A Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

Study Overview
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Brief Summary
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The objectives of this study are to evaluate the safety and tolerability of Zimura™ intravitreous injection in combination with anti-vascular endothelial growth factor (VEGF) therapy in subjects with Idiopathic Polypoidal Choroidal Vasculopathy (IPCV).

Detailed Description
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Treatment experienced (Prior treatment with anti-VEGF monotherapy of ≥8 injections in the previous twelve (12) months) subjects of either gender aged 50 years or above with a diagnosis of IPCV, will receive 3 monthly (Q4W) intravitreal injections of Zimura™ (1 mg/eye) in combination with anti-VEGF therapy (Avastin® 1.25 mg/eye or Lucentis® 0.5 mg/eye or Eylea® 2 mg/eye). Safety endpoints include visual acuity loss (proportion of subjects with >15 letter loss at Month 3), ophthalmic adverse events (AEs), systemic adverse events (AEs), change in total retinal thickness (SD-OCT) at Month 3, regression and/or elimination of polyps at Month 3 compared to screening as measured by indocyanine green angiography (ICGA), and laboratory values.

Official Title
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A Phase 2a Study to Establish the Safety and Tolerability of Zimura® (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

Conditions
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Idiopathic Polypoidal Choroidal Vasculopathy

Intervention / Treatment
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* Drug: Zimura


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of either gender aged ≥ 50 years Diagnosis of IPCV Treatment-experienced defined as prior treatment with anti-VEGF mono therapy of ≥ 8 injections in the previous twelve (12) months Exclusion Criteria: Any intraocular surgery or thermal laser within three (3) months of trial entry Any prior thermal laser in the macular region, regardless of indication Any ocular or periocular infection in the twelve (12) weeks prior to entry History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant Previous therapeutic radiation in the region of the study eye A diagnosis of diabetic retinopathy (presence of microaneurysms or any vasculopathy and/or leakage from retinal vasculature in a subject with diabetes mellitus)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Zimura + Anti-VEGF<br>Subjects will receive monthly intravitreous injections of Zimura in combination with either Lucentis, Avastin or Eylea. | Drug: Zimura<br>* Subjects will receive monthly intravitreous injections of Zimura in combination with Lucentis, Avastin or Eylea.<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With >15 ETDRS Letter Loss at Month 3 | Number of participants with >15 ETDRS letter loss (with calculated percentage) | 3 Months | 
| Number of Participants With Ophthalmic Adverse Events | Number of Participants with Ophthalmic Adverse Events (with calculated percentage) | 3 months | 
| Number of Participants With Systemic Adverse Events | Number of Participants with Systemic Adverse Events (with calculated percentage) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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idiopathic polypoidal choroidal vasculopathy, IPCV, Zimura™, Avastin®, Eylea®, Lucentis®