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

NCT05571267 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: OPH2004
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

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

Keywords

Neovascular age-related macular degeneration (NVAMD)

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Month 18

Study Arms (3)

Avacincaptad Pegol and Avastin

EXPERIMENTAL

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.

Drug: Avacincaptad Pegol; Drug: Avastin

Avacincaptad Pegol and Lucentis

EXPERIMENTAL

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.

Drug: Avacincaptad Pegol; Drug: Lucentis

Avacincaptad Pegol and Eylea

EXPERIMENTAL

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.

Drug: Avacincaptad Pegol; Drug: Eylea

Interventions

Avacincaptad Pegol DRUG

Zimura 2 mg, administered by intravitreal injection

Also known as: Zimura (previous name), IZERVAY, ARC1905

Avacincaptad Pegol and Avastin; Avacincaptad Pegol and Eylea; Avacincaptad Pegol and Lucentis

Avastin DRUG

Avastin 1.25 mg, administered by intravitreal injection

Also known as: Bevacizumab

Avacincaptad Pegol and Avastin

Lucentis DRUG

Lucentis 0.5 mg, administered by intravitreal injection

Also known as: Ranibizumab

Avacincaptad Pegol and Lucentis

Eylea DRUG

Eylea 2 mg, administered by intravitreal injection

Also known as: Aflibercept

Avacincaptad Pegol and Eylea

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• IVERIC bio, Inc.: lead

Related Links

• Link to plain language summary of the study on the Trial Results Summaries website
• Link to results and other applicable study documents on the Astellas Clinical Trials website

MeSH Terms

Interventions

Bevacizumab; Ranibizumab; aflibercept

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Following the Sponsor's reassessment of the Zimura development program, enrollment was stopped in this trial as the Sponsor determined that they would initiate a new Zimura wet AMD trial, the OPH2007 trial, for treatment-naïve patients. Therefore, a total of two patients were screened, one of whom was a screen failure. Thus, only one patient was enrolled into Study OPH2004.

Results Point of Contact

• Title: Medical Director
• Organization: IVERIC Bio, Inc.

info@ivericbio.com

609-474-6755

Study Officials

• Medical Director

  IVERIC bio, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 7, 2022
• Study Start: October 20, 2016
• Primary Completion: April 24, 2018
• Study Completion: April 24, 2018
• Last Updated: March 13, 2025
• Results First Posted: April 3, 2023

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share