This is a Phase III, multicenter, randomized, double-masked, dose-comparison study of the efficacy and safety of ranibizumab injection administered intravitreally to patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Results are presented for the first 12 months of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,097
Sterile solution for intravitreal injection.
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. A decrease in the BCVA score indicates a worsening of vision. A positive change score indicates improvement.
Time frame: Baseline to Month 12
Number of Ranibizumab Injections up to But Not Including Month 12
Time frame: Baseline to Month 12
Percentage of Patients Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) From Baseline at Month 12
BCVA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the patient. An increase in the BCVA score indicates an improvement of vision.
Time frame: Baseline to Month 12
Percentage of Patients With a Visual Acuity (VA) Snellen Equivalent of 20/40 or Better at Month 12
VA was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart starting at a test distance of 4 meters. An increase in the number of lines read correctly by the patient in the ETDRS chart indicates an improvement of vision. The Snellen equivalent of 20/40 is 14 lines correctly read in the EDTRS chart.
Time frame: Month 12
Percentage of Patients With no Evidence of Fluid From Choroidal Neovascularization (CNV) at Month 12
The presence of fluid from choroidal neovascularization (CNV) was assessed by spectral domain optical coherence tomography (SD-OCT). No evidence of fluid was defined as no subretinal fluid thickness, no cystoid spaces, no intraretinal fluid, no pigment epithelial defect thickness, and average central subfield thickness \< 270 µm.
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Unnamed facility
Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Arcadia, California, United States
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Beverly Hills, California, United States
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Campbell, California, United States
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Chico, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Mountain View, California, United States
...and 89 more locations
Time frame: Month 12
Change From Baseline in Central Foveal Thickness at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Central foveal thickness was assessed by spectral domain optical coherence tomography (SD-OCT).
Time frame: Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Change From Baseline in Macular Volume at Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Macular volume was assessed by spectral domain optical coherence tomography (SD-OCT).
Time frame: Baseline to Day 7 and Months 1, 2, 3, 4, 6, 9, and 12
Change From Baseline in the Total Area of Choroidal Neovascularization (CNV) and Choroidal Neovascular Leakage at Month 12
The total area of choroidal neovascularization (CNV) and choroidal neovascular leakage was assessed with fluorescein angiography (FA). Area was measured in disc area units; 1 disc area unit = 2.54 mm\^2.
Time frame: Baseline to Month 12