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

March 4, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: Avastin
Avastin 1.25 mg, administered by intravitreal injection
Other Names:
  • Bevacizumab
Drug: Avacincaptad Pegol
Zimura 2 mg, administered by intravitreal injection
Other Names:
  • ARC1905
  • IZERVAY
  • Zimura (previous name)
Experimental: 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.
Drug: Lucentis
Lucentis 0.5 mg, administered by intravitreal injection
Other Names:
  • Ranibizumab
Drug: Avacincaptad Pegol
Zimura 2 mg, administered by intravitreal injection
Other Names:
  • ARC1905
  • IZERVAY
  • Zimura (previous name)
Experimental: 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.
Drug: Eylea
Eylea 2 mg, administered by intravitreal injection
Other Names:
  • Aflibercept
Drug: Avacincaptad Pegol
Zimura 2 mg, administered by intravitreal injection
Other Names:
  • ARC1905
  • IZERVAY
  • Zimura (previous name)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IVERIC bio, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, IVERIC bio, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPH2004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

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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