Polypoidal Choroidal Vasculopathy
Conditions
Keywords
choroidal neovascularization
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.
Interventions
liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year
Sponsors
Genentech, Inc.
Hawaii Pacific Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Efficacy as measured by the mean change from baseline in VA at 6 and 12 months | 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 macular edema as measured by OCT in central or paracentral fields from baseline month 6 and month 12. | 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 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 |
Countries
United States
Outcome results
None listed