baseline, week 52
Change from baseline in CST at Week 52
CST=central subfield thickness
Time frame: Baseline, week 52
Mean change from baseline in CST over a period of week 40 through week 52
CST=central subfield thickness
Time frame: Baseline, weeks 40, 44, 48 and 52.
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Change from baseline in CST over time
The change of CST will be assessed from baseline to 52 weeks by every 4 week intervals
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of patients with absence of intraretinal fluid at Week 52
Proportion of patients whose intraretinal fluid are completely improved
Time frame: Baseline, week 52
Proportion of patients with absence of subretinal fluid at Week 52
Proportion of patients whose subretinal fluid are completely improved
Time frame: Baseline, week 52
Proportion of patients with absence of intraretinal fluid and subretinal fluid at Week 52
Proportion of patients whose intraretinal fluid and subretinal fluid are both completely improved
Time frame: Baseline, week 52
Proportion of patients with a >2-step or>3-step DRS worsening from baseline on ETDRS DRSS at Week 52
DRSS=Diabetic Retinopathy Severity Scale
Time frame: Baseline, week 52
Proportion of patients who develop new PDR or high risk PDR at Week 52
PDR=proliferative diabetic retinopathy
Time frame: Baseline, week 52
Incidence and severity of ocular adverse events and non-ocular adverse events
during the study
Time frame: 0~52 weeks
Plasma concentration of RC28-E over time
during the study
Time frame: Baseline, weeks 16, 36 and 48
Presence of ADAs during the study relative to the presence of ADAs at baseline
during the study
Time frame: Baseline, weeks 12, 24, 36 and 52