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

Neovascular Age-related Macular Degeneration Clinical Trial

— AVONELLE-X  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04777201
• Other study ID #: GR42691
• Secondary ID: 2020-004523-16
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 19, 2021
• Est. completion date: August 9, 2024

Study information

• Verified date: March 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1036
• Est. completion date: August 9, 2024
• Est. primary completion date: August 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria for the Main Study:

• 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.

Inclusion Criteria for the Substudy:

• 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

Exclusion Criteria for the Main Study:

• 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

Exclusion Criteria for the Substudy:

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:

• Prior and/or current administration of faricimab in the fellow (non-study) eye

• Prior administration of brolucizumab in the fellow (non-study) eye

Exclusion Criteria in Either Eye for the Substudy:

• 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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Faricimab
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.

Other:
• Sham Procedure
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.

Locations

Country	Name	City	State
Argentina	Fundacion Zambrano	Caba
Argentina	Centro Oftalmológico Dr. Charles S.A.	Capital Federal
Argentina	Oftalmos	Capital Federal
Argentina	Buenos Aires Mácula	Ciudad Autonoma Buenos Aires
Argentina	Oftar	Mendoza
Argentina	Grupo Laser Vision	Rosario
Argentina	Organizacion Medica de Investigacion	San Nicolás
Australia	Eyeclinic Albury Wodonga	Albury	New South Wales
Australia	Centre For Eye Research Australia	East Melbourne	Victoria
Australia	The Lions Eye Institute	Nedlands	Western Australia
Australia	Retina Specialists Victoria	Rowville	Victoria
Australia	Strathfield Retina Clinic	Strathfield	New South Wales
Australia	Sydney Eye Hospital	Sydney	New South Wales
Australia	Sydney Retina Clinic and Day Surgery	Sydney	New South Wales
Australia	Sydney West Retina	Westmead	New South Wales
Austria	LKH-Univ.Klinikum Graz; Universitäts-Augenklinik	Graz
Austria	Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie	Wien
Brazil	Hospital de Olhos de Aparecida - HOA	Aparecida de Goiania	GO
Brazil	Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia	Sao Paulo	SP
Bulgaria	Pentagram Eye Hospital (Medical Center "Pentagram")	Sofia
Bulgaria	Specialized Hospital for Active Treatment of Eye Diseases Zora	Sofia
Canada	Institut De L'Oeil Des Laurentides	Boisbriand	Quebec
Canada	Calgary Retina Consultants	Calgary	Alberta
Canada	Ivey Eye Institute	London	Ontario
Canada	The Retina Centre of Ottawa	Ottawa	Ontario
Canada	Michel Giunta Clinique Medical	Sherbrooke	Quebec
Canada	Toronto Retina Institute	Toronto	Ontario
Canada	University of British Columbia - Vancouver Coastal Health Authority	Vancouver	British Columbia
Denmark	Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning	Glostrup
Denmark	Sjællands Universitetshospital, Roskilde; Øjenafdelingen	Roskilde
France	Chi De Creteil; Ophtalmologie	Creteil
France	Pole Vision Val d'Ouest; Ophtalmologie	Ecully
France	Hopital de la croix rousse; Ophtalmologie	Lyon cedex
France	Centre Paradis Monticelli; Ophtalmologie	Marseille
France	CHU Nantes - Hôtel Dieu; Ophthalmology	Nantes
France	Hopital Lariboisiere; Ophtalmologie	Paris
Germany	Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde	Düsseldorf
Germany	Universitätsklinikum Freiburg, Klinik für Augenheilkunde	Freiburg
Germany	Universitätsklinik Heidelberg; Augenklinik	Heidelberg
Germany	Universitätsklinikum Köln; Augenklinik	Köln
Germany	Augenabteilung am St. Franziskus-Hospital	Münster
Germany	Universitätsklinikum Münster; Augenheilkunde	Münster
Hong Kong	Queen Mary Hospital; Department of Ophthalmology	Hong Kong
Hong Kong	Hong Kong Eye Hospital; CUHK Eye Centre	Mongkok
Hungary	Bajcsy-Zsilinszky Hospital	Budapest
Hungary	Budapest Retina Associates Kft.	Budapest
Hungary	Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Szemeszet	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika	Debrecen
Hungary	Ganglion Medial Center	Pécs
Hungary	Szegedi Tudományegyetem ÁOK; Department of Ophtalmology	Szeged
Hungary	Zala Megyei Kórház; SZEMESZET	Zalaegerszeg
Israel	Rambam Medical Center; Opthalmology	Haifa
Israel	Hadassah MC; Ophtalmology	Jerusalem
Israel	Rabin MC; Ophtalmology	Petach Tikva
Israel	Kaplan Medical Center; Ophtalmology	Rehovot
Israel	Tel Aviv Sourasky MC; Ophtalmology	Tel Aviv
Italy	ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)	Milano	Lombardia
Italy	Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica	Milano	Lombardia
Italy	Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica	Perugia	Umbria
Italy	Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria	Pisa	Toscana
Italy	Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico	Roma	Lazio
Japan	Aichi Medical University Hospital	Aichi
Japan	Daiyukai Daiichi Hospital	Aichi
Japan	Nagoya City University Hospital	Aichi
Japan	Nagoya University Hospital	Aichi
Japan	Chiba University Hospital	Chiba
Japan	Toho University Sakura Medical Center	Chiba
Japan	Hayashi Eye Hospital	Fukuoka
Japan	Kurume University Hospital	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Asahikawa Medical University Hospital	Hokkaido
Japan	Sapporo City General Hospital	Hokkaido
Japan	Hyogo Medical University Hospital	Hyogo
Japan	Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)	Hyogo
Japan	Kozawa eye hospital and diabetes center	Ibaraki
Japan	Kagawa University Hospital	Kagawa
Japan	Kagoshima University Hospital	Kagoshima
Japan	Ideta Eye Hospital	Kumamoto
Japan	Kyoto University Hospital	Kyoto
Japan	Mie University Hospital	Mie
Japan	University of Miyazaki Hospital	Miyazaki
Japan	Iida Municipal Hospital	Nagano
Japan	Shinshu University Hospital	Nagano
Japan	Japanese Red Cross Nagasaki Genbaku Hospital	Nagasaki
Japan	Nara Medical University Hospital	Nara
Japan	University of the Ryukyus Hospital	Okinawa
Japan	Kansai Medical University Hospital	Osaka
Japan	Kansai Medical University Medical Center	Osaka
Japan	Kitano Hospital	Osaka
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	National Defense Medical College Hospital	Saitama
Japan	Shiga University Of Medical Science Hospital	Shiga
Japan	Kyorin University Hospital	Tokyo
Japan	Nihon University Hospital	Tokyo
Japan	Tokyo Medical University Hachioji Medical Center	Tokyo
Japan	Tokyo Women's Medical University Hospital	Tokyo
Japan	Yamaguchi University Hospital	Yamaguchi
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Nune Eye Hospital; Ophthalmology	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Mexico	Centro Oftalmológico Mira, S.C	Del. Cuauhtemoc	Mexico CITY (federal District)
Mexico	Macula Retina Consultores	Mexico, D.F.	Mexico CITY (federal District)
Mexico	Montemayor & Asociados (Oftalmologos)	Monterrey Nuevo LEON	Nuevo LEON
Netherlands	Het Oogziekenhuis Rotterdam	Rotterdam
Poland	Szpital sw. Lukasza	Bielsko-Biala
Poland	OFTALMIKA Sp. z o.o	Bydgoszcz
Poland	Specjalistyczny O?rodek Okulistyczny Oculomedica	Bydgoszcz
Poland	Szpital Specjalistyczny nr 1; Oddzial Okulistyki	Bytom
Poland	Dobry Wzrok Sp Z O O	Gda?sk
Poland	Optimum Profesorskie Centrum Okulistyki	Gda?sk
Poland	Gabinet Okulistyczny Prof Edward Wylegala	Katowice
Poland	SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej	Krakow
Poland	Centrum Medyczne Dietla 19 Sp. Z O.O.	Kraków
Poland	Caminomed	Tarnowskie Góry
Poland	SPEKTRUM Osrodek Okulistyki Klinicznej	Wroclaw
Portugal	Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia	Coimbra
Portugal	Hospital de Sao Joao; Servico de Oftalmologia	Porto
Russian Federation	Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch	Cheboksary	Marij EL
Russian Federation	Clinics of Eye Diseases, LLC	Kazan	Tatarstan
Russian Federation	FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences	Moscow	Moskovskaja Oblast
Russian Federation	?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch	Novosibirsk
Russian Federation	1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology	Sankt-peterburg	Sankt Petersburg
Russian Federation	Medical Military Academy n.a S.M.Kirov	St.Petersburg	Sankt Petersburg
Singapore	Singapore Eye Research Institute	Singapore
Spain	Hospital Clinic de Barcelona; Consultas Externas Oftalmologia	Barcelona
Spain	Hospital dos de maig; servicio de oftalmologia	Barcelona
Spain	Institut de la Macula i la retina	Barcelona
Spain	Oftalvist Valencia	Burjassot	Valencia
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Clinica Baviera; Servicio Oftalmologia	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia	Oviedo	Asturias
Spain	Clinica Universitaria de Navarra; Servicio de Oftalmologia	Pamplona	Navarra
Spain	Hospital General de Catalunya	San Cugat Del Valles	Barcelona
Spain	Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia	Santiago de Compostela	LA Coruña
Spain	Hospital Universitario Rio Hortega; Servicio de Oftalmologia	Valladolid
Spain	Hospital Universitario Miguel Servet; Servicio de Oftalmologia	Zaragoza
Switzerland	Vista Klinik Ophthalmologische Klinik	Binningen
Taiwan	Changhua Christian Hospital; Department of Ophthalmology	Changhua
Taiwan	Taipei Veterans General Hospital; Ophthalmology	Taipei
Taiwan	Chang Gung Medical Foundation - Linkou; Ophthalmology	Taoyuan
Turkey	Ankara Baskent University Medical Faculty; Department of Ophthalmology	Ankara
Turkey	Ankara University Medical Faculty; Department of Ophthalmology	Ankara
Turkey	Gazi University Faculty of Medicine; Department Of Ophthalmology	Ankara
Turkey	Hacettepe University Medical Faculty; Department of Ophthalmology	Ankara
Turkey	Ege University Medical Faculty; Department of Ophthalmology	Izmir
Turkey	Kocaeli University Medical Faculty	Kocaeli
Turkey	Selcuk University Faculty of Medicine; Department Of Ophthalmology	Konya
United Kingdom	Opthalmology Research Office	Bradford
United Kingdom	Bristol Eye Hospital;Retinal Treatment and Research Unit	Bristol
United Kingdom	University Hospital of Wales	Cardiff
United Kingdom	Frimley Park Hospital	Frimley
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust	Gloucestershire
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	St James University Hospital	Leeds
United Kingdom	Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre	Liverpool
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust	London
United Kingdom	Manchester Royal Eye Hospital	Manchester
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit	Southampton
United Kingdom	New Cross Hospital	Wolverhampton
United Kingdom	The York Hospital	York
United States	Retina Consultants of Hawaii	'Aiea	Hawaii
United States	Retina Res Institute of Texas	Abilene	Texas
United States	Western Carolina Retinal Associate PA	Asheville	North Carolina
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Clinical Research LLC	Austin	Texas
United States	Austin Retina Associates	Austin	Texas
United States	Johns Hopkins Med; Wilmer Eye Inst	Baltimore	Maryland
United States	The Retina Care Center	Baltimore	Maryland
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Tufts Medical Center; Ophthalmology	Boston	Massachusetts
United States	Retinal Diagnostic Center	Campbell	California
United States	Char Eye Ear &Throat Assoc	Charlotte	North Carolina
United States	Southeastern Retina Associates Chattanooga	Chattanooga	Tennessee
United States	Midwest Vision Research Foundation	Chesterfield	Missouri
United States	Retina Group of Washington	Chevy Chase	Maryland
United States	Northwestern Medical Group/Northwestern University	Chicago	Illinois
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Retina Assoc of Cleveland Inc	Cleveland	Ohio
United States	Retina Consultants of Southern	Colorado Springs	Colorado
United States	The Ohio State University Havener Eye Institute	Columbus	Ohio
United States	Texas Retina Associates	Dallas	Texas
United States	Rand Eye	Deerfield Beach	Florida
United States	Midwest Retina	Dublin	Ohio
United States	VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota	Edina	Minnesota
United States	NJ Retina	Edison	New Jersey
United States	The Retina Partners	Encino	California
United States	Retina Associates of St. Louis	Florissant	Missouri
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	Charles Retina Institute	Germantown	Tennessee
United States	Associated Retinal Consultants	Grand Rapids	Michigan
United States	Cumberland Valley Retina PC	Hagerstown	Maryland
United States	Valley Retina Institute P.A.	Harlingen	Texas
United States	Long Is. Vitreoretinal Consult	Hauppauge	New York
United States	Graystone Eye	Hickory	North Carolina
United States	Raj K. Maturi, MD PC	Indianapolis	Indiana
United States	Charleston Neuroscience Inst	Ladson	South Carolina
United States	Colorado Retina Associates, PC	Lakewood	Colorado
United States	Retina Associates	Lenexa	Kansas
United States	Retina Vit Surgeons/Central NY	Liverpool	New York
United States	South Coast Retina Center	Los Angeles	California
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Georgia Retina PC	Marietta	Georgia
United States	Florida Eye Associates	Melbourne	Florida
United States	Barnet Dulaney Perkins Eye Center	Mesa	Arizona
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Tennessee Retina PC.	Nashville	Tennessee
United States	Wagner Kapoor Institute	Norfolk	Virginia
United States	University Retina and Macula Associates, PC	Oak Forest	Illinois
United States	Ophthalmic Cons of Long Island	Oceanside	New York
United States	Retina Care Specialists	Palm Beach Gardens	Florida
United States	Southern CA Desert Retina Cons	Palm Desert	California
United States	California Eye Specialists Medical group Inc.	Pasadena	California
United States	Retina Specialty Institute	Pensacola	Florida
United States	Mid Atlantic Retina - Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Arizona Retina and Vitreous Consultants	Phoenix	Arizona
United States	Associated Retina Consultants	Phoenix	Arizona
United States	Fort Lauderdale Eye Institute	Plantation	Florida
United States	Maine Eye Center	Portland	Maine
United States	Retina Northwest	Portland	Oregon
United States	Retina Consultants, San Diego	Poway	California
United States	Black Hills Eye Institute	Rapid City	South Dakota
United States	Retina Consultants of Southern California	Redlands	California
United States	Sierra Eye Associates	Reno	Nevada
United States	Retina Assoc of Western NY	Rochester	New York
United States	Retinal Consultants Med Group	Sacramento	California
United States	University of California, Davis, Eye Center	Sacramento	California
United States	Retina Vitreous Assoc of FL	Saint Petersburg	Florida
United States	Retina Associates of Utah, PLLC	Salt Lake City	Utah
United States	Rocky Mountain Retina	Salt Lake City	Utah
United States	Orange County Retina Med Group	Santa Ana	California
United States	California Retina Consultants	Santa Barbara	California
United States	Island Retina	Shirley	New York
United States	Retina Center Northwest	Silverdale	Washington
United States	The Retina Consultants	Slingerlands	New York
United States	Retina Center of Texas	Southlake	Texas
United States	Prairie Retina Center	Springfield	Illinois
United States	Southern Vitreoretinal Assoc	Tallahassee	Florida
United States	Retina Associates of Florida, LLC	Tampa	Florida
United States	Retina Associates of NJ	Teaneck	New Jersey
United States	Retina Consultants of Houston	The Woodlands	Texas
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	Retina Specialists	Towson	Maryland
United States	Retina Associates Southwest PC	Tucson	Arizona
United States	Retina Group of New England	Waterford	Connecticut
United States	Palmetto Retina Center	West Columbia	South Carolina
United States	Wolfe Eye Clinic	West Des Moines	Iowa
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Bulgaria,  Canada,  Denmark,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Portugal,  Russian Federation,  Singapore,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main Study: Incidence and Severity of Ocular Adverse Events		Up to 2 years
Primary	Main Study: Incidence and Severity of Systemic (Non-Ocular) Adverse Events		Up to 2 years
Primary	Main Study: Number of Participants with Presence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study		From Baseline up to 2 years
Primary	Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With the Fellow Eye	1 Year is defined as the earliest substudy visit closest to Week 52 occurring between Week 48 and Week 64.	Baseline and 1 year
Secondary	Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye	Week 24 is defined as the earliest substudy visit closest to Week 24 occurring between Week 20 and Week 28.	Baseline and Week 24