Expired Study
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Phoenix, Arizona 85014


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).

Study summary:

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.


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)



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Phoenix, Arizona 85014
United States

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Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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