Status:
COMPLETED
Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)
Lead Sponsor:
Hawaii Pacific Health
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Polypoidal Choroidal Vasculopathy
Eligibility:
All Genders
25+ years
Phase:
PHASE1
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 Photograp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00424710
Start Date
January 1 2007
End Date
September 1 2010
Last Update
November 5 2014
Active Locations (2)
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1
Retina Consultants of Hawaii
Honolulu, Hawaii, United States, 96817
2
The Retina Center at Pali Momi
‘Aiea, Hawaii, United States, 96701