Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.
Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Monthly, intravitreal injection 0.05ml
Retina Consultants of Hawaii, Inc
Honolulu, Hawaii, United States
RECRUITINGRetina Consultants of Hawaii
‘Aiea, Hawaii, United States
RECRUITINGTo evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss
To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss, as measured by calculating the mean change in VA from baseline to Month 12
Time frame: 1 year
To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly
To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly
Time frame: 1 year
To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss
To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss as measured by the following: mean change from baseline in VA at 6 and 12 months, and the proportion of subjects who lose less than 5 letters of vision at Month 6 and Month 12.
Time frame: 1 year
To investigate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab on clinical findings associated with PCV
the mean change from baseline at M6 to M12 of subretinal hemorrhage and/or exudates via fundus photographs and fundus exams, decrease and/or complete resolution of branching vascular network from PCV at M3, M6, and M12 as assessed by FA and ICG, decrease and/or complete resolution of the branching vascular network (BVN) from PCV at M3, M6, and M12, as assessed by FA and ICG, mean change in central foveal thickness and/or peripapillary edema as measured by SD-OCT in central and/or paracentral fields from baseline, M3, M6 and M12, incidence of ocular AEs
Time frame: 1 year
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