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)

Phase 2

Completed

• Conditions: Idiopathic Polypoidal Choroidal Vasculopathy
• Interventions: Drug: Avacincaptad Pegol

• Registration Number: NCT02397954
• Lead Sponsor: Ophthotech Corporation

Brief 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).

Detailed Description

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.

Study Timeline

• Study Start: 2015-03-12
• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-25
• Primary Completion: 2015-10-23
• Study Completion: 2015-10-23
• Disposition First Submitted: 2017-04-04
• Disposition First Submitted QC: 2017-04-04
• Disposition First Posted: 2017-04-05
• Results First Submitted: 2019-01-02
• Results First Submitted QC: 2019-01-02
• Results First Posted: 2019-01-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avacincaptad Pegol + Anti-VEGF	Avacincaptad Pegol	Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with either Lucentis, Avastin or Eylea.

Primary Outcome Measures

Name	Time	Method
Number of Participants With >15 ETDRS Letter Loss at Month 3	3 Months	Number of participants with \>15 ETDRS letter loss (with calculated percentage)
Number of Participants With Ophthalmic Adverse Events	3 months	Number of Participants with Ophthalmic Adverse Events (with calculated percentage)
Number of Participants With Systemic Adverse Events	3 months	Number of Participants with Systemic Adverse Events (with calculated percentage)