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

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • 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

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
Intervention / Treatment
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

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

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

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)

December 15, 2015

Primary Completion (Actual)

September 26, 2019

Study Completion (Actual)

April 23, 2020

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimated)

February 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

May 25, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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