This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
321
After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 (Standard Fluence rate) or 25 J/cm\^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.
Ranibizumab 0.5 mg administered as an intravitreal injection.
To maintain masking, as a placebo for verteporfin photodynamic therapy, patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion.
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.
Time frame: Baseline and Month 12
Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit
The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.
Time frame: Month 2 up to Month 11
Change From Baseline in Total Area of Leakage of the Study Eye at Month 12
Total area of leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).
Time frame: Baseline and Month 12
Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12
The percentage of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).
Time frame: Month 12
Change From Baseline in Central Retinal Thickness at Month 12
Optical coherence tomography was performed in the study eyes and the evaluations of the images were performed by the central reading center.
Time frame: Baseline and Month 12
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To maintain masking, patients in the combination groups received sham intravitreal injections whenever retreatment with active Ranibizumab was not warranted based on the retreatment algorithm.
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Beverly Hills, California, United States
Novartis Investigative Site
Oakland, California, United States
Novartis Investigative Site
Pasadena, California, United States
Novartis Investigative Site
Sacramento, California, United States
West Coast Retina Medical Group Inc. - 185 Berry St. Suite 130
San Francisco, California, United States
Novartis Investigative Site
Santa Ana, California, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
‘Aiea, Hawaii, United States
Novartis Investigative Site
Iowa City, Iowa, United States
...and 33 more locations