This is a 12 month study of monthly injections of ranibizumab in subjects with polypoidal choroidal vasculopathy as diagnosed by fluoresceins/indocyanine green (FA/ICG) angiography.
Previous treatment in subjects is allowed as long as appropriate washout period has elapsed. Patients will be followed by 4M ETDRS vision testing as well as scheduled OCT, ICG, FA and Fundus Photography.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
Retina Consultants of Hawaii
Honolulu, Hawaii, United States
The Retina Center at Pali Momi
‘Aiea, Hawaii, United States
Efficacy Measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 6 and 12 month compared with baseline
Time frame: 1 year
Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment
Time frame: 1 Year
Efficacy as measured by the mean change from baseline in VA at 6 and 12 months
Time frame: 1 Year
Efficacy as measured by the proportion of subjects who lose less than 5 letters of vision at month 6 and 12
Time frame: 1 Year
Efficacy as mean change from baseline at 6 to 12 months in decreasing subretinal hemorrhage or subretinal exudates via fundus photographs and fundus exams
Time frame: 1 Year
Efficacy as proportion of subjects with a decrease in size of the polypoidal vessels from PCV at Mo 6 and 12 as assessed by FA and ICG Angiography
Time frame: 1 Year
Efficacy as proportion of subjects with a decrease in macular edema as measured by OCT in central or paracentral fields from baseline month 6 and month 12.
Time frame: 1 Year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.