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Geographic AtrophyPhase 2/3NCT02686658

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

A Phase 2/3 study testing Avacincaptad Pegol in people with Geographic Atrophy and Dry Age-Related Macular Degeneration, run by IVERIC bio, Inc. at 78 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Avacincaptad Pegol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
286 participants
Where
78 sitesin 7 countries
Study dates
15 Dec 2015to 23 Apr 2020
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

78 sites in 7 countries.

78 sites in 7 countries

United States55 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Study site

    Abilene, Texas, 79606

  • Study site

    Altamonte Springs, Florida, 32701

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Austin, Texas, 78705

  • Study site

    Baltimore, Maryland, 21209

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Campbell, California, 95008

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Chevy Chase, Maryland, 20815

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Cleveland, Ohio, 44130

  • Study site

    Cleveland, Ohio, 44136

  • Study site

    Denver, Colorado, 80210

  • Study site

    Fresno, California, 93720

  • Study site

    Fullerton, California, 92835

  • Study site

    Grand Rapids, Michigan, 49546

  • Study site

    Grapevine, Texas, 76051

  • Study site

    Henderson, Nevada, 89052

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Houston, Texas, 77030

  • Study site

    La Jolla, California, 92093

  • Study site

    Ladson, South Carolina, 29456

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Mountain View, California, 94040

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85053

  • Study site

    Portland, Oregon, 97221

  • Study site

    Redlands, California, 92374

  • Study site

    Reno, Nevada, 89502

  • Study site

    Richmond, Virginia, 23235

  • Study site

    Rochester, New York, 14620

  • Study site

    Sacramento, California, 95819

  • Study site

    Sacramento, California, 95841

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    Salt Lake City, Utah, 84132

  • Study site

    Santa Ana, California, 92705

  • Study site

    Shawnee Mission, Kansas, 66204

  • Study site

    Springfield, Massachusetts, 01107

  • Study site

    St. Petersburg, Florida, 33711

  • Study site

    Stuart, Florida, 34994

  • Study site

    Syracuse, New York, 13224

  • Study site

    The Woodlands, Texas, 77384

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tucson, Arizona, 85710

  • Study site

    West Columbia, South Carolina, 29169

  • Study site

    West Des Moines, Iowa, 50266

  • Study site

    West Mifflin, Pennsylvania, 15122

  • Study site

    Wichita, Kansas, 67214

  • Study site

    Willow Park, Texas, 76087

  • Study site

    Winter Haven, Florida, 33880

Other trials in United States

Hungary9 sites

  • Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet

    Budapest, 1076

  • Study site

    Budapest, 1083

  • Study site

    Budapest, 1106

  • Study site

    Budapest, 1133

  • Study site

    Budapest, 1145

  • Study site

    Debrecen, 4012

  • Study site

    Pécs, 7621

  • Study site

    Szeged, 6720

  • Study site

    Veszprém, 8200

Other trials in Hungary

Israel6 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Hadassah University Hospital

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Czechia4 sites

  • Fakultni Nemocnice Brno

    Brno, 62500

  • Faculty Hospital Hradec Kralove

    Hradec Králové, 50005

  • Fakultni nemocnice Olomouc

    Olomouc, 77900

  • Axon Clinical SRO

    Prague, 15000

Other trials in Czechia

Estonia2 sites

  • East Tallinn Central Hospital

    Tallinn, 10138

  • Dr.Kai Noor Eye Clinic

    Tallinn, 11412

Other trials in Estonia

Croatia1 site

  • Clinical hospital center Osijek

    Osijek, 31000

Other trials in Croatia

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga, LV1002

Other trials in Latvia

About this study

Official title: 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).

Read the detailed description

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

Being tested
Avacincaptad Pegol, Sham
Keywords
Geographic Atrophy (GA), Dry age-related macular degeneration, AMD, Zimura (previous name), Anti-inflammatory, complement factor C5 inhibitor, ARC1905, avacincaptad pegol
Medical subject headings
Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avacincaptad PegolDrug

    Also called Zimura (previous name), IZERVAY, ARC1905

    Avacincaptad Pegol 20 mg/mL solution for intravitreal (IVT) injection

  • ShamOther

    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.

Study groups in NCT02686658
Study groupRoleWhat they receive
Avacincaptad Pegol 1 mg [Part 1]ExperimentalParticipants 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.
Receives: Drug: Avacincaptad Pegol
Avacincaptad Pegol 2 mg [Part 1]ExperimentalParticipants 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.
Receives: Drug: Avacincaptad Pegol
Sham [Part 1]Sham comparatorParticipants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
Receives: Other: Sham
Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]ExperimentalParticipants 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.
Receives: Drug: Avacincaptad Pegol; Other: Sham
Avacincaptad Pegol 4 mg (Avacincaptad Pegol 2mg+Avacincaptad Pegol 2mg) [Part 2]ExperimentalParticipants 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.
Receives: Drug: Avacincaptad Pegol
Sham (Sham+Sham) [Part 2]Sham comparatorParticipants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence

    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.

    Measured: Baseline and 12 months

Secondary outcomes (2)

  1. Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters

    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.

    Measured: Baseline and 12 months

  2. Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters

    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.

    Measured: Baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2016 (estimated)
  2. Study start15 Dec 2015
  3. Primary completion26 Sep 2019
  4. Study completion23 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02686658
Sponsor's protocol ID
OPH2003
Other IDs
2015-003991-56, 2015
Status last verified
May 2025
First submitted
16 Feb 2016
Last updated
10 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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/.

Publications

  • Jaffe GJ, Westby K, Csaky KG, Mones J, Pearlman JA, Patel SS, Joondeph BC, Randolph J, Masonson H, Rezaei KA. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmology. 2021 Apr;128(4):576-586. doi: 10.1016/j.ophtha.2020.08.027. Epub 2020 Sep 1.

    PubMed 32882310

  • Corradetti G, Karamat A, Srinivas S, Lindenberg S, Velaga SB, Corvi F, Attiku Y, Nittala MG, Desai D, Zhu L, Abulon D, Sadda SR. Progression to complete retinal pigment epithelium and outer retinal atrophy (cRORA): post hoc analysis of the GATHER1 trial. Graefes Arch Clin Exp Ophthalmol. 2025 Mar;263(3):669-677. doi: 10.1007/s00417-024-06676-7. Epub 2024 Nov 14.

    PubMed 39538001

  • Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.

    PubMed 37314061

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Avacincaptad Pegol in people with Geographic Atrophy and Dry Age-Related Macular Degeneration, run by IVERIC bio, Inc. at 78 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Hungary, Israel, Czechia, Estonia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02686658, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.

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