Clinical trial NCT04740931: A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Official title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Edema
Central Retinal Vein Occlusion
Hemiretinal Vein Occlusion
Keywords: CRVO
HRVO
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Chugai Pharmaceutical
First posted: 2021-02-05
Enrollment: 729
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in patients with macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO).


Eligibility criteria: Inclusion Criteria:

* Foveal center-involved macular edema due to central retinal vein occlusion (CRVO) or hemiretinal vein occlusion (HRVO), diagnosed no longer than 4 months prior to the screening visit
* Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent)
* Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
* For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment

Exclusion Criteria:

* Any major illness or major surgical procedure within 1 month before screening
* Uncontrolled blood pressure
* Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
* Pregnant or breastfeeding, or intending to become pregnant during the study

Ocular Exclusion Criteria for Study Eye:

* History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
* Macular laser (focal/grid) in the study eye at any time prior to Day 1
* Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
* Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
* Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheathotomy
* Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)

Ocular Exclusion Criteria for Both Eyes:

* Prior IVT administration of faricimab in either eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1

Primary outcomes:
measure: Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24
timeFrame: From Baseline through Week 24
Secondary outcomes:
measure: Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24
timeFrame: From Baseline through Week 24
measure: Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24
timeFrame: Baseline and Week 24
measure: Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 24, 48, and 72
measure: Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72
timeFrame: Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
measure: Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
timeFrame: Week 68
measure: Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72
timeFrame: From Week 24 to Week 72
measure: Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale
timeFrame: Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
measure: Incidence of Ocular Adverse Events in the Fellow Eye
timeFrame: Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
measure: Incidence of Non-Ocular Adverse Events
timeFrame: Part 1: From first dose up to Week 24; Part 2: from Week 24 through Week 72
measure: Plasma Concentration of Faricimab Over Time
timeFrame: Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72
measure: Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and Post-Baseline During the Study
timeFrame: Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Barnet Dulaney Perkins Eye Center
state: Arizona
city: Phoenix
country: United States
facility: Retinal Research Institute, LLC
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: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Oakland
country: United States
facility: East Bay Retina Consultants
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: San Francisco
country: United States
facility: West Coast Retina Medical Group
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado PC
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: Advanced Research
state: Florida
city: Deerfield Beach
country: United States
facility: Rand Eye
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
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: 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: Elmhurst
country: United States
facility: Retina Associated Ltd
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: Lenexa
country: United States
facility: Retina Associates
state: Kansas
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: Royal Oak
country: United States
facility: Assoc Retinal Consultants PC
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: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
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: Rochester
country: United States
facility: Retina Assoc of Western NY
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Portland
country: United States
facility: Retina Northwest
state: Oregon
city: Springfield
country: United States
facility: Cascade Medical Research Institute LLC
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina - Wills Eye Hospital
state: Pennsylvania
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
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: 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: Bellaire
country: United States
facility: Retina & Vitreous of Texas
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
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: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Eye Institute
state: West Virginia
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: Capital Federal
country: Argentina
facility: Hospital Italiano; Ophtalmology
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Buenos Aires Mácula
city: Mendoza
country: Argentina
facility: Oftar
city: Rosario
country: Argentina
facility: Centro Oftalmólogos Especialistas
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: Save Sight Institute
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
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: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Blumenau
country: Brazil
facility: Botelho Hospital da Visao
state: SC
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
state: SP
city: Sorocaba
country: Brazil
facility: Hosp de Olhos de Sorocaba
state: SP
city: Beijing
country: China
facility: Beijing Hospital of Ministry of Health
city: Changchun
country: China
facility: The Second Hospital of Jilin University
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Guangzhou City
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
city: Hangzhou City
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shenyang City
country: China
facility: He Eye Specialist Shenyang Hospital
city: Shenzhen City
country: China
facility: The University of Hong Kong-Shenzhen Hospital; Local Ethic Committee
city: Tianjin City
country: China
facility: Tianjin Eye Hospital
city: Tianjin City
country: China
facility: Tianjin Medical University Eye Hospital
city: Wenzhou City
country: China
facility: Eye Hospital, Wenzhou Medical University
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Zhengzhou
country: China
facility: Henan Provincial Eye Hosptial
city: Prague
country: Czechia
facility: General Teaching Hospital Prague; Ophthalmology clinic
city: Prague
country: Czechia
facility: AXON Clinical
city: Creteil
country: France
facility: Chi De Creteil; Ophtalmologie
city: Paris
country: France
facility: Hopital Lariboisiere; Ophtalmologie
city: Paris
country: France
facility: Centre Ophtalmologique; Imagerie et laser
city: St Cyr Sur Loire
country: France
facility: Centres Ophtalmologique St Exupéry; Ophtalmologie
city: Düsseldorf-Oberkassel
country: Germany
facility: Internationale Innovative Ophthalmochirurgie GbR; c/o Makula-Netzhaut-Zentrum Breyer Kaymak Klabe
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
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: Bajcsy-Zsilinszky Hospital
city: Budapest
country: Hungary
facility: Budapest Retina Associates Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
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: Irccs Ospedale San Raffaele;U.O. Oculistica
state: Lombardia
city: Aichi
country: Japan
facility: Sugita Eye Hospital
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: 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: 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: Mie
country: Japan
facility: Mie University Hospital
city: Miyagi
country: Japan
facility: Fukushima Medical University Hospital
city: Nagano
country: Japan
facility: Shinshu University Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Osaka
country: Japan
facility: Kansai Medical University Medical Center
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
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: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital
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: Gliwice
country: Poland
facility: Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
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: Krosno
country: Poland
facility: MT Medic Krosno
city: Na??czów
country: Poland
facility: O?rodek Chirurgii Oka Prof. Zagórskiego Na??czów
city: Piaseczno
country: Poland
facility: Centrum Medyczne Pulawska SP. z o.o.
city: Rybnik
country: Poland
facility: Lens Clinic
city: Tarnowskie Góry
country: Poland
facility: Caminomed
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
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: Coimbra
country: Portugal
facility: Espaco Medico Coimbra
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria; Servico de Oftalmologia
city: UFA
country: Russian Federation
facility: Clinic Optimed
state: Baskortostan
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: Singapore
country: Singapore
facility: Singapore Eye Research Institute
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital; Ophthalmology Department
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: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra; Servicio de oftalmologia
state: Navarra
city: Barcelona
country: Spain
facility: Centro de Oftalmologia Barraquer; Servicio Oftalmologia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
city: Barcelona
country: Spain
facility: Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia
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: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
city: Birmingham
country: United Kingdom
facility: Birmingham Midland Eye Centre
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: 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: Central Middlesex Hospital
city: Maidstone
country: United Kingdom
facility: Maidstone and Tunbridge Wells NHS Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: