AzTrials
AzTrials

Geographic AtrophyPhase 3NCT04435366

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

A Phase 3 study testing Avacincaptad Pegol in people with Geographic Atrophy and Macular Degeneration, run by IVERIC bio, Inc. at 205 sites in 20 countries.

Completed

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

Official record
Search all trials

Trial summary

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) Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Geographic Atrophy, Macular Degeneration
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
448 participants
Where
205 sitesin 20 countries
Study dates
22 Jun 2020to 22 Aug 2023
Phase
Phase 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

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

Who cannot join

  • 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

Trial locations and contacts

205 sites in 20 countries.

205 sites in 20 countries

United States96 sites

  • Retina Consultants of Hawaii, Inc

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Florida Eye Clinic

    Altamonte Springs, Florida, 32701

  • Southwest Retina Specialists

    Amarillo, Texas, 79106

  • Western Carolina Retinal Associates

    Asheville, North Carolina, 28803

  • Retina and Vitreous Center of Southern Oregon

    Ashland, Oregon, 97520

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • University of Colorado

    Aurora, Colorado, 80045

  • Austin Retina Associates

    Austin, Texas, 78705

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Retina Research of Beaufort, LLC

    Beaufort, South Carolina, 29902

  • Pacific Northwest Retina

    Bellevue, Washington, 98004

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Retina Center of New Jersey, LLC

    Bloomfield, New Jersey, 07003

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • The Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Retina Consultants of Southern Colorado, P.C.

    Colorado Springs, Colorado, 80909

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231

  • Connecticut Eye Consultants, P.C.

    Danbury, Connecticut, 06810

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • Retina Health Center

    Fort Myers, Florida, 33907

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Eye Medical Center of Fresno

    Fresno, California, 93720

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • VitreoRetinal Associates, P.A.

    Gainesville, Florida, 32607

  • Long Island Vitreoretinal Consultant

    Great Neck, New York, 11021

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Retina Consultants of Nevada

    Henderson, Nevada, 89052

  • Retina and Vitreous of Texas, PLLC

    Houston, Texas, 77025

  • Midwest Eye Institute

    Indianapolis, Indiana, 46290

  • Southeastern Retina Associates, PC

    Johnson City, Tennessee, 37604

  • Southeastern Retina Associates, PC

    Knoxville, Tennessee, 37922

  • University of California, San Diego

    La Jolla, California, 92093

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • Colorado Retina Associates

    Lakewood, Colorado, 80228

  • University Retina and Macula Associates, PC

    Lemont, Illinois, 60439

  • Retina Associates, LLC

    Lenexa, Kansas, 66215

  • Retina Vitreous Surgeons of Central New York, PC

    Liverpool, New York, 13088

  • Jules Stein Eye Institute/David Geffen School of Medicine

    Los Angeles, California, 90095

  • Georgia Retina, P.C.

    Marietta, Georgia, 30060

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • University of Miami-Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • Retina Center

    Minneapolis, Minnesota, 55404

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Carolina Macula and Retina

    Mt. Pleasant, South Carolina, 29464

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Vitreous Retina Macula Consultants of New York (VRMNY)

    New York, New York, 10022

  • Wagner Macular & Retina Center

    Norfolk, Virginia, 23502

  • OCLI

    Oceanside, New York, 11572

  • California Retina Consultants

    Oxnard, California, 93036

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • Southern California Desert Retina Consultants

    Palm Desert, California, 92211

  • Doheny Eye Center, UCLA

    Pasadena, California, 91105

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Illinois Eye Center

    Peoria, Illinois, 61615

  • Scheie Eye Institute, University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107

  • Retina Northwest, PC

    Portland, Oregon, 97221

  • EyeHealth Northwest

    Portland, Oregon, 97225

  • Casey Eye Institute

    Portland, Oregon, 97239

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Vistar Eye Center

    Roanoke, Virginia, 24018

  • Retina Associates of Western NY, PC

    Rochester, New York, 14620

  • Associated Retinal Consultants, P.C.

    Royal Oak, Michigan, 48073

  • Retinal Consultants Medical Group, Inc.

    Sacramento, California, 95825

  • Retinal Associates of Utah

    Salt Lake City, Utah, 84107

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah, 84107

  • University of Utah, John A. Moran Eye Center

    Salt Lake City, Utah, 84132

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Orange County Retinal Medical Group

    Santa Ana, California, 92705

  • Retina Associates of Sarasota

    Sarasota, Florida, 34233

  • Retina Center NW, PLLC

    Silverdale, Washington, 98383

  • Retina Center of Texas

    Southlake, Texas, 76092

  • Retina Research Institute at New England Retinal Consultants

    Springfield, Massachusetts, 01107

  • St. Louis University

    St Louis, Missouri, 63110

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711

  • East Florida Eye Institute

    Stuart, Florida, 34994

  • Southern Vitreoretinal Associates, PL

    Tallahassee, Florida, 32308

  • Retinal Consultants of Houston

    The Woodlands, Texas, 77384

  • Ophthalmic Consultants of the Capital Region

    Troy, New York, 12180

  • Retina Group of New England, PC

    Waterford, Connecticut, 06385

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Associates in Ophthalmology, Ltd

    West Mifflin, Pennsylvania, 15122

  • Vitreo Retinal Consultants & Surgeons

    Wichita, Kansas, 67214

  • Strategic Clinical Research Group

    Willow Park, Texas, 76087

  • Center for Retina and Macula Disease

    Winter Haven, Florida, 33880

  • UMASS Memorial Eye Center

    Worcester, Massachusetts, 01605

  • Vitreoretinal Associates, PC

    Worcester, Massachusetts, 01605

Other trials in United States

Germany14 sites

  • RWTH Aachen University

    Aachen, 52074

  • University of Bonn

    Bonn

  • Augenklinik University Hospital Cologne

    Cologne, 50937

  • University of Göttingen

    Göttingen, 37075

  • Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Augenheilkunde Studienzentrum

    Hamburg, 20251

  • University Eye Hospital, MHH

    Hanover, 30625

  • University clinic Leipzig AÖR

    Leipzig, 04103

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Ludwig-Maximilians-University Munich

    Munich, 80336

  • Clinic Rechts der Isar

    Munich, 81675

  • Augenzentrum am St. Franziskus-Hospital

    Münster, 48145

  • Universitätsklinikum Münster

    Münster, 48149

  • Universitäts-Augenklinik

    Tübingen, 72076

Other trials in Germany

Italy14 sites

  • Ospedali Riuniti di Ancona

    Ancona, 60126

  • A.O.U. Policlinico Sant'Orsola-Malpighi

    Bologna, 40138

  • Ospedale Clinicizzato Universita di Chieti "Ss Annunziata"

    Chieti, 66100

  • Nuovo Arcispedale Sant' Anna (A.O.U. di Ferrara)

    Ferrara, 44124

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134

  • Ospedale Maggiore Policlinico Milano

    Milan, 20122

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Ospedale Luigi Sacco

    Milan, 20157

  • AOU Universita degli Studi della Campania Luigi Vanvitelli UOC Oculistica

    Naples, 80131

  • Azienda Ospedaliera di Padova Unità Operativa Complessa di Clinica Oculistica

    Padova, 35128

  • University of Pisa

    Pisa, 56126

  • Fondazione PTV

    Roma, 00133

  • Fondazione GB Bietti IRCCS

    Roma, 00198

  • Azienda Sanitaria Universitaria Integrata

    Udine, 33100

Other trials in Italy

France13 sites

  • CHU de Bordeaux - Hopital Pellegrin

    Bordeaux, 33000

  • Hopital Intercommunal

    Créteil, 94010

  • CHU Bocage

    Dijon, 21079

  • Centre Pole Vision Val d'Ouest

    Écully, 69130

  • Centre d'ophtalmologie Rabelais

    Lyon, 69002

  • Hopital de la Croix Rousse

    Lyon, 69004

  • Centre Paradis Monticelli

    Marseille, 13008

  • CHU de Nantes

    Nantes, 44043

  • Centre d'exploration ophtalmologique de l'Odeon

    Paris, 75006

  • Hôpital Lariboisière

    Paris, 75010

  • Centre Ophtalmologique d'Imagerie et de Laser

    Paris, 75015

  • Fondation Alolphe de Rotschild

    Paris, 75019

  • Centre St Exupery

    Saint-Cyr-sur-Loire, 37540

Other trials in France

Spain12 sites

  • Clinica de Oftalmologia Barraquer

    Barcelona, 08021

  • Institut Catala de Retina

    Barcelona, 08022

  • Institut de la Macula

    Barcelona, 08022

  • VOR - Hospital General de Catalunya

    Barcelona, 08195

  • Instituto Clinico Quirurgico de Oftalmologia

    Bilbao, 48010

  • Hospital La Arruzafa

    Córdoba, CP 14012

  • H.U. Puerta de Hierro-Majadahonda

    Majadahonda, 28222

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Instituto Oftalmologico Gomez-Ulla

    Santiago de Compostela, 15706

  • IMED Servicio Oftalmología

    Valencia, 46100

  • Rio Hortega University Hospital

    Valladolid, 47012

  • Hospital Clínico Universitario "Lozano Blesa"

    Zaragoza, 50009

Other trials in Spain

Argentina9 sites

  • Centro Oftalmológico Dr. Charles SA

    Buenos Aires, Buenos Aires F.D., C1116ABA

  • Buenos Aires Macula S.A.

    Buenos Aires, Buenos Aires F.D., Cl061AAE

  • Instituto Oftalmológico de Buenos Aires

    Buenos Aires, C1120AAN

  • Centro Privado de Ojos Romagosa S.A.

    Córdoba, X5000AAJ

  • Instituto Oftalmológico de Córdoba

    Córdoba, X5000III

  • Centro Privado de Oftalmologia - OFTAR Mendoza SRL

    Mendoza, M5500GGK

  • Centro Médico Grupo Laser Visión

    Rosario, Santa Fe Province, CP2000

  • Centro de Diagnóstico y Cirugía Ocular "Oftalmólogos Especialistas"

    Rosario, Santa Fe Province, S2000ANJ

  • Centro Medico Micro Diagnostico y Microcirugla Ocular

    Rosario, S2000TC

Other trials in Argentina

Israel9 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Shamir Medical Center

    Be’er Ya‘aqov, 70300

  • Rambam Medical Centre

    Haifa, 3109601

  • Carmel Medical Center

    Haifa, 3436212

  • Edith Wolfson Medical Center

    Holon, 5822012

  • Hadassah University Hospital

    Jerusalem, 91120

  • Department of Ophthalmology, Rabin Medical Center

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

  • Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Hungary8 sites

  • Hungarian Military Hospital Center

    Budapest, 1068

  • Bajcsy Zsilinszky Kórház - Szemészet

    Budapest, 1106

  • Budapest Retina Associates

    Budapest, 1133

  • Semmelweis University, Dept of Ophthalmology

    Budapest, H-1085

  • Debrecen University Clinical Center, Dept of Ophthalmology

    Debrecen, H-4032

  • Szabolcs-Szatmar-Bereg County Hospital and University Teaching Hospital

    Nyíregyháza, 4400

  • Ganglion Medical Center

    Pécs, H-7621

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, H-6720

Other trials in Hungary

Canada7 sites

  • Calgary Retina Consultants

    Calgary, Alberta, T2H 0C8

  • St.Joseph's Health Care London

    London, Ontario, N6A4V2

  • Canadian Centre for Advanced Eye Therapeutics Inc.

    Mississauga, Ontario, L4W 1W9

  • University of Ottawa Eye Institute

    Ottawa, Ontario, K1H8L6

  • Retina Centre of Ottawa

    Ottawa, K2B 7E9

  • University Health Network

    Toronto, Ontario, M5T 2S8

  • UBC/VGH Eye Care Center

    Vancouver, British Columbia, V5Z3N9

Other trials in Canada

Austria4 sites

  • Medizinische Universitaet Graz - Augenklinik

    Graz, 8036

  • Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Augenheilkunde und Optometrie

    Innsbruck, 6020

  • Medical University of Vienna

    Vienna, 1090

  • Hanush Hospital

    Vienna, 1140

Other trials in Austria

Poland4 sites

  • Klinika Okulistyczna OFT ALMIKA Sp. z o. o.

    Bydgoszcz, 85-631

  • Medical Center Julianów

    Lodz, 91-485

  • Caminomed

    Tarnowskie Góry, 42-600

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

    Wroclaw, 50-556

Other trials in Poland

Australia3 sites

  • Royal Victorian Eye & Ear Hospital

    East Melbourne, 3002

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales, 2000

Other trials in Australia

Brazil3 sites

  • Centro de Ensino e Pesquisa do Instituto da Visao (CEPIV)

    Belo Horizonte, 30330

  • IPEPO - Instituto da visão

    São Paulo, 04038-032

  • Hospital Sao Paulo - UNIFESP

    Vila Clementino, 04023-062

Other trials in Brazil

Colombia2 sites

  • Fundacion OJlalmologica Nacional - FUNDONAL

    Bogotá, 110311

  • Clinica De Oftalmologia Sandiego

    Medellín, Antioquia, 050016

Other trials in Colombia

Estonia2 sites

  • Dr Kai Noor Silmakabinet

    Tallinn, 11412

  • Tartu University Hospital

    Tartu, 50406

Other trials in Estonia

Belgium1 site

  • CHU Brugmann

    Brussels

Other trials in Belgium

Croatia1 site

  • Clinical hospital Center Osijek

    Osijek, 31000

Other trials in Croatia

Czechia1 site

  • Axon Clinical s.r.o.

    Prague, Smichov, 150 00

Other trials in Czechia

Latvia1 site

  • Pauls Stradinis Clinical University Hospital

    Riga, LV-1002

Other trials in Latvia

United Kingdom1 site

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU3 2JZ

Other trials in United Kingdom

About this study

Official title: 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)

Read the 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

Being tested
Avacincaptad Pegol, Sham
Keywords
Geographic Atrophy (GA), Age-related Macular Degeneration, AMD, Complement C5 inhibitor, avacincaptad pegol, IZERVAY
Medical subject headings
Geographic Atrophy, Macular Degeneration

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

    Avacincaptad Pegol Intravitreal Injection

  • ShamDrug

    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)

Study groups in NCT04435366
Study groupRoleWhat they receive
Avacincaptad PegolExperimentalParticipants 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).
Receives: Drug: Avacincaptad Pegol
ShamSham comparatorParticipants 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).
Receives: Drug: Sham
Avacincaptad pegol and ShamExperimentalParticipants 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.
Receives: Drug: Avacincaptad Pegol

What is being measured

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

  1. 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

    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.

    Measured: Baseline to month 12

  2. 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

    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.

    Measured: Baseline to month 24

Secondary outcomes (6)

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months

    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.

    Measured: Baseline and month 24

  2. Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months

    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.

    Measured: Baseline and month 24

  3. Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months

    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.

    Measured: Baseline, months 6, 12, and 18

  4. Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months

    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.

    Measured: Baseline and month 24

  5. Number of Participants With Categorical One-level Loss in VFQ-25 Subscale

    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).

    Measured: Baseline up to month 24

  6. Time to Persistent Vision Loss

    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.

    Measured: Baseline up to month 24

Timeline

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

  1. First posted17 Jun 2020
  2. Study start22 Jun 2020
  3. Primary completion25 Jul 2022
  4. Study completion22 Aug 2023

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
448 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04435366
Sponsor's protocol ID
ISEE2008
Status last verified
Oct 2025
First submitted
12 May 2020
Last updated
21 Oct 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

  • Khanani AM, Danzig CJ, Heier JS, Jaffe GJ, Kaiser PK, Lally DR, Patel SS, Vajzovic L, Weng CY, Patel H, Clark J, Desai D, Luo D, Henry E, Holz FG; GATHER2 Trial Investigators. Avacincaptad Pegol for Geographic Atrophy Secondary to Age-Related Macular Degeneration: Two-Year Efficacy and Safety Results from the GATHER2 Phase 3 Trial. Ophthalmology. 2026 Apr;133(4):451-465. doi: 10.1016/j.ophtha.2025.12.011. Epub 2025 Dec 15.

    PubMed 41407269

  • Khanani AM, Patel SS, Staurenghi G, Tadayoni R, Danzig CJ, Eichenbaum DA, Hsu J, Wykoff CC, Heier JS, Lally DR, Mones J, Nielsen JS, Sheth VS, Kaiser PK, Clark J, Zhu L, Patel H, Tang J, Desai D, Jaffe GJ; GATHER2 trial investigators. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1449-1458. doi: 10.1016/S0140-6736(23)01583-0. Epub 2023 Sep 8.

    PubMed 37696275

  • 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 3 study testing Avacincaptad Pegol in people with Geographic Atrophy and Macular Degeneration, run by IVERIC bio, Inc. at 205 sites in 20 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 6 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 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in United States, Germany, Italy, France, Spain and 15 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 phase mean?

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 28 Dec 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?

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). The study lists 2 primary outcomes in all. 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 NCT04435366, 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 21 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in