AzTrials
AzTrials

Neovascular Age-related Macular DegenerationPhase 3AVONELLE-XNCT04777201

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

A Phase 3 study testing Faricimab and Anti-VEGF Therapy in people with Neovascular Age-related Macular Degeneration, run by Hoffmann-La Roche at 251 sites in 27 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

This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Faricimab and Anti-VEGF Therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,036 participants
Where
251 sitesin 27 countries
Study dates
19 Apr 2021to 3 Sep 2024
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

  • Previous enrollment in and completion of Study GR40306 (NCT03823287) or Study GR40844 (NCT03823300), without study or study drug discontinuation
  • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs. Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 3 months after the final dose of faricimab. Women must refrain from donating eggs during the same period.
  • In addition to all inclusion criteria specified in the main Study GR42691, participants in the Substudy must meet the following criteria:
  • Sign an informed consent form for the Substudy
  • Must be able to participate for at least 48 weeks in the Substudy and have at least the first visit while enrolled in the main Study GR42691
  • A difference of <10% in corneal endothelial cell density at screening between the two eyes as measured by specular microscopy and determined by the independent reading center

Who cannot join

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab
  • Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
  • Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
  • History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study-related procedure preparations, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study
  • Requirement for continuous use of any medications or treatments indicated as prohibited therapy
  • In addition to the exclusion criteria specified in the main Study GR42691, patients will be excluded from this substudy if they meet any of the following exclusion criteria:
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  • Prior and/or current administration of faricimab in the fellow (non-study) eye
  • Prior administration of brolucizumab in the fellow (non-study) eye
  • Corneal endothelial cell density ≤1500 cells/mm2 in either eye at screening as determined by the independent corneal reading center
  • Fuchs endothelial corneal dystrophy Grade ≥2
  • Previous ocular trauma (blunt or penetrating) and/or corneal endothelial cell damage, including from blunt or surgical trauma (including complicated cataract surgery resulting in complicated lens placement such as anterior chamber intraocular lens, sulcus intraocular lens, aphakia, etc.)
  • Any ocular condition that precludes obtaining an analyzable specular microscopy image
  • Active or history of corneal edema
  • Any active or history of corneal dystrophies, excluding Fuchs endothelial corneal dystrophy Grade <2
  • Active or history of iridocorneal endothelial syndrome
  • Active or history of pseudoexfoliation syndrome
  • Active or history of herpetic keratitis or kerato-uveitis (including herpes simplex virus and herpes zoster virus)
  • Intraocular laser therapy including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening
  • Prior vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
  • Prior pars plana vitrectomy surgery
  • Previous intraocular device implantation excluding intraocular lenses
  • Cataract surgery within 6 months of screening or planned for during the study
  • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery. Other types of prior glaucoma surgery are allowed providing that the surgery occur more than 6 months before screening
  • Administration of topical Rho kinase inhibitors (e.g., Rhopressa eye drops) within 1 month prior to the screening visit
  • Contact lens wear in either eye within 2 months of screening
  • History of corneal transplantation, including partial-thickness corneal grafts (e.g., Descemet membrane endothelial keratoplasty, Descemet stripping endothelial keratoplasty)
  • Active or history of iridocorneal endothelial syndrome
  • Active or history of pseudoexfoliation syndrome

Trial locations and contacts

251 sites in 27 countries.

251 sites in 27 countries

United States85 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Retina Res Institute of Texas

    Abilene, Texas, 79606

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • Retina Specialists

    Baltimore, Maryland, 21204

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Johns Hopkins Med

    Baltimore, Maryland, 21287

  • Cincinnati Eye Institute

    Blue Ash, Ohio, 45242-5537

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Retinal Diagnostic Center

    Campbell, California, 95008

  • Char Eye Ear &Throat Assoc

    Charlotte, North Carolina, 28210

  • Southeastern Retina Associates Chattanooga

    Chattanooga, Tennessee, 37421

  • Mid Atlantic Retina - Wills Eye Hospital

    Cherry Hill, New Jersey, 08034

  • Midwest Vision Research Foundation

    Chesterfield, Missouri, 63017

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Northwestern Medical Group/Northwestern University

    Chicago, Illinois, 60611

  • Retina Assoc of Cleveland Inc

    Cleveland, Ohio, 44122

  • Retina Consultants of Southern

    Colorado Springs, Colorado, 80909

  • The Ohio State University Havener Eye Institute

    Columbus, Ohio, 43212

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Rand Eye

    Deerfield Beach, Florida, 33064

  • Midwest Retina

    Dublin, Ohio, 43016

  • VitreoRetinal Surgery, PLLC.

    Edina, Minnesota, 55435

  • NJ Retina

    Edison, New Jersey, 08820

  • The Retina Partners

    Encino, California, 91436

  • Retina Associates of St. Louis

    Florissant, Missouri, 63031

  • Retina Group of Florida

    Fort Lauderdale, Florida, 33308

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Long Is. Vitreoretinal Consult

    Great Neck, New York, 11021

  • Retina Consultants of Texas

    Houston, Texas, 77030

  • Raj K. Maturi, MD PC

    Indianapolis, Indiana, 46290

  • Charleston Neuroscience Inst

    Ladson, South Carolina, 29456

  • Colorado Retina Associates, PC

    Lakewood, Colorado, 80228

  • Retina Associates

    Lenexa, Kansas, 66215

  • South Coast Retina Center

    Los Angeles, California, 90033

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Georgia Retina PC

    Marietta, Georgia, 30060

  • Valley Retina Institute P.A.

    McAllen, Texas, 78503

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona, 85206

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Tennessee Retina PC.

    Nashville, Tennessee, 37203

  • Wagner Kapoor Institute

    Norfolk, Virginia, 23451

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • Ophthalmic Cons of Long Island

    Oceanside, New York, 11572

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • Southern CA Desert Retina Cons

    Palm Desert, California, 92211

  • California Eye Specialists Medical group Inc.

    Pasadena, California, 91107

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85016

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Maine Eye Center

    Portland, Maine, 04101

  • Retina Northwest

    Portland, Oregon, 97221

  • Retina Consultants, San Diego

    Poway, California, 92064

  • Black Hills Eye Institute

    Rapid City, South Dakota, 57701

  • Retina Consultants of Southern California

    Redlands, California, 92373

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Assoc of Western NY

    Rochester, New York, 14620

  • University of California, Davis, Eye Center

    Sacramento, California, 95817

  • Retinal Consultants Med Group

    Sacramento, California, 95825

  • Retina Associates of Utah, PLLC

    Salt Lake City, Utah, 84107

  • Rocky Mountain Retina

    Salt Lake City, Utah, 84107

  • Orange County Retina Med Group

    Santa Ana, California, 92705

  • California Retina Consultants

    Santa Barbara, California, 93103

  • Vitreoretinal Consultants of New York

    Shirley, New York, 11967

  • Pacific Northwest Retina

    Silverdale, Washington, 98383

  • The Retina Consultants

    Slingerlands, New York, 12159

  • Retina Center of Texas

    Southlake, Texas, 76092

  • Prairie Retina Center

    Springfield, Illinois, 62704

  • Retina Vitreous Assoc of FL

    St. Petersburg, Florida, 33711

  • Retina Vit Surgeons/Central NY

    Syracuse, New York, 13224

  • Southern Vitreoretinal Assoc

    Tallahassee, Florida, 32308

  • Retina Associates of Florida, LLC

    Tampa, Florida, 33609

  • Retina Associates of NJ

    Teaneck, New Jersey, 07666

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • Retina Associates Southwest PC

    Tucson, Arizona, 85704

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Graystone Eye

    Winston-Salem, North Carolina, 27104

Other trials in United States

Japan36 sites

  • Nagoya University Hospital

    Aichi, 466-8560

  • Nagoya City University Hospital

    Aichi, 467-8602

  • Aichi Medical University Hospital

    Aichi, 480-1195

  • Daiyukai Daiichi Hospital

    Aichi, 491-8551

  • Chiba University Hospital

    Chiba, 260-8677

  • Toho University Sakura Medical Center

    Chiba, 285-8741

  • Hayashi Eye Hospital

    Fukuoka, 812-0011

  • Kurume University Hospital

    Fukuoka, 830-0011

  • Sapporo City General Hospital

    Hokkaido, 060-8604

  • Asahikawa Medical University Hospital

    Hokkaido, 078-8510

  • Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

    Hyōgo, 660-8550

  • Hyogo Medical University Hospital

    Hyōgo, 663-8501

  • Kozawa eye hospital and diabetes center

    Ibaraki, 310-0845

  • Kagawa University Hospital

    Kagawa, 761-0793

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Ideta Eye Hospital

    Kumamoto, 860-0027

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Mie University Hospital

    Mie, 514-8507

  • Fukushima Medical University Hospital

    Miyagi, 960-1295

  • University of Miyazaki Hospital

    Miyazaki, 889-1692

  • Shinshu University Hospital

    Nagano, 390-8621

  • Iida Municipal Hospital

    Nagano, 395-8502

  • Japanese Red Cross Nagasaki Genbaku Hospital

    Nagasaki, 852-8511

  • Nara Medical University Hospital

    Nara, 634-8522

  • University of the Ryukyus Hospital

    Okinawa, 903-0125

  • Kitano Hospital

    Osaka, 530-8480

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • Kansai Medical University Medical Center

    Osaka, 570-8507

  • Kansai Medical University Hospital

    Osaka, 573-1191

  • National Defense Medical College Hospital

    Saitama, 359-8513

  • Shiga University Of Medical Science Hospital

    Shiga, 520-2192

  • Nihon University Hospital

    Tokyo, 101-8309

  • Tokyo Women's Medical University Hospital

    Tokyo, 162-8666

  • Kyorin University Hospital

    Tokyo, 181-8611

  • Tokyo Medical University Hachioji Medical Center

    Tokyo, 193-0998

  • Yamaguchi University Hospital

    Yamaguchi, 755-8505

Other trials in Japan

United Kingdom14 sites

  • Opthalmology Research Office

    Bradford, BD9 6RJ

  • Bristol Eye Hospital

    Bristol, BS1 2LX

  • University Hospital of Wales

    Cardiff, CF14 4XW

  • Frimley Park Hospital

    Frimley, GU16 7UJ

  • Gloucestershire Hospitals NHS Foundation Trust

    Gloucestershire, GL1 3NN

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • St James University Hospital

    Leeds, LS9 7TF

  • Royal Liverpool University Hospital

    Liverpool, L7 8XP

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD

  • Manchester Royal Eye Hospital

    Manchester, M13 9WL

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD

  • New Cross Hospital

    Wolverhampton, WV10 0QP

  • The York Hospital

    York, YO31 8HE

Other trials in United Kingdom

Spain13 sites

  • Institut de la Macula i la retina

    Barcelona, 08022

  • Hospital dos de maig

    Barcelona, 08025

  • Hospital Clinic de Barcelona

    Barcelona, 08028

  • Oftalvist Valencia

    Burjassot, Valencia, 46100

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Clinica Baviera

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Instituto Oftalmologico Fernandez Vega

    Oviedo, Principality of Asturias, 33012

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Hospital General de Catalunya

    San Cugat Del Valles, Barcelona, 08195

  • Instituto Oftalmologico Gomez Ulla

    Santiago de Compostela, LA Coruna, 15706

  • Hospital Universitario Rio Hortega

    Valladolid, 47012

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Poland11 sites

  • Szpital sw. Lukasza

    Bielsko-Biala, 43-309

  • OFTALMIKA Sp. z o.o

    Bydgoszcz, 85-631

  • Specjalistyczny O?rodek Okulistyczny Oculomedica

    Bydgoszcz, 85-870

  • Szpital Specjalistyczny nr 1

    Bytom, 41-902

  • Dobry Wzrok Sp Z O O

    Gda?sk, 80-402

  • Optimum Profesorskie Centrum Okulistyki

    Gda?sk, 80-809

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, 40-594

  • Centrum Medyczne Dietla 19 Sp. Z O.O.

    Krakow, 31-070

  • SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej

    Krakow, 31-501

  • Caminomed

    Tarnowskie Góry, 42-600

  • SPEKTRUM Osrodek Okulistyki Klinicznej

    Wroclaw, 53-334

Other trials in Poland

South Korea8 sites

  • Pusan National University Hospital

    Busan, 49241

  • Yeungnam University Medical Center

    Daegu, 42415

  • Seoul National University Bundang Hospital

    Seongnam-si, 13605

  • Samsung Medical Center

    Seoul, (0)6351

  • Kyung Hee University Hospital

    Seoul, 02447

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Nune Eye Hospital

    Seoul, 06192

Other trials in South Korea

Argentina7 sites

  • Organizacion Medica de Investigacion

    Buenos Aires, C1015ABO

  • Fundacion Zambrano

    CABA, 1023

  • Centro Oftalmologico Dr. Charles S.A.

    Capital Federal, C1116

  • Oftalmos

    Capital Federal, C1120AAN

  • Buenos Aires Mácula

    Ciudad Autonoma Buenos Aires, C1061AAE

  • Oftar

    Mendoza, M5500GGK

  • Grupo Laser Vision

    Rosario, S2000DLA

Other trials in Argentina

Australia7 sites

  • Eyeclinic Albury Wodonga

    Albury, New South Wales, 2640

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002

  • The Lions Eye Institute

    Nedlands, Western Australia, 6009

  • Retina Specialists Victoria

    Rowville, Victoria, 3178

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales, 2000

  • Sydney West Retina

    Westmead, New South Wales, 2145

Other trials in Australia

Canada7 sites

  • Institut De L'Oeil Des Laurentides

    Boisbriand, Quebec, J7H 0E8

  • Calgary Retina Consultants

    Calgary, Alberta, T2J 0C8

  • Ivey Eye Institute

    London, Ontario, N6A 4V2

  • Retina Institute of Ottawa

    Ottawa, Ontario, K2B 7E9

  • Michel Giunta Clinique Medical

    Sherbrooke, Quebec, J1G 2V4

  • Toronto Retina Institute

    Toronto, Ontario, M3C 0G9

  • University of British Columbia - Vancouver Coastal Health Authority

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Hungary7 sites

  • Eszak-Pesti Centrumkorhaz - Honvedkorhaz

    Budapest, 1068

  • Bajcsy-Zsilinszky Hospital

    Budapest, 1106

  • Budapest Retina Associates Kft.

    Budapest, 1133

  • Debreceni Egyetem Klinikai Kozpont

    Debrecem, 4032

  • Ganglion Medial Center

    Pécs, 7621

  • Szegedi Tudományegyetem ÁOK

    Szeged, 6720

  • Zala Megyei Kórház

    Zalaegerszeg, 8900

Other trials in Hungary

Turkey (Türkiye)7 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Ankara University Medical Faculty

    Ankara, 06340

  • Ankara Baskent University Medical Faculty

    Ankara, 06490

  • Gazi University Faculty of Medicine

    Ankara, 06560

  • Ege University Medical Faculty

    Izmir, 35100

  • Kocaeli University Medical Faculty

    Kocaeli, 41380

  • Selcuk University Faculty of Medicine

    Konya, 42130

Other trials in Turkey (Türkiye)

France6 sites

  • Chi De Creteil

    Créteil, 94010

  • Pole Vision Val d'Ouest

    Écully, 69130

  • Hopital de la croix rousse

    Lyon, 69317

  • Centre Paradis Monticelli

    Marseille, 13008

  • CHU Nantes - Hotel Dieu

    Nantes, 44093

  • Hopital Lariboisiere

    Paris, 75010

Other trials in France

Germany6 sites

  • Universitatsklinikum Koln

    Cologne, 50937

  • Universitätkslinikum Düsseldorf, Augenklinik

    Düsseldorf, 40225

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau, 79106

  • Universitätsklinik Heidelberg

    Heidelberg, 69120

  • Augenabteilung am St. Franziskus-Hospital

    Münster, 48145

  • Universitatsklinikum Munster

    Münster, 48149

Other trials in Germany

Russia6 sites

  • Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov

    Cheboksary, Mariy-El Republic, 428000

  • Clinics of Eye Diseases, LLC

    Kazan', Tatarstan Republic, 420066

  • FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences

    Moscow, Moscow Oblast, 119435

  • ?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

    Novosibirsk, 630096

  • Medical Military Academy n.a S.M.Kirov

    Saint Petersburg, Sankt-Peterburg, 124044

  • 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov

    Saint Petersburg, Sankt-Peterburg, 197022

Other trials in Russia

Israel5 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Hadassah MC

    Jerusalem, 9112001

  • Rabin MC

    Petah Tikva, 4941492

  • Kaplan Medical Center

    Rehovot, 7660101

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906

Other trials in Israel

Italy5 sites

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena

    Milan, Lombardy, 20100

  • Asst Fatebenefratelli Sacco

    Milan, Lombardy, 20157

  • Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia

    Perugia, Umbria, 06129

  • Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello

    Pisa, Tuscany, 56124

  • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

    Rome, Lazio, 00198

Other trials in Italy

Mexico3 sites

  • Centro Oftalmológico Mira, S.C

    Del. Cuauhtemoc, Mexico CITY (federal District), 06760

  • Macula Retina Consultores

    Mexico City, Mexico CITY (federal District), 01120

  • Montemayor & Asociados (Oftalmologos)

    Monterrey Nuevo LEON, Nuevo León, 64060

Other trials in Mexico

Taiwan3 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333

Other trials in Taiwan

Austria2 sites

  • LKH-Univ.Klinikum Graz

    Graz, 8036

  • Medizinische Universitat Wien

    Vienna, 1090

Other trials in Austria

Brazil2 sites

  • Hospital de Olhos de Aparecida - HOA

    Aparecida de Goiânia, Goiás, 74980-010

  • Universidade Federal de Sao Paulo - UNIFESPX

    São Paulo, São Paulo, 04023-062

Other trials in Brazil

Bulgaria2 sites

  • Pentagram Eye Hospital (Medical Center "Pentagram")

    Sofia, 1309

  • Specialized Hospital for Active Treatment of Eye Diseases Zora

    Sofia, 1784

Other trials in Bulgaria

Denmark2 sites

  • Rigshospitalet Glostrup

    Glostrup Municipality, 2600

  • Sjællands Universitetshospital, Roskilde

    Roskilde, 4000

Other trials in Denmark

Hong Kong2 sites

  • The University of Hong Kong

    Hong Kong

  • Hong Kong Eye Hospital

    Mong Kok

Other trials in Hong Kong

Portugal2 sites

  • Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia

    Coimbra, 3000-075

  • Hospital de Sao Joao

    Porto, 4200-319

Other trials in Portugal

Netherlands1 site

  • Het Oogziekenhuis Rotterdam

    Rotterdam, 3011 BH

Other trials in Netherlands

Singapore1 site

  • Singapore Eye Research Institute

    Singapore, 168751

Other trials in Singapore

Switzerland1 site

  • Vista Klinik Ophthalmologische Klinik

    Binningen, 4102

Other trials in Switzerland

About this study

Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (AVONELLE-X)

This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this main study will be enrolled upon completion of the end-of-study visit in the parent study.

Additionally, there is a substudy that is being conducted. The aim of this substudy is to evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA) post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy will serve as the controls.

Being tested
Faricimab, Sham Procedure, Anti-VEGF Therapy

What participants receive

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

  • FaricimabDrug

    Also called RO6867461, RG7716

    Faricimab 6 mg will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.

  • Sham ProcedureOther

    The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 12 weeks of this study in order to maintain the masking of the initial faricimab PTI.

  • Anti-VEGF TherapyDrug

    At the discretion of the principal investigator, participants were allowed to have their fellow (non-study) eye treated with the standard of care anti-VEGF therapy (if needed) according to region-specific anti-VEGF prescribing information for the recommended dose and frequency of treatment.

Study groups in NCT04777201
Study groupRoleWhat they receive
Main Study: Faricimab PTIExperimentalNot described
Receives: Drug: Faricimab; Other: Sham Procedure; Drug: Anti-VEGF Therapy
Substudy: Faricimab PTIExperimentalNot described
Receives: Drug: Faricimab; Drug: Anti-VEGF Therapy

What is being measured

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

  1. Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale

    This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

    Measured: From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)

  2. Incidence of Ocular Adverse Events in the Fellow Eye

    This is an analysis of participants with at least one ocular adverse event (AE) that occurred in the study eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity, and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

    Measured: From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)

  3. Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale

    This is an analysis of participants with at least one non-ocular (systemic) adverse event (AE). Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of the seriousness, severity (e.g., mild, moderate, or severe intensity), and causality for each AE. AEs of special interest (AESI) included the following: Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, are associated with severe intraocular inflammation (IOI), or require surgical or medical intervention to prevent permanent loss of sight; suspected transmission of an infectious agent by the study drug; and, cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

    Measured: From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)

  4. Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With the Fellow Eye

    Specular microscopy was performed for both eyes prior to application of any topical ophthalmic anesthetic, tonometry, or any other study treatment on the same day for the evaluation of corneal endothelial cell (CEC) density. The 1-year timepoint was defined as the earliest substudy visit closest to Week 52 occurring between Week 48 and Week 64. Data (from both study eye and fellow eye) collected after the fellow eye's use of prohibited therapies-such as faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation-were excluded from the corneal endothelial cell analysis.

    Measured: Baseline and 1 year

Secondary outcomes (1)

  1. Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye

    Specular microscopy was performed for both eyes prior to application of any topical ophthalmic anesthetic, tonometry, or any other study treatment on the same day for the evaluation of corneal endothelial cell (CEC) density. The Week 24 timepoint was defined as the earliest substudy visit closest to Week 24 occurring between Week 20 and Week 28. Data (from both study eye and fellow eye) collected after the fellow eye's use of prohibited therapies-such as faricimab, brolucizumab, bevacizumab, and Port Delivery System implantation-were excluded from the corneal endothelial cell analysis.

    Measured: Baseline and Week 24

Timeline

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

  1. First posted2 Mar 2021
  2. Study start19 Apr 2021
  3. Primary completion3 Sep 2024
  4. Study completion3 Sep 2024

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,036 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04777201
Sponsor's protocol ID
GR42691
Other IDs
2020-004523-16
Acronym
AVONELLE-X
Status last verified
Oct 2025
First submitted
26 Feb 2021
Last updated
24 Oct 2025
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Faricimab and Anti-VEGF Therapy in people with Neovascular Age-related Macular Degeneration, run by Hoffmann-La Roche at 251 sites in 27 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 6 inclusion and 28 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 24 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 251 sites in United States, Japan, United Kingdom, Spain, Poland and 22 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. 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 24 Oct 2025). 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?

Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale (time frame: From the date of first administration of faricimab through 28 days after the end of study (up to 2 years)). The study lists 4 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 NCT04777201.

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 24 Oct 2025.

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