Safety Study of High-Dose Ranibizumab for Polypoidal Choroidal Vasculopathy

Study Overview
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Brief Summary
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Monthly, continuous anti-vegf therapy for patients presenting with active polypoidal choroidal vasculopathy. Two arms, treatment naive and previously treated with an FDA approved anti-VEGF therapy, will be randomized and dosed with open label 2.0mg ranibizumab.

Detailed Description
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Patients will be followed with spectral oct, 4m BCVA, ICG, FA and monthly eye examinations for one year.

Official Title
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Investigator Sponsored Trial of Polypoidal Choroidal Vasculopathy (PCV) Evaluation Assessing High-Dose Ranibizumab (2.0mg) Prospectively

Conditions
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Polypoidal Choroidal Vasculopathy

Intervention / Treatment
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* Drug: ranibizumab 2.0mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age >= 25 years Polypoidal choroidal vasculopathy as noted on fluorescein and ICG angiography: active leakage, active bleeding or recent decrease in vision BVCA using ETDRS of 20/32 to 20/400 Exclusion Criteria: Any history of prior vitrectomy Any prior treatment with verteporfin PDT in the study eye Previous cataract surgery within the preceding 2 months of D0 Active intraocular inflammation in the study eye Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye A condition, that in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease) Participation in another investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry. Prior anti-VEGF (Macugen, Avastin, Lucentis) in the study eye within 30 days prior to enrollment in this study Known allergy to any component in the study drug Uncontrolled hypertension: >180/110 major surgery within 28 days prior to randomization Myocardial infarction, other cardia events requiring hospitalization within 6 months prior to randomization Systemic anti-VEGF or pro-VEGF within 3 months of randomization Pregnancy or lactation History of recurrent significant infections or bacterial infections

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Previously Treated<br>With prior anti-vegf therapy, only, no sooner than 30 days prior to enrollment into trial | Drug: ranibizumab 2.0mg<br>* Monthly, intravitreal injection 0.05ml<br>|
| Experimental: Treatment-Naive<br>Treatment-Naive: no previous treatment for PCV | Drug: ranibizumab 2.0mg<br>* Monthly, intravitreal injection 0.05ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss | To evaluate the efficacy of intravitreal injections of 2.0mg ranibizumab administered monthly in preventing vision loss, as measured by calculating the mean change in VA from baseline to Month 12 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly | To evaluate the safety and tolerability of intravitreal injections of 2.0mg ranibizumab administered monthly | 1 year | 
| To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss | To evaluate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab in preventing vision loss as measured by the following: mean change from baseline in VA at 6 and 12 months, and the proportion of subjects who lose less than 5 letters of vision at Month 6 and Month 12. | 1 year | 
| To investigate the efficacy of monthly intravitreal injections of 2.0mg ranibizumab on clinical findings associated with PCV | the mean change from baseline at M6 to M12 of subretinal hemorrhage and/or exudates via fundus photographs and fundus exams, decrease and/or complete resolution of branching vascular network from PCV at M3, M6, and M12 as assessed by FA and ICG, decrease and/or complete resolution of the branching vascular network (BVN) from PCV at M3, M6, and M12, as assessed by FA and ICG, mean change in central foveal thickness and/or peripapillary edema as measured by SD-OCT in central and/or paracentral fields from baseline, M3, M6 and M12, incidence of ocular AEs | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCV, polypoidal, choroidal, vasculopathy