To compare the efficacy and safety of recombinant humanized anti-VEGF monoclonal antibody (601) with Ranibizumab in patients with macular edema secondary to BRVO
After a up to 14-day screening period, patients will be randomized allocated in 2 groups at 1:1 ratio and followed up for 52 weeks. Followed-up visits will be scheduled at a 4-week interval. After 6 initial monthly injections of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 24 to week 48). During the IFT phase, subjects will receive either the injections or not based on the assessment of disease stability at each visit. Efficacy and safety outcomes will be evaluated up to a period of 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
351
loading phase (6 months): 601 1.25mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses
loading phase (6 months): ranibizumab 0.5mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses
BeiJing Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of JiNan University
Guangzhou, Guangdong, China
HeNan Provincial Eye Hospital
Zhengzhou, Henan, China
best-corrected visual acuity (BCVA)
Assessed with Early treatment diabetic retinopathy study (ETDRS) visual acuity testing charts.
Time frame: From Baseline to Week 24
best-corrected visual acuity (BCVA)
Assessed with Early treatment diabetic retinopathy study (ETDRS) visual acuity testing charts.
Time frame: up to 52 weeks
central retinal thickness (CRT)
SD-OCT (spectral domain optical coherence tomography) was used to assess the average retinal thickness of the central 1 mm diameter subfield around the foveal center.
Time frame: up to 52 weeks
Number of injections
Number of administered injections for 601 or ranibizumab
Time frame: up to 52 weeks
Adverse Events (AEs)
All adverse events related to 601 or ranibizumab observed through various tests (including blood routine, pregnancy test, electrocardiogram, etc.)
Time frame: up to 52 weeks
Steady-state Blood concentrations of 601 or ranibizumab
Detect the steady-state blood concentrations of 601 or ranibizumab through the subject's blood sample
Time frame: up to 52 weeks
Blood concentrations of Vascular Endothelial Growth Factor (VEGF)
Detect the blood concentrations of VEGF through the subject's blood sample
Time frame: up to 52 weeks
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The Second XiangYa Hospital of Central South University
Changsha, Hunan, China
JiangSu Province Hospital
Nanjing, Jiangsu, China
ShangHai General Hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
TianJin Eye Hospital
Tianjin, Tianjin Municipality, China
TianJin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
ZheJiang Province People's Hospital
Hangzhou, Zhejiang, China
anti-drug antibody (ADA) of 601
Detect the presence of anti-drug antibody (ADA) of 601 through the subject's blood sample. ADA-positive subjects will also undergo further Neutralization antibody (Nab) testing.
Time frame: up to 52 weeks