Clinical trial NCT00424710: Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)
Official title: Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Polypoidal Choroidal Vasculopathy
Keywords: choroidal neovascularization
Lead sponsor: Hawaii Pacific Health
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-01-19
Enrollment: 17
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Efficacy Measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 6 and 12 month compared with baseline
timeFrame: 1 year
measure: Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment
timeFrame: 1 Year
Secondary outcomes:
measure: Efficacy as measured by the mean change from baseline in VA at 6 and 12 months
timeFrame: 1 Year
measure: Efficacy as measured by the proportion of subjects who lose less than 5 letters of vision at month 6 and 12
timeFrame: 1 Year
measure: Efficacy as mean change from baseline at 6 to 12 months in decreasing subretinal hemorrhage or subretinal exudates via fundus photographs and fundus exams
timeFrame: 1 Year
measure: 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
timeFrame: 1 Year
measure: 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.
timeFrame: 1 Year
Other outcomes:
Locations:
city: Aiea
country: United States
facility: The Retina Center at Pali Momi
state: Hawaii
city: Honolulu
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
Study officials:
affiliation: The Retina Center at Pali Momi
name: Gregg T Kokame, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kokame GT, Yeung L, Lai JC. Continuous anti-VEGF treatment with ranibizumab for polypoidal choroidal vasculopathy: 6-month results. Br J Ophthalmol. 2010 Mar;94(3):297-301. doi: 10.1136/bjo.2008.150029. Epub 2009 Sep 1.