Overview

Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Hawaii Pacific Health
Collaborator:
Genentech, Inc.
Treatments:
Ranibizumab
Criteria
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