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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 601 1.25mg | Experimental | loading phase (6 months): 601 1.25mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses |
|
| ranibizumab 0.5mg | Active Comparator | loading phase (6 months): ranibizumab 0.5mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 601 1.25mg | Drug | loading phase (6 months): 601 1.25mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| best-corrected visual acuity (BCVA) | Assessed with Early treatment diabetic retinopathy study (ETDRS) visual acuity testing charts. | From Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| best-corrected visual acuity (BCVA) | Assessed with Early treatment diabetic retinopathy study (ETDRS) visual acuity testing charts. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaorong Li, MD | Tianjin Medical University Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BeiJing Hospital | Beijing | Beijing Municipality | 100730 | China | ||
| The First Affiliated Hospital of JiNan University |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| ranibizumab 0.5mg | Drug | loading phase (6 months): ranibizumab 0.5mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses |
|
|
| up to 52 weeks |
| Number of injections | Number of administered injections for 601 or ranibizumab | 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.) | 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 | up to 52 weeks |
| Blood concentrations of Vascular Endothelial Growth Factor (VEGF) | Detect the blood concentrations of VEGF through the subject's blood sample | up to 52 weeks |
| 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. | up to 52 weeks |
| Guangzhou |
| Guangdong |
| 510630 |
| China |
| HeNan Provincial Eye Hospital | Zhengzhou | Henan | 450003 | China |
| The Second XiangYa Hospital of Central South University | Changsha | Hunan | 410011 | China |
| JiangSu Province Hospital | Nanjing | Jiangsu | 210029 | China |
| ShangHai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610000 | China |
| TianJin Eye Hospital | Tianjin | Tianjin Municipality | 300020 | China |
| TianJin Medical University Eye Hospital | Tianjin | Tianjin Municipality | 300384 | China |
| ZheJiang Province People's Hospital | Hangzhou | Zhejiang | 310024 | China |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |