Clinical trial NCT04777201: A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2021-03-02
Enrollment: 1036
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Main Study: Incidence and Severity of Ocular Adverse Events
timeFrame: Up to 2 years
measure: Main Study: Incidence and Severity of Systemic (Non-Ocular) Adverse Events
timeFrame: Up to 2 years
measure: Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at 1 Year in the Study Eye as Compared With the Fellow Eye
timeFrame: Baseline and 1 year
Secondary outcomes:
measure: Substudy: Percent Change in Corneal Endothelial Cell Density From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Retina and Vitreous Consultants
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Tucson
country: United States
facility: Retina Associates Southwest PC
state: Arizona
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Los Angeles
country: United States
facility: South Coast Retina Center
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Palm Desert
country: United States
facility: Southern CA Desert Retina Cons
state: California
city: Pasadena
country: United States
facility: California Eye Specialists Medical group Inc.
state: California
city: Poway
country: United States
facility: Retina Consultants, San Diego
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Sacramento
country: United States
facility: University of California, Davis, Eye Center
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Med Group
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Med Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern
state: Colorado
city: Lakewood
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Waterford
country: United States
facility: Retina Group of New England
state: Connecticut
city: Deerfield Beach
country: United States
facility: Rand Eye
state: Florida
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Palm Beach Gardens
country: United States
facility: Retina Care Specialists
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Plantation
country: United States
facility: Fort Lauderdale Eye Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Assoc of FL
state: Florida
city: Tallahassee
country: United States
facility: Southern Vitreoretinal Assoc
state: Florida
city: Tampa
country: United States
facility: Retina Associates of Florida, LLC
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Marietta
country: United States
facility: Georgia Retina PC
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii
state: Hawaii
city: Chicago
country: United States
facility: Northwestern Medical Group/Northwestern University
state: Illinois
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Springfield
country: United States
facility: Prairie Retina Center
state: Illinois
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD PC
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Lenexa
country: United States
facility: Retina Associates
state: Kansas
city: Portland
country: United States
facility: Maine Eye Center
state: Maine
city: Baltimore
country: United States
facility: The Retina Care Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Med; Wilmer Eye Inst
state: Maryland
city: Chevy Chase
country: United States
facility: Retina Group of Washington
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina PC
state: Maryland
city: Towson
country: United States
facility: Retina Specialists
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center; Ophthalmology
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Grand Rapids
country: United States
facility: Associated Retinal Consultants
state: Michigan
city: Edina
country: United States
facility: VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
state: Minnesota
city: Chesterfield
country: United States
facility: Midwest Vision Research Foundation
state: Missouri
city: Florissant
country: United States
facility: Retina Associates of St. Louis
state: Missouri
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Edison
country: United States
facility: NJ Retina
state: New Jersey
city: Teaneck
country: United States
facility: Retina Associates of NJ
state: New Jersey
city: Hauppauge
country: United States
facility: Long Is. Vitreoretinal Consult
state: New York
city: Liverpool
country: United States
facility: Retina Vit Surgeons/Central NY
state: New York
city: Oceanside
country: United States
facility: Ophthalmic Cons of Long Island
state: New York
city: Rochester
country: United States
facility: Retina Assoc of Western NY
state: New York
city: Shirley
country: United States
facility: Island Retina
state: New York
city: Slingerlands
country: United States
facility: The Retina Consultants
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associate PA
state: North Carolina
city: Charlotte
country: United States
facility: Char Eye Ear &Throat Assoc
state: North Carolina
city: Hickory
country: United States
facility: Graystone Eye
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Cleveland
country: United States
facility: Retina Assoc of Cleveland Inc
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Havener Eye Institute
state: Ohio
city: Dublin
country: United States
facility: Midwest Retina
state: Ohio
city: Portland
country: United States
facility: Retina Northwest
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina - Wills Eye Hospital
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Inst
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Eye Institute
state: South Dakota
city: Chattanooga
country: United States
facility: Southeastern Retina Associates Chattanooga
state: Tennessee
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina PC.
state: Tennessee
city: Abilene
country: United States
facility: Retina Res Institute of Texas
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research LLC
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Harlingen
country: United States
facility: Valley Retina Institute P.A.
state: Texas
city: Southlake
country: United States
facility: Retina Center of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah, PLLC
state: Utah
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina
state: Utah
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Norfolk
country: United States
facility: Wagner Kapoor Institute
state: Virginia
city: Silverdale
country: United States
facility: Retina Center Northwest
state: Washington
city: Caba
country: Argentina
facility: Fundacion Zambrano
city: Capital Federal
country: Argentina
facility: Centro Oftalmológico Dr. Charles S.A.
city: Capital Federal
country: Argentina
facility: Oftalmos
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Buenos Aires Mácula
city: Mendoza
country: Argentina
facility: Oftar
city: Rosario
country: Argentina
facility: Grupo Laser Vision
city: San Nicolás
country: Argentina
facility: Organizacion Medica de Investigacion
city: Albury
country: Australia
facility: Eyeclinic Albury Wodonga
state: New South Wales
city: Strathfield
country: Australia
facility: Strathfield Retina Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
state: New South Wales
city: Westmead
country: Australia
facility: Sydney West Retina
state: New South Wales
city: East Melbourne
country: Australia
facility: Centre For Eye Research Australia
state: Victoria
city: Rowville
country: Australia
facility: Retina Specialists Victoria
state: Victoria
city: Nedlands
country: Australia
facility: The Lions Eye Institute
state: Western Australia
city: Graz
country: Austria
facility: LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
city: Wien
country: Austria
facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
city: Aparecida de Goiania
country: Brazil
facility: Hospital de Olhos de Aparecida - HOA
state: GO
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
state: SP
city: Sofia
country: Bulgaria
facility: Pentagram Eye Hospital (Medical Center "Pentagram")
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Eye Diseases Zora
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia - Vancouver Coastal Health Authority
state: British Columbia
city: London
country: Canada
facility: Ivey Eye Institute
state: Ontario
city: Ottawa
country: Canada
facility: The Retina Centre of Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Toronto Retina Institute
state: Ontario
city: Boisbriand
country: Canada
facility: Institut De L'Oeil Des Laurentides
state: Quebec
city: Sherbrooke
country: Canada
facility: Michel Giunta Clinique Medical
state: Quebec
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen
city: Creteil
country: France
facility: Chi De Creteil; Ophtalmologie
city: Ecully
country: France
facility: Pole Vision Val d'Ouest; Ophtalmologie
city: Lyon cedex
country: France
facility: Hopital de la croix rousse; Ophtalmologie
city: Marseille
country: France
facility: Centre Paradis Monticelli; Ophtalmologie
city: Nantes
country: France
facility: CHU Nantes - Hôtel Dieu; Ophthalmology
city: Paris
country: France
facility: Hopital Lariboisiere; Ophtalmologie
city: Düsseldorf
country: Germany
facility: Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde
city: Heidelberg
country: Germany
facility: Universitätsklinik Heidelberg; Augenklinik
city: Köln
country: Germany
facility: Universitätsklinikum Köln; Augenklinik
city: Münster
country: Germany
facility: Augenabteilung am St. Franziskus-Hospital
city: Münster
country: Germany
facility: Universitätsklinikum Münster; Augenheilkunde
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital; Department of Ophthalmology
city: Mongkok
country: Hong Kong
facility: Hong Kong Eye Hospital; CUHK Eye Centre
city: Budapest
country: Hungary
facility: Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Szemeszet
city: Budapest
country: Hungary
facility: Bajcsy-Zsilinszky Hospital
city: Budapest
country: Hungary
facility: Budapest Retina Associates Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
city: Pécs
country: Hungary
facility: Ganglion Medial Center
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Kórház; SZEMESZET
city: Haifa
country: Israel
facility: Rambam Medical Center; Opthalmology
city: Jerusalem
country: Israel
facility: Hadassah MC; Ophtalmology
city: Petach Tikva
country: Israel
facility: Rabin MC; Ophtalmology
city: Rehovot
country: Israel
facility: Kaplan Medical Center; Ophtalmology
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky MC; Ophtalmology
city: Roma
country: Italy
facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
state: Lazio
city: Milano
country: Italy
facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
state: Lombardia
city: Milano
country: Italy
facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
state: Lombardia
city: Pisa
country: Italy
facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria
state: Toscana
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica
state: Umbria
city: Aichi
country: Japan
facility: Nagoya University Hospital
city: Aichi
country: Japan
facility: Nagoya City University Hospital
city: Aichi
country: Japan
facility: Aichi Medical University Hospital
city: Aichi
country: Japan
facility: Daiyukai Daiichi Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chiba
country: Japan
facility: Toho University Sakura Medical Center
city: Fukuoka
country: Japan
facility: Hayashi Eye Hospital
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Hokkaido
country: Japan
facility: Sapporo City General Hospital
city: Hokkaido
country: Japan
facility: Asahikawa Medical University Hospital
city: Hyogo
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Ibaraki
country: Japan
facility: Kozawa eye hospital and diabetes center
city: Kagawa
country: Japan
facility: Kagawa University Hospital
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kumamoto
country: Japan
facility: Ideta Eye Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Mie
country: Japan
facility: Mie University Hospital
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Nagano
country: Japan
facility: Shinshu University Hospital
city: Nagano
country: Japan
facility: Iida Municipal Hospital
city: Nagasaki
country: Japan
facility: Japanese Red Cross Nagasaki Genbaku Hospital
city: Nara
country: Japan
facility: Nara Medical University Hospital
city: Okinawa
country: Japan
facility: University of the Ryukyus Hospital
city: Osaka
country: Japan
facility: Kitano Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Osaka
country: Japan
facility: Kansai Medical University Medical Center
city: Osaka
country: Japan
facility: Kansai Medical University Hospital
city: Saitama
country: Japan
facility: National Defense Medical College Hospital
city: Shiga
country: Japan
facility: Shiga University Of Medical Science Hospital
city: Tokyo
country: Japan
facility: Nihon University Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
city: Yamaguchi
country: Japan
facility: Yamaguchi University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Nune Eye Hospital; Ophthalmology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Del. Cuauhtemoc
country: Mexico
facility: Centro Oftalmológico Mira, S.C
state: Mexico CITY (federal District)
city: Mexico, D.F.
country: Mexico
facility: Macula Retina Consultores
state: Mexico CITY (federal District)
city: Monterrey Nuevo LEON
country: Mexico
facility: Montemayor & Asociados (Oftalmologos)
state: Nuevo LEON
city: Rotterdam
country: Netherlands
facility: Het Oogziekenhuis Rotterdam
city: Bielsko-Biala
country: Poland
facility: Szpital sw. Lukasza
city: Bydgoszcz
country: Poland
facility: OFTALMIKA Sp. z o.o
city: Bydgoszcz
country: Poland
facility: Specjalistyczny O?rodek Okulistyczny Oculomedica
city: Bytom
country: Poland
facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki
city: Gda?sk
country: Poland
facility: Dobry Wzrok Sp Z O O
city: Gda?sk
country: Poland
facility: Optimum Profesorskie Centrum Okulistyki
city: Katowice
country: Poland
facility: Gabinet Okulistyczny Prof Edward Wylegala
city: Krakow
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
city: Kraków
country: Poland
facility: Centrum Medyczne Dietla 19 Sp. Z O.O.
city: Tarnowskie Góry
country: Poland
facility: Caminomed
city: Wroclaw
country: Poland
facility: SPEKTRUM Osrodek Okulistyki Klinicznej
city: Coimbra
country: Portugal
facility: Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia
city: Porto
country: Portugal
facility: Hospital de Sao Joao; Servico de Oftalmologia
city: Cheboksary
country: Russian Federation
facility: Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch
state: Marij EL
city: Moscow
country: Russian Federation
facility: FSBI ?Scientific Research Institute of Eye Diseases? of Russian Academy of medical Sciences
state: Moskovskaja Oblast
city: Sankt-peterburg
country: Russian Federation
facility: 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology
state: Sankt Petersburg
city: St.Petersburg
country: Russian Federation
facility: Medical Military Academy n.a S.M.Kirov
state: Sankt Petersburg
city: Kazan
country: Russian Federation
facility: Clinics of Eye Diseases, LLC
state: Tatarstan
city: Novosibirsk
country: Russian Federation
facility: ?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
city: Oviedo
country: Spain
facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: San Cugat Del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia
state: LA Coruña
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia
state: Navarra
city: Burjassot
country: Spain
facility: Oftalvist Valencia
state: Valencia
city: Barcelona
country: Spain
facility: Institut de la Macula i la retina
city: Barcelona
country: Spain
facility: Hospital dos de maig; servicio de oftalmologia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
city: Madrid
country: Spain
facility: Clinica Baviera; Servicio Oftalmologia
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio de Oftalmologia
city: Binningen
country: Switzerland
facility: Vista Klinik Ophthalmologische Klinik
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital; Department of Ophthalmology
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital; Ophthalmology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Ophthalmology
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty; Department of Ophthalmology
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty; Department of Ophthalmology
city: Ankara
country: Turkey
facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology
city: Ankara
country: Turkey
facility: Gazi University Faculty of Medicine; Department Of Ophthalmology
city: Izmir
country: Turkey
facility: Ege University Medical Faculty; Department of Ophthalmology
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Konya
country: Turkey
facility: Selcuk University Faculty of Medicine; Department Of Ophthalmology
city: Bradford
country: United Kingdom
facility: Opthalmology Research Office
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital;Retinal Treatment and Research Unit
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Frimley
country: United Kingdom
facility: Frimley Park Hospital
city: Gloucestershire
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester Royal Eye Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: York
country: United Kingdom
facility: The York Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: