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)

Ophthotech Corporation4 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Idiopathic Polypoidal Choroidal Vasculopathy

Interventions

Avacincaptad PegolDRUG

Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with Lucentis, Avastin or Eylea.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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)

Locations (1)

Unnamed facility

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Number of Participants With >15 ETDRS Letter Loss at Month 3

Number of participants with \>15 ETDRS letter loss (with calculated percentage)

Time frame: 3 Months

Number of Participants With Ophthalmic Adverse Events

Number of Participants with Ophthalmic Adverse Events (with calculated percentage)

Time frame: 3 months

Number of Participants With Systemic Adverse Events

Number of Participants with Systemic Adverse Events (with calculated percentage)

Time frame: 3 months

Data from ClinicalTrials.gov

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