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)

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ophthotech Corporation
• Treatments: Bevacizumab; Ranibizumab

Criteria

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)