A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)

October 16, 2025 updated by: IVERIC bio, Inc.

A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to 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 were randomized in a 1:1 ratio to the following monthly treatment groups:

  • Avacincaptad pegol 2 mg
  • Sham

At Month 12, the participants in the avacincaptad pegol 2mg treatment group were re-randomized to receive the study drug either on a monthly basis or on an every other month basis

The participants initially randomized to sham treatment continued with monthly sham administration through Month 23

All participants had a final follow up visit at Month 24

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.
448

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 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

  • Argentina
      • Buenos Aires, Argentina, C1120AAN
        • Instituto Oftalmologico de Buenos Aires
      • Córdoba, Argentina, X5000AAJ
        • Centro Privado de Ojos Romagosa S.A.
      • Córdoba, Argentina, X5000III
        • Instituto Oftalmologico de Cordoba
      • Mendoza, Argentina, M5500GGK
        • Centro Privado de Oftalmologia - OFTAR Mendoza SRL
      • Rosario, Argentina, S2000TC
        • Centro Medico Micro Diagnostico y Microcirugla Ocular
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1116ABA
        • Centro Oftalmológico Dr. Charles SA
      • Buenos Aires, Buenos Aires F.D., Argentina, Cl061AAE
        • Buenos Aires Macula S.A.
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, CP2000
        • Centro Medico Grupo Laser Vision
      • Rosario, Santa Fe Province, Argentina, S2000ANJ
        • Centro de Diagnóstico y Cirugía Ocular "Oftalmólogos Especialistas"
  • Australia
      • East Melbourne, Australia, 3002
        • Royal Victorian Eye & Ear Hospital
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Sydney Eye Hospital
      • Sydney, New South Wales, Australia, 2000
        • Sydney Retina Clinic and Day Surgery
  • Austria
      • Graz, Austria, 8036
        • Medizinische Universitaet Graz - Augenklinik
      • Innsbruck, Austria, 6020
        • Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Augenheilkunde und Optometrie
      • Vienna, Austria, 1090
        • Medical University of Vienna
      • Vienna, Austria, 1140
        • Hanush Hospital
  • Belgium
      • Brussels, Belgium
        • CHU Brugmann
  • Brazil
      • Belo Horizonte, Brazil, 30330
        • Centro de Ensino e Pesquisa do Instituto da Visao (CEPIV)
      • São Paulo, Brazil, 04038-032
        • IPEPO - Instituto da Visao
      • Vila Clementino, Brazil, 04023-062
        • Hospital São Paulo - UNIFESP
  • Canada
      • Ottawa, Canada, K2B 7E9
        • Retina Centre of Ottawa
    • Alberta
      • Calgary, Alberta, Canada, T2H 0C8
        • Calgary Retina Consultants
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z3N9
        • UBC/VGH Eye Care Center
    • Ontario
      • London, Ontario, Canada, N6A4V2
        • St.Joseph's Health Care London
      • Mississauga, Ontario, Canada, L4W 1W9
        • Canadian Centre for Advanced Eye Therapeutics Inc.
      • Ottawa, Ontario, Canada, K1H8L6
        • University of Ottawa Eye Institute
      • Toronto, Ontario, Canada, M5T 2S8
        • University Health Network
  • Colombia
      • Bogotá, Colombia, 110311
        • Fundacion OJlalmologica Nacional - FUNDONAL
    • Antioquia
      • Medellín, Antioquia, Colombia, 050016
        • Clinica de Oftalmologia Sandiego
  • Croatia
      • Osijek, Croatia, 31000
        • Clinical Hospital Center Osijek
  • Czechia
    • Smichov
      • Prague, Smichov, Czechia, 150 00
        • Axon Clinical s.r.o.
  • Estonia
      • Tallinn, Estonia, 11412
        • Dr Kai Noor Silmakabinet
      • Tartu, Estonia, 50406
        • Tartu University Hospital
  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux - Hôpital Pellegrin
      • Créteil, France, 94010
        • Hopital Intercommunal
      • Dijon, France, 21079
        • CHU Bocage
      • Lyon, France, 69004
        • Hopital de la croix rousse
      • Lyon, France, 69002
        • Centre d'ophtalmologie Rabelais
      • Marseille, France, 13008
        • Centre Paradis Monticelli
      • Nantes, France, 44043
        • CHU de Nantes
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75006
        • Centre D'exploration Ophtalmologique De L'odéon
      • Paris, France, 75015
        • Centre Ophtalmologique d'Imagerie et de Laser
      • Paris, France, 75019
        • Fondation Alolphe de Rotschild
      • Saint-Cyr-sur-Loire, France, 37540
        • Centre St Exupery
      • Écully, France, 69130
        • Centre Pole Vision Val d'Ouest
  • Germany
      • Aachen, Germany, 52074
        • RWTH Aachen University
      • Bonn, Germany
        • University of Bonn
      • Cologne, Germany, 50937
        • Augenklinik University Hospital Cologne
      • Göttingen, Germany, 37075
        • University of Göttingen
      • Hamburg, Germany, 20251
        • Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Augenheilkunde Studienzentrum
      • Hanover, Germany, 30625
        • University Eye Hospital, MHH
      • Leipzig, Germany, 04103
        • University clinic Leipzig AÖR
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Munich, Germany, 80336
        • Ludwig-Maximilians-University Munich
      • Munich, Germany, 81675
        • Clinic Rechts der Isar
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
      • Münster, Germany, 48145
        • Augenzentrum am St. Franziskus-Hospital
      • Tübingen, Germany, 72076
        • Universitäts-Augenklinik
  • Hungary
      • Budapest, Hungary, 1133
        • Budapest Retina Associates
      • Budapest, Hungary, 1106
        • Bajcsy Zsilinszky Kórház - Szemészet
      • Budapest, Hungary, H-1085
        • Semmelweis University, Dept of Ophthalmology
      • Budapest, Hungary, 1068
        • Hungarian Military Hospital Center
      • Debrecen, Hungary, H-4032
        • Debrecen University Clinical Center, Dept of Ophthalmology
      • Nyíregyháza, Hungary, 4400
        • Szabolcs-Szatmar-Bereg County Hospital and University Teaching Hospital
      • Pécs, Hungary, H-7621
        • Ganglion Medical Center
      • Szeged, Hungary, H-6720
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
  • Israel
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center
      • Be’er Ya‘aqov, Israel, 70300
        • Shamir Medical Center
      • Haifa, Israel, 3436212
        • Carmel Medical Center
      • Haifa, Israel, 3109601
        • Rambam Medical Centre
      • Holon, Israel, 5822012
        • Edith Wolfson Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital
      • Petah Tikva, Israel, 49100
        • Department of Ophthalmology, Rabin Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center
  • Italy
      • Ancona, Italy, 60126
        • Ospedali Riuniti di Ancona
      • Bologna, Italy, 40138
        • A.O.U. Policlinico Sant'Orsola-Malpighi
      • Chieti, Italy, 66100
        • Ospedale Clinicizzato Universita di Chieti "Ss Annunziata"
      • Ferrara, Italy, 44124
        • Nuovo Arcispedale Sant' Anna (A.O.U. di Ferrara)
      • Florence, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Milan, Italy, 20132
        • Irccs Ospedale San Raffaele
      • Milan, Italy, 20157
        • Ospedale Luigi Sacco
      • Milan, Italy, 20122
        • Ospedale Maggiore Policlinico Milano
      • Naples, Italy, 80131
        • AOU Universita degli Studi della Campania Luigi Vanvitelli UOC Oculistica
      • Padua, Italy, 35128
        • Azienda Ospedaliera di Padova Unità Operativa Complessa di Clinica Oculistica
      • Pisa, Italy, 56126
        • University of Pisa
      • Roma, Italy, 00133
        • Fondazione PTV
      • Roma, Italy, 00198
        • Fondazione GB Bietti IRCCS
      • Udine, Italy, 33100
        • Azienda Sanitaria Universitaria Integrata
  • Latvia
      • Riga, Latvia, LV-1002
        • Pauls Stradinis Clinical University Hospital
  • Poland
      • Bydgoszcz, Poland, 85-631
        • Klinika Okulistyczna OFT ALMIKA Sp. z o. o.
      • Lodz, Poland, 91-485
        • Medical Center Julianów
      • Tarnowskie Góry, Poland, 42-600
        • Caminomed
      • Wroclaw, Poland, 50-556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
  • Spain
      • Barcelona, Spain, 08022
        • Institut Català de Retina
      • Barcelona, Spain, 08021
        • Clinica de Oftalmologia Barraquer
      • Barcelona, Spain, 08022
        • Institut de la Macula
      • Barcelona, Spain, 08195
        • VOR - Hospital General de Catalunya
      • Bilbao, Spain, 48010
        • Instituto Clinico Quirurgico de Oftalmologia
      • Córdoba, Spain, CP 14012
        • Hospital La Arruzafa
      • Majadahonda, Spain, 28222
        • H.U. Puerta de Hierro-Majadahonda
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
      • Santiago de Compostela, Spain, 15706
        • Instituto Oftalmológico Gómez-Ulla
      • Valencia, Spain, 46100
        • IMED Servicio Oftalmología
      • Valladolid, Spain, 47012
        • Rio Hortega University Hospital
      • Zaragoza, Spain, 50009
        • Hospital Clínico Universitario "Lozano Blesa"
  • United Kingdom
      • Hull, United Kingdom, HU3 2JZ
        • Hull University Teaching Hospitals NHS Trust
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center
      • Fresno, California, United States, 93720
        • Eye Medical Center of Fresno
      • Fullerton, California, United States, 92835
        • Retina Consultants of Orange County
      • La Jolla, California, United States, 92093
        • University of California, San Diego
      • Los Angeles, California, United States, 90095
        • Jules Stein Eye Institute/David Geffen School of Medicine
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates
      • Oxnard, California, United States, 93036
        • California Retina Consultants
      • Palm Desert, California, United States, 92211
        • Southern California Desert Retina Consultants
      • Pasadena, California, United States, 91105
        • Doheny Eye Center, UCLA
      • Redlands, California, United States, 92374
        • Retina Consultants of Southern California
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group, Inc.
      • Santa Ana, California, United States, 92705
        • Orange County Retinal Medical Group
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado, P.C.
      • Lakewood, Colorado, United States, 80228
        • Colorado Retina Associates
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Connecticut Eye Consultants, P.C.
      • Waterford, Connecticut, United States, 06385
        • Retina Group of New England, PC
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Florida Eye Clinic
      • Deerfield Beach, Florida, United States, 33064
        • Rand Eye Institute
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute
      • Fort Myers, Florida, United States, 33907
        • Retina Health Center
      • Gainesville, Florida, United States, 32607
        • VitreoRetinal Associates, P.A.
      • Melbourne, Florida, United States, 32901
        • Florida Eye Associates
      • Miami, Florida, United States, 33136
        • University of Miami-Bascom Palmer Eye Institute
      • Palm Beach Gardens, Florida, United States, 33410
        • Retina Care Specialists
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Sarasota, Florida, United States, 34233
        • Retina Associates of Sarasota
      • St. Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida
      • Stuart, Florida, United States, 34994
        • East Florida Eye Institute
      • Tallahassee, Florida, United States, 32308
        • Southern Vitreoretinal Associates, PL
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macula Disease
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
      • Marietta, Georgia, United States, 30060
        • Georgia Retina, P.C.
    • Hawaii
      • ‘Aiea, Hawaii, United States, 96701
        • Retina Consultants of Hawaii, Inc
    • Illinois
      • Lemont, Illinois, United States, 60439
        • University Retina and Macula Associates, PC
      • Peoria, Illinois, United States, 61615
        • Illinois Eye Center
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Midwest Eye Institute
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Eye Clinic
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • Retina Associates, LLC
      • Wichita, Kansas, United States, 67214
        • Vitreo Retinal Consultants & Surgeons
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • The Retina Care Center
      • Chevy Chase, Maryland, United States, 20815
        • The Retina Group of Washington
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
      • Springfield, Massachusetts, United States, 01107
        • Retina Research Institute at New England Retinal Consultants
      • Worcester, Massachusetts, United States, 01605
        • UMASS Memorial Eye Center
      • Worcester, Massachusetts, United States, 01605
        • Vitreoretinal Associates, PC
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants, P.C.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Retina Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • St. Louis University
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Retina Consultants of Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Retina Center of New Jersey, LLC
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Vitreoretinal Consultant
      • Liverpool, New York, United States, 13088
        • Retina Vitreous Surgeons of Central New York, PC
      • New York, New York, United States, 10022
        • Vitreous Retina Macula Consultants of New York (VRMNY)
      • Oceanside, New York, United States, 11572
        • OCLI
      • Rochester, New York, United States, 14620
        • Retina Associates of Western NY, PC
      • Troy, New York, United States, 12180
        • Ophthalmic Consultants of the Capital Region
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Western Carolina Retinal Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
    • Oregon
      • Ashland, Oregon, United States, 97520
        • Retina and Vitreous Center of Southern Oregon
      • Portland, Oregon, United States, 97239
        • Casey Eye Institute
      • Portland, Oregon, United States, 97225
        • EyeHealth Northwest
      • Portland, Oregon, United States, 97221
        • Retina Northwest, PC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Scheie Eye Institute, University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina
      • West Mifflin, Pennsylvania, United States, 15122
        • Associates in Ophthalmology, Ltd
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Retina Research of Beaufort, LLC
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute
      • Mt. Pleasant, South Carolina, United States, 29464
        • Carolina Macula and Retina
      • West Columbia, South Carolina, United States, 29169
        • Palmetto Retina Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Southeastern Retina Associates, PC
      • Knoxville, Tennessee, United States, 37922
        • Southeastern Retina Associates, PC
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Amarillo, Texas, United States, 79106
        • Southwest Retina Specialists
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Dallas, Texas, United States, 75231
        • Retina Foundation of the Southwest
      • Houston, Texas, United States, 77025
        • Retina and Vitreous of Texas, PLLC
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
      • Southlake, Texas, United States, 76092
        • Retina Center Of Texas
      • The Woodlands, Texas, United States, 77384
        • Retinal Consultants of Houston
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah, John A. Moran Eye Center
      • Salt Lake City, Utah, United States, 84107
        • Rocky Mountain Retina Consultants
      • Salt Lake City, Utah, United States, 84107
        • Retinal Associates of Utah
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Wagner Macular & Retina Center
      • Richmond, Virginia, United States, 23235
        • Retina Institute of Virginia
      • Roanoke, Virginia, United States, 24018
        • Vistar Eye Center
    • Washington
      • Bellevue, Washington, United States, 98004
        • Pacific Northwest Retina
      • Silverdale, Washington, United States, 98383
        • Retina Center NW, PLLC

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:

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

Exclusion Criteria:

  • Any prior treatment for AMD (dry or wet) 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 3 months of trial entry.
  • Any prior thermal laser in the macular region, regardless of indication
  • Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 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.
Experimental: Avacincaptad Pegol
Participants received avacincaptad pegol (ACP) 2 milligram (mg)/eye via intravitreal (IVT) injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2).
Drug: Avacincaptad Pegol
Avacincaptad Pegol Intravitreal Injection
Other Names:
  • IZERVAY
  • Zimura (previous name)
Sham Comparator: Sham
Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham administration from month 12 through month 23 (Year 2).
Drug: Sham
Sham Administration (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection)
Experimental: Avacincaptad pegol and Sham
Participants who received ACP 2mg monthly through Month 11 (Year 1) were re-randomized at month 12, to receive ACP 2 mg/eye via IVT injections every other month at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22.
Drug: Avacincaptad Pegol
Avacincaptad Pegol Intravitreal Injection
Other Names:
  • 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
The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12
Time Frame: Baseline to month 12
GA was associated with age-related macular degeneration (AMD) and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least squares mean used to determine mean rate of change in GA growth (slope) was measured by FAF. LS mean & SE were based on square-root transformation.
Baseline to month 12
The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24
Time Frame: Baseline to month 24
GA was associated with AMD and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least square mean rate of GA growth (slope) was measured by FAF. LS mean & SE were based on untransformed data.
Baseline to month 24

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 (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months
Time Frame: Baseline and month 24
BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS Visual Acuity Score (VAS) is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Baseline and month 24
Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months
Time Frame: Baseline and month 24
BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. LL BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart.
Baseline and month 24
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months
Time Frame: Baseline, months 6, 12, and 18
The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales.
Baseline, months 6, 12, and 18
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months
Time Frame: Baseline and month 24
The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales.
Baseline and month 24
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale
Time Frame: Baseline up to month 24
The National Eye Institute VFQ-25 measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively.Categorical one-level loss in each item was defined as decline of one or more levels at Month 24 on the original scale from Baseline (equivalently 20 points for general vision and 25 points for other vision items in a 0 to 100 scale).
Baseline up to month 24
Time to Persistent Vision Loss
Time Frame: Baseline up to month 24
Vision loss event was defined as a loss of ≥ 15 letters (equivalent to a loss of 3 lines on the ETDRS chart) in BCVA from Baseline measured at any two or more consecutive visits up to Month 24. These parameters were chosen as a 3-line BCVA loss (equivalent to doubling of visual angle) is widely recognized as a significant deterioration in vision and a minimum of two consecutive visits was representative of persistent disease progression. BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS was defined as the number of letters read on the ETDRS chart. Min and max possible scores are 0-100. A higher score represents better visual functioning. Kaplan-Meier method was used for analysis. Participants with an event were reported and not the median time to event.
Baseline up to month 24

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.
June 22, 2020

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.
July 25, 2022

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.
August 22, 2023

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).
May 12, 2020

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.
June 15, 2020

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.
June 17, 2020

Study Record Updates

Last Update Posted (Estimated)

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.
October 21, 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.
October 16, 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.
October 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.
  • ISEE2008

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/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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