Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)
Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)
Lead SponsorHawaii Pacific Health
StatusCompleted No Results Posted
Indication/ConditionPolypoidal Choroidal Vasculopathy
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.
liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
Single arm study: Drug: ranibizumab intravitreal injection liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
Inclusion Criteria: Ability to provide informed consent and comply with study assessment for the duration of one year Age >= 25 years Polypoidal Choroidal Vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision BCVA using ETDRS 20/32 to 20/400 Exclusion Criteria: Any history of previous vitrectomy Previous cataract or ocular surgery within 2 months of day 0 Active intraocular inflammation in the study eye Active infections conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye Participation with another investigational drug within the past 30 days Prior sodium pegaptanib, verteporfin photodynamic therapy, intravitreal steroids, or bevacizumab within 30 days of study entry Blood pressure >180/110 (use of antihypertensives is allowed as long as hypertension can be controlled and is stable) Pregnancy