Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

May 25, 2025 updated by: IVERIC bio, Inc.

A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Study Overview

Status

Status

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

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.

Detailed Description

Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.

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.
286

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
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Osijek, Croatia, 31000
        • Clinical Hospital Center Osijek
  • Czechia
      • Brno, Czechia, 62500
        • Fakultni nemocnice Brno
      • Hradec Králové, Czechia, 50005
        • Faculty Hospital Hradec Králové
      • Olomouc, Czechia, 77900
        • Fakultni Nemocnice Olomouc
      • Praha, Czechia, 15000
        • Axon Clinical sro
  • Estonia
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital
      • Tallinn, Estonia, 11412
        • Dr.Kai Noor Eye Clinic
  • Hungary
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1145
      • Budapest, Hungary, 1106
      • Budapest, Hungary, 1133
      • Budapest, Hungary, 1076
        • Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet
      • Debrecen, Hungary, 4012
      • Pecs, Hungary, 7621
      • Szeged, Hungary, 6720
      • Veszprém, Hungary, 8200
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Petah tikva, Israel, 4941492
        • Rabin Medical Center
      • Reẖovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel-Aviv Sourasky Medical Center
  • Latvia
      • Riga, Latvia, LV1002
        • Pauls Stradins Clinical University Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
      • Tucson, Arizona, United States, 85704
      • Tucson, Arizona, United States, 85710
    • California
      • Campbell, California, United States, 95008
      • Fresno, California, United States, 93720
      • Fullerton, California, United States, 92835
      • La Jolla, California, United States, 92093
      • Mountain View, California, United States, 94040
      • Redlands, California, United States, 92374
      • Sacramento, California, United States, 95819
      • Sacramento, California, United States, 95841
      • Santa Ana, California, United States, 92705
    • Colorado
      • Denver, Colorado, United States, 80210
    • Florida
      • Altamonte Springs, Florida, United States, 32701
      • Boynton Beach, Florida, United States, 33426
      • Melbourne, Florida, United States, 32901
      • Saint Petersburg, Florida, United States, 33711
      • Stuart, Florida, United States, 34994
      • Winter Haven, Florida, United States, 33880
    • Georgia
      • Augusta, Georgia, United States, 30909
      • Marietta, Georgia, United States, 30060
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Retina Consultants Of Hawaii
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Kansas
      • Shawnee Mission, Kansas, United States, 66204
      • Wichita, Kansas, United States, 67214
    • Maryland
      • Baltimore, Maryland, United States, 21209
      • Chevy Chase, Maryland, United States, 20815
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Springfield, Massachusetts, United States, 01107
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
    • Nevada
      • Henderson, Nevada, United States, 89052
      • Reno, Nevada, United States, 89502
    • New York
      • Rochester, New York, United States, 14620
      • Syracuse, New York, United States, 13224
    • North Carolina
      • Asheville, North Carolina, United States, 28803
      • Charlotte, North Carolina, United States, 28210
      • Hickory, North Carolina, United States, 28602
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Cleveland, Ohio, United States, 44130
      • Cleveland, Ohio, United States, 44136
    • Oregon
      • Portland, Oregon, United States, 97221
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
      • West Mifflin, Pennsylvania, United States, 15122
    • South Carolina
      • Ladson, South Carolina, United States, 29456
      • West Columbia, South Carolina, United States, 29169
    • Texas
      • Abilene, Texas, United States, 79606
      • Amarillo, Texas, United States, 79106
      • Austin, Texas, United States, 78705
      • Grapevine, Texas, United States, 76051
      • Houston, Texas, United States, 77030
      • The Woodlands, Texas, United States, 77384
      • Willow Park, Texas, United States, 76087
    • Utah
      • Salt Lake City, Utah, United States, 84132
      • Salt Lake City, Utah, United States, 84107
    • Virginia
      • Richmond, Virginia, United States, 23235

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants of either gender aged ≥ 50 years
  • Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria:

  • Evidence of Choroidal Neovascularization (CNV)
  • GA secondary to any condition other than AMD
  • Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
  • Any intraocular surgery or thermal laser within three (3) months of trial entry
  • Any prior thermal laser in the macular region, regardless of indication
  • Any ocular or periocular infection in the twelve (12) weeks
  • Previous therapeutic radiation in the region of the study eye
  • Any sign of diabetic retinopathy in either eye

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: Double

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.
Sham Comparator: Sham [Part 1]
Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
Other: Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.
Sham Comparator: Sham (Sham+Sham) [Part 2]
Participants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
Other: Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.
Experimental: Avacincaptad Pegol 1 mg [Part 1]
Participants received 1 mg of Avacincaptad Pegol in the study eye administered via IVT injection (50 µL) on Day 1 and monthly up to 18 months.
Drug: Avacincaptad Pegol
Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection
Other Names:
  • ARC1905
  • IZERVAY
  • Zimura (previous name)
Experimental: Avacincaptad Pegol 2 mg [Part 1]
Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) on Day 1 and monthly up to 18 months.
Drug: Avacincaptad Pegol
Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection
Other Names:
  • ARC1905
  • IZERVAY
  • Zimura (previous name)
Experimental: Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]
Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.
Other: Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.
Drug: Avacincaptad Pegol
Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection
Other Names:
  • ARC1905
  • IZERVAY
  • Zimura (previous name)
Experimental: Avacincaptad Pegol 4 mg (Avacincaptad Pegol 2mg+Avacincaptad Pegol 2mg) [Part 2]
Participants received 4 mg of Avacincaptad Pegol in the study eye administered via two consecutive IVT injections (2 x 100 µL) on Day 1 and monthly up to 18 months.
Drug: Avacincaptad Pegol
Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) 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
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence
Time Frame: Baseline and 12 months
The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.
Baseline and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters
Time Frame: Baseline and 12 months
The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study [ETDRS] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.
Baseline and 12 months
Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters
Time Frame: Baseline and 12 months
The least squares mean change in low luminance (LL) BCVA from baseline to Month 12 was measured using ETDRS letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.
Baseline and 12 months

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.

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.

General Publications

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.
December 15, 2015

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.
September 26, 2019

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 23, 2020

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).
February 16, 2016

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.
February 18, 2016

First Posted (Estimated)

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.
February 19, 2016

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.
June 10, 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.
May 25, 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.
May 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.
  • OPH2003
  • 2015-003991-56 (EudraCT Number)

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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