Safety Study of Zimura™in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD

• Status: Completed
• Trial end date: 2018-04-24
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment experienced subjects with neovascular age-related macular degeneration (AMD)

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

Details

• Lead Sponsor: IVERIC bio, Inc.
• Treatments: Aflibercept; Bevacizumab; Ranibizumab

Criteria

Inclusion Criteria:

• Treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular age-related macular degeneration (NVAMD) in the study eye. There must be < 0 letters of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start of anti-VEGF treatment.

• Presence of subfoveal active choroidal neovascularization (CNV)

Exclusion Criteria:

• Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication, with the exception of the 1 prior anti-VEGF injections.

• Presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.

• Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry.

• Prior thermal laser in the macular region, regardless of indication.

• Ocular or periocular infection in the past twelve weeks.

• History of any of the following conditions or procedures in the study eye:

rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma drainage device, or corneal transplant.

• Previous therapeutic radiation in the region of the study eye.

• Evidence of diabetic retinopathy