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

Phase 2TerminatedNCT05571267

IVERIC bio, Inc.1 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neovascular Age-Related Macular Degeneration

Interventions

Avacincaptad PegolDRUG

Zimura 2 mg, administered by intravitreal injection

AvastinDRUG

Avastin 1.25 mg, administered by intravitreal injection

LucentisDRUG

Lucentis 0.5 mg, administered by intravitreal injection

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Participants With >0 Letter Loss

Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.

Time frame: Month 12

Percentage of Participants With >0 Letter Loss

Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.

Time frame: Month 18

Percentage of Participants With >5 Letter Loss

Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.

Time frame: Month 12

Percentage of Participants With >5 Letter Loss

Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.

Time frame: Month 18

Percentage of Participants With >10 Letter Loss

Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.

Time frame: Month 12

Percentage of Participants With >10 Letter Loss

Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.

Time frame: Month 18

Data from ClinicalTrials.gov

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