Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I Study of Ranibizumab Injection for Polypoidal Choroidal Vasculopathy (PEARL)

Conditions
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Polypoidal Choroidal Vasculopathy

Intervention / Treatment
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* Drug: ranibizumab intravitreal injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm study<br>Single arm study: Drug: ranibizumab intravitreal injection liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year | Drug: ranibizumab intravitreal injection<br>* liquid, 0.5 mg ranibizumab intravitreally, once a month for 1 year<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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choroidal neovascularization