The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.
A multicenter, multinational, double-masked, parallel-group, dose-ranging, active-controlled, randomized trial, which will randomize approximately 1140 subjects in a ratio of 1:1:1 to receive IVT injections of 0.5 mg conbercept, 1.0 mg conbercept, or 2.0 mg aflibercept. The trial includes a screening period of less than or equal to 14 days, followed by a treatment period of 92 weeks (last assessment at 96 weeks) with primary efficacy analysis at 36 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,157
Subjects received 0.5 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (0.5 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based pro re nata (PRN) approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
Subjects received 1.0 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every twelve weeks thereafter (1.0 mg, q12w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye
BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method
Time frame: Baseline to Week 36
Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36
To Assess Proportion of subjects maintaining vision (i.e., losing \<15 ETDRS BCVA letters) from baseline to Week 36
Time frame: Baseline to Week 36
Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36
To Assess Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36
Time frame: Baseline to Week 36
Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week
To Assess Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week
Time frame: Baseline and Week 36
Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48
To Assess Proportion of subjects maintaining vision (i.e. losing \<15 ETDRS BCVA letters) from baseline to Week 48
Time frame: Baseline to Week 48
Mean change from baseline in ETDRS BCVA letter score at Week 96
To Assess Mean change from baseline in ETDRS BCVA letter score at Week 96
Time frame: Baseline and Week 96
Number of participants with adverse events as measure of safety and tolerability
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Subjects received 2.0 mg aflibercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (2.0 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
Kanghong Investigative Site
Phoenix, Arizona, United States
Kanghong Investigative Site
Phoenix, Arizona, United States
Kanghong Investigative Site
Springdale, Arkansas, United States
Kanghong Investigative Site
Arcadia, California, United States
Kanghong Investigative Site
Arcadia, California, United States
Kanghong Investigative Site
Bakersfield, California, United States
Kanghong Investigative Site
Encino, California, United States
Kanghong Investigative Site
Glendale, California, United States
Kanghong Investigative Site
Glendora, California, United States
Kanghong Investigative Site
Huntington Beach, California, United States
...and 144 more locations
To Assess Number of participants with adverse events as measure of safety and tolerability
Time frame: Baseline to Week 96
Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible
To Assess Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible
Time frame: Baseline to Week 96
Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible
To Assess Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible
Time frame: Baseline to Week 96
Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible
To Assess Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible
Time frame: Baseline to Week 96