This is a 24-month study of ranibizumab (2.0 mg and 1.0 mg) in subjects with polypoidal choroidal vasculopathy as diagnosed by fluorescein/indocyanine green (FA/ICG) angiography.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
20mg ranibizumab vials, 0.05ml injected intravitreally, monthly
3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
Retina Consultants of Hawaii
Honolulu, Hawaii, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, United States
The Retina Center at Pali Momi
‘Aiea, Hawaii, United States
BCVA
Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at a starting test distance of 4 meters from Baseline to Month 12.
Time frame: From Baseline to Month 12
BCVA
Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters from Baseline to Month 24
Time frame: Baseline to M24
Ocular Adverse Events (AE)
Incidence and severity of ocular adverse events, as identified by eye examination (including visual acuity testing)
Time frame: Monthly
Systemic AEs
Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs
Time frame: Monthly
BCVA
Best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters, at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24
Time frame: at Baseline, Day 14, Month 1, Month 3, Month 6, Month 9 , Month 12, Month 15, Month 18, Month 21 and Month 24
Macular Edema
Optical Coherence Tomography (OCT) central macular and peripapillary thickness
Time frame: Baseline, Day 14, Month 1-24
PCV Anatomic Changes
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Decrease and/or resolution in the branching vascular network of the PCV complex as measured by mean size of the branched vascular network (BVN) on ICG and fluorescein angiography Decrease and/or resolution of the polyps of the PCV complex as measured on ICG and fluorescein angiography
Time frame: Baseline, Months 6, 12, 24
Fundus Clinical Findings
Decrease in subretinal hemorrhage or exudates as measured by mean size as noted on fundus photography and clinic exam
Time frame: Baseline, Months 6, 12, 24