The study will evaluate the efficacy and safety of two different dosing regimens of ranibizumab (0.5 mg on BCVA by 1+PRN vs 3+PRN) in Chinese patients with wet AMD. This study is to provide long-term safety data in the treatment of Chinese patients with wet AMD.
Inclusion Criteria: Age ≥ 50 y/o, nAMD patients(including PCV) Best-corrected visual acuity(BCVA) Exclusion Criteria: Previous anti-VEGF treatment within 3 months History of intraocular surgery within 3 months or arrangement of intraocular surgery in the next 6 months from baseline Active or recent intraocular inflammation in the study eye Primary Endpoint: Improvement in BCVA compared to baseline Other: Central Macular Thickness after Treatment,Numbers of Injections
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the injection of the same does at the first month.
PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the first three monthly intravitreal injections of the same does.
Ranibizumab - a recombinant, humanized monoclonal antibody Fab that neutralizes all active forms of VEGF-A was recently approved by the Food and Drug Administration for the treatment of all angiographic subtypes of subfoveal neovascular age-related macular degeneration
Eye & Ent Hospital of Fudan University
Shanghai, China
RECRUITINGShanghai 10th People's Hospital
Shanghai, China
RECRUITINGShanghai First People's Hospital
Shanghai, China
Mean Snellen BCVA at every visit
Compare of mean Snellen Best-Corrected-visual-acuity and mean central macular thickness by OCT at every visit or treatment between the two groups to assess the efficacy of 1+PRN of Ranibizumab.
Time frame: 12 months
Number of participants with treatment-related adverse events
Compare of Number of participants with treatment-related adverse events between the two groups to assess the safety of 1+PRN of Ranibizumab.
Time frame: 12 months
Mean number of injections in 12 months
Compare of mean number of injection in 12 months between the two groups to assess the efficacy of 1+PRN of Ranibizumab.
Time frame: 12 months
mean central macular thickness at every visit by OCT
Compare of mean central macular thickness by OCT at every visit between the two groups to assess the efficacy of 1+PRN of Ranibizumab.
Time frame: 12 months
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Shanghai Zhongshan Hospital
Shanghai, China
RECRUITINGXinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITING