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

February 20, 2024 updated by: IVERIC bio, Inc.

A Phase 2A Randomized Open-Label Controlled Trial to Assess the Safety of Zimura™ (Anti-C5 Aptamer) Administered in Combination With Anti-VEGF Therapy in Treatment Experienced Patients With Neovascular Age-Related Macular Degeneration

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zimura and Avastin
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura 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 Zimura.
Drug: Zimura
Zimura 2 mg, administered by intravitreal injection
Other Names:
  • Avacincaptad Pegol
  • ARC1905
Drug: Avastin
Avastin 1.25 mg, administered by intravitreal injection
Other Names:
  • Bevacizumab
Experimental: Zimura and Lucentis
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura 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 Zimura.
Drug: Zimura
Zimura 2 mg, administered by intravitreal injection
Other Names:
  • Avacincaptad Pegol
  • ARC1905
Drug: Lucentis
Lucentis 0.5 mg, administered by intravitreal injection
Other Names:
  • Ranibizumab
Experimental: Zimura and Eylea
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura 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 Zimura.
Drug: Zimura
Zimura 2 mg, administered by intravitreal injection
Other Names:
  • Avacincaptad Pegol
  • ARC1905
Drug: Eylea
Eylea 2 mg, administered by intravitreal injection
Other Names:
  • Aflibercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With >0 Letter Loss
Time Frame: Month 12

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
Time Frame: Month 18

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
Time Frame: Month 12

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
Time Frame: Month 18

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
Time Frame: Month 12

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
Time Frame: Month 18

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVERIC bio, Inc.

Investigators

  • Study Director: Medical Director, IVERIC bio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2016

Primary Completion (Actual)

April 24, 2018

Study Completion (Actual)

April 24, 2018

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPH2004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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