Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)
Phase 1
Completed
- Conditions
- Polypoidal Choroidal Vasculopathy
- Interventions
- Registration Number
- NCT00424710
- Lead Sponsor
- Hawaii Pacific Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm study ranibizumab intravitreal injection Single arm study: Drug: ranibizumab intravitreal injection liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
- Primary Outcome Measures
Name Time Method Efficacy Measured by the proportion of subjects who lose fewer than 15 letters in visual acuity at 6 and 12 month compared with baseline 1 year Safety and Tolerability as measured by the recording and observations of adverse effects of study treatment 1 Year
- Secondary Outcome Measures
Name Time Method Efficacy as measured by the mean change from baseline in VA at 6 and 12 months 1 Year Efficacy as measured by the proportion of subjects who lose less than 5 letters of vision at month 6 and 12 1 Year Efficacy as mean change from baseline at 6 to 12 months in decreasing subretinal hemorrhage or subretinal exudates via fundus photographs and fundus exams 1 Year 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 1 Year 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. 1 Year
Trial Locations
- Locations (2)
The Retina Center at Pali Momi
🇺🇸Aiea, Hawaii, United States
Retina Consultants of Hawaii
🇺🇸Honolulu, Hawaii, United States