Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV) (PEARL)

Hawaii Pacific Health

Status and phase

Completed

Phase 1

Conditions

Polypoidal Choroidal Vasculopathy

Treatments

Drug: ranibizumab intravitreal injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00424710

FVF3934s

Details and patient eligibility

About

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.

Full description

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.

Enrollment

17 patients

Sex

All

Ages

25+ years old

Volunteers

Accepts Healthy Volunteers

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