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

NCT ID: NCT05571267

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-20
• Study Completion Date: 2018-04-24

Brief 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)

Conditions

Neovascular Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Avacincaptad Pegol and Avastin

Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Avacincaptad Pegol.

Group Type: EXPERIMENTAL

Avacincaptad Pegol

Intervention Type: DRUG

Zimura 2 mg, administered by intravitreal injection

Avastin

Intervention Type: DRUG

Avastin 1.25 mg, administered by intravitreal injection

Avacincaptad Pegol and Lucentis

Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Avacincaptad Pegol.

Group Type: EXPERIMENTAL

Avacincaptad Pegol

Intervention Type: DRUG

Zimura 2 mg, administered by intravitreal injection

Lucentis

Intervention Type: DRUG

Lucentis 0.5 mg, administered by intravitreal injection

Avacincaptad Pegol and Eylea

Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Avacincaptad Pegol.

Group Type: EXPERIMENTAL

Avacincaptad Pegol

Intervention Type: DRUG

Zimura 2 mg, administered by intravitreal injection

Eylea

Intervention Type: DRUG

Eylea 2 mg, administered by intravitreal injection

Interventions

Avacincaptad Pegol

Zimura 2 mg, administered by intravitreal injection

Intervention Type: DRUG

Avastin

Avastin 1.25 mg, administered by intravitreal injection

Intervention Type: DRUG

Lucentis

Lucentis 0.5 mg, administered by intravitreal injection

Intervention Type: DRUG

Eylea

Eylea 2 mg, administered by intravitreal injection

Intervention Type: DRUG

Other Intervention Names

Zimura (previous name); IZERVAY; ARC1905; Bevacizumab; Ranibizumab; Aflibercept

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IVERIC bio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

IVERIC bio, Inc.

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=26399&tenant=MT_AST_9011

Link to plain language summary of the study on the Trial Results Summaries website

https://www.clinicaltrials.astellas.com/study/OPH2004/

Link to results and other applicable study documents on the Astellas Clinical Trials website

Other Identifiers

OPH2004

Identifier Type: -

Identifier Source: org_study_id