This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving complete regression of polyps in patients with symptomatic macular polypoidal choroidal vasculopathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
61
After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, light application of 50 J/cm\^2 to the study eye was begun 15 minutes after the start of infusion.
Ranibizumab at dose of 0.5 mg administered as an intravitreal injection.
Novartis Investigative Site
Hong Kong, Hong Kong
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA)
Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.
Time frame: Month 6
Number of Participants With at Least One Complete Polyp Regression During 6 Months Assessed by ICGA
Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.
Time frame: Baseline through end of study (6 months)
Mean Change From Baseline in Central Retinal Thickness Measured by Optic Coherence Tomography (OCT)
High resolution 6 meridian scans were performed to measure central retinal thickness.
Time frame: Baseline and Month 6
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 6
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 6
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Bangkok, Thailand