This is a randomized, double-masked, multicenter study comparing the the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) versus aflibercept in patients with wet age-related macular degeneration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
432
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 µL dose.
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 µL dose.
Beijing Hospital
Beijing, Beijing Municipality, China
RECRUITINGMean change from baseline in BCVA at week 48;
BCVA=Best-corrected visual acuity; Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Time frame: Baseline, week 48
Average change in BCVA from baseline over the period week 36 through week 48;
For each subject, this endpoint is defined as the average of the changes from Baseline to Weeks 36, 40, 44 and 48.
Time frame: Baseline, weeks 36, 40, 44 and 48.
Proportion of subjects with q12w injection;
q12w=every 12 weeks
Time frame: Baseline, week 48
Proportion of subjects with q12w injection at week 48 within the subjects with no q8w injection need at week 16, week 20;
for subjects randomized to RC28-E group only; q12w=every 12 weeks; q8w=every 8 weeks; A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w injection need.
Time frame: Week 16, 20, 48
Proportion of subjects with gain in BCVA of 15/10/5/0 letters or more from baseline to week 48;
Proportion of subjects; BCVA=Best-corrected visual acuity;
Time frame: Baseline, week 48
Mean change in CST from baseline to week 16, week 48;
CST=Central retinal subfield thickness
Time frame: Baseline, week 16, 48
Average change in CST from baseline over the period week 36 through week 48;
CST=Central retinal subfield thickness
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Time frame: Baseline, weeks 36, 40, 44 and 48.
Proportion of subjects with presence of intraretinal fluid/subretinal fluid at week 16, week 48;
Intraretinal fluid was assessed using SD-OCT and recorded as Present/Absent. Subretinal fluid was assessed using SD-OCT and recorded as Present/Absent. The presence of intraretinal fluid/subretinal fluid is an indicator of underlying disease.
Time frame: Baseline, week 16, 48
Percentage of subjects with disease activity present at week 16;
A disease activity assessment (DAA) was performed to identify q8w injection need. 95% confidence interval (CI) for binomial proportions is based on Clopper-Pearson exact method. One eye (study eye) contributed to the analysis. Hypothesis testing not pre-specified.
Time frame: Baseline, week 16
Change in choroidal neovascularization (CNV) lesion size from baseline to week 12, week 48;
CNV lesion size (the area of new blood vessels in the choroid layer of the retina) was measured using fundus fluorescein angiography (FFA). A negative change value indicates a reduction in lesion size, whereas a positive change value indicates an increase. An increase in CNV lesion size may indicate progression of the underlying disease. Only one eye (study eye) contributed to the analysis.
Time frame: Baseline, week 12, 48
Proportion of subjects with q8w treatment need at weeks 16, 20, 28, 32, 40, 44;
q8w=every 8 weeks; A disease activity assessment (DAA) was performed at pre-specified visits (Weeks 16, 20, 28, 32, 40, 44) to identify q8w need. This outcome measure was pre-specified for RC28-E arm only.
Time frame: Weeks 16, 20, 28, 32, 40, 44
Incidence and characteristics of ocular and systemic treatment emergent adverse events.
safety endpoint
Time frame: Baseline, week 48