The purpose of the study is to provide efficacy and safety data for monthly ranibizumab 0.5 mg intravitreal injections in Chinese patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study results will support the regulatory submission in China to make ranibizumab available for clinical use.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Beijing, China
Novartis Investigational Site
Chengdu, China
Novartis Investigative Site
Guangzhou, China
To evaluate efficacy of ranibizumab 0.5 mg by mean change in best-corrected visual acuity (BCVA) from Baseline to Month 4 as assessed with early treatment of diabetic retinopathy study (ETDRS) like charts at a distance of 4 meters.
Time frame: 12 months
To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12.
Time frame: 12 Months
To evaluate effects of ranibizumab 0.5 mg on retinal structure at Month 4 and Month 12 as assessed by fundus photography, fluorescein angiography, and optical coherence tomography.
Time frame: 12 Months
To evaluate safety of ranibizumab 0.5 mg by rates of adverse events/SAEs, ophthalmic exams, tonometry, and changes in laboratory values/vital signs at Months 4 and 12.
Time frame: 12 Months
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Novartis Investigative Site
Shanghai, China
Novartis Investigative Site
Shanghai, China