Rhone-X: A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04432831
Collaborator
(none)
1,479
318
1
36.4
4.7
0.1

Study Details

Study Description

Brief Summary

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1479 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
The first 16 weeks of this study will be a masked period (to transition from the multi-arm parent studies) during which participants may receive either faricimab or sham injection. Participants and physicians will be masked only to the faricimab treatment interval. After the Week 16 treatment procedure, this study will follow an open-label design. The BCVA examiner will remain masked for the duration of this long-term extension study.
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema
Actual Study Start Date :
Aug 5, 2020
Anticipated Primary Completion Date :
Aug 18, 2023
Anticipated Study Completion Date :
Aug 18, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Faricimab PTI

Drug: Faricimab
Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.
Other Names:
  • RO6867461
  • RG7716
  • 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 16 weeks of this study in order to maintain the masking of the initial faricimab PTI.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and Severity of Ocular Adverse Events [Up to 2 years]

    2. Incidence and Severity of Systemic (Non-Ocular) Adverse Events [Up to 2 years]

    3. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Previous enrollment in and completion of Study GR40349 (NCT03622580) or GR40398 (NCT03622593), without study or study drug discontinuation

    • Ability to comply with the study protocol, in the investigator's judgment

    • For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment

    Exclusion Criteria:
    • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final intravitreal injection 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 treatment procedure, 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barnet Dulaney Perkins Eye Center Mesa Arizona United States 85206
    2 Retinal Research Institute, LLC Phoenix Arizona United States 85014
    3 Arizona Retina and Vitreous Consultants Phoenix Arizona United States 85021
    4 Retina Associates Southwest PC Tucson Arizona United States 85704
    5 California Retina Consultants Bakersfield California United States 93309
    6 Retina-Vitreous Associates Medical Group Beverly Hills California United States 90211
    7 Retinal Diagnostic Center Campbell California United States 95008
    8 The Retina Partners Encino California United States 91436
    9 Eye Medical Center Fresno California United States 93720
    10 Retina Consultants of Orange County Fullerton California United States 92835
    11 Southern California Permanente Medical Group Los Angeles California United States 90027
    12 Northern California Retina Vitreous Associates Mountain View California United States 94040
    13 East Bay Retina Consultants Oakland California United States 94609
    14 Southern CA Desert Retina Cons Palm Desert California United States 92211
    15 California Eye Specialists Medical group Inc. Pasadena California United States 91107
    16 Retina Consultants, San Diego Poway California United States 92064
    17 Retina Consultants of Southern California Redlands California United States 92373
    18 Retinal Consultants Med Group Sacramento California United States 95825
    19 West Coast Retina Medical Group San Francisco California United States 94109
    20 Orange County Retina Med Group Santa Ana California United States 92705
    21 California Retina Consultants Santa Barbara California United States 93103
    22 California Retina Consultants - Santa Maria Santa Maria California United States 93454
    23 Bay Area Retina Associates Walnut Creek California United States 94598
    24 University of Colorado; dept of ophthalmology Aurora Colorado United States 80045
    25 Retina Consultants of Southern Colorado Springs Colorado United States 80909
    26 Colorado Retina Associates, PC Lakewood Colorado United States 80228
    27 Retina Group of New England Waterford Connecticut United States 06385
    28 Rand Eye Deerfield Beach Florida United States 33064
    29 Retina Group of Florida Fort Lauderdale Florida United States 33308
    30 National Ophthalmic Research Institute Fort Myers Florida United States 33912
    31 Florida Eye Associates Melbourne Florida United States 32901
    32 Retina Care Specialists Palm Beach Gardens Florida United States 33410
    33 Retina Specialty Institute Pensacola Florida United States 32503
    34 Fort Lauderdale Eye Institute Plantation Florida United States 33324
    35 Retina Vitreous Assoc of FL Saint Petersburg Florida United States 33711
    36 Southern Vitreoretinal Assoc Tallahassee Florida United States 32308
    37 Retina Associates of Florida, LLC Tampa Florida United States 33609
    38 Southeast Retina Center Augusta Georgia United States 30909
    39 Georgia Retina PC Marietta Georgia United States 30060
    40 Retina Consultants of Hawaii 'Aiea Hawaii United States 96701
    41 University Retina and Macula Associates, PC Lemont Illinois United States 60439
    42 Prairie Eye & LASIK Center / Prairie Retina Center Springfield Illinois United States 62704
    43 Midwest Eye Institute Indianapolis Indiana United States 46290
    44 Wolfe Eye Clinic West Des Moines Iowa United States 50266
    45 Retina Associates Lenexa Kansas United States 66215
    46 Vitreo-Retinal Consultants Wichita Kansas United States 67214
    47 Retina Associates of Kentucky Lexington Kentucky United States 40509
    48 Maine Eye Center Portland Maine United States 04101
    49 The Retina Care Center Baltimore Maryland United States 21209
    50 Johns Hopkins Med; Wilmer Eye Inst Baltimore Maryland United States 21287
    51 Retina Group of Washington Chevy Chase Maryland United States 20815
    52 Cumberland Valley Retina PC Hagerstown Maryland United States 21740
    53 Retina Specialists Towson Maryland United States 21204
    54 Tufts Medical Center; Ophthalmology Boston Massachusetts United States 02111
    55 Ophthalmic Consultants of Boston Boston Massachusetts United States 02114
    56 Beetham Eye Institute, Joslin Diabetes Center Boston Massachusetts United States 02215
    57 Vitreo-Retinal Associates, PC Worcester Massachusetts United States 01605
    58 Associated Retinal Consultants Grand Rapids Michigan United States 49546
    59 Foundation for Vision Research Grand Rapids Michigan United States 49546
    60 Vitreo-Retinal Associates Grand Rapids Michigan United States 49546
    61 Assoc Retinal Consultants PC Royal Oak Michigan United States 48073
    62 Associated Retinal Consultants, P.C. Traverse City Michigan United States 49686
    63 Vitreoretinal Surgery Edina Minnesota United States 55435
    64 Midwest Vision Research Foundation Chesterfield Missouri United States 63017
    65 Sierra Eye Associates Reno Nevada United States 89502
    66 Mid Atlantic Retina - Wills Eye Hospital Cherry Hill New Jersey United States 08034
    67 NJRetina Edison New Jersey United States 08820
    68 Retinal & Ophthalmic Cons PC Northfield New Jersey United States 08225
    69 Retina Associates of NJ Teaneck New Jersey United States 07666
    70 University of New Mexico Albuquerque New Mexico United States 87131
    71 Capital Region Retina Albany New York United States 12206
    72 Long Is. Vitreoretinal Consult Great Neck New York United States 11021
    73 Retina Vit Surgeons/Central NY Liverpool New York United States 13088
    74 New York University New York New York United States 10017
    75 Ophthalmic Cons of Long Island Oceanside New York United States 11572
    76 Retina Associates of Western New York Rochester New York United States 14620
    77 Island Retina Shirley New York United States 11967
    78 The Retina Consultants Slingerlands New York United States 12159
    79 Western Carolina Retinal Associate PA Asheville North Carolina United States 28803
    80 Char Eye Ear &Throat Assoc Charlotte North Carolina United States 28210
    81 Graystone Eye Hickory North Carolina United States 28602
    82 Wake Forest Baptist Health Eye Centre Winston-Salem North Carolina United States 27157
    83 Cincinnati Eye Institute Cincinnati Ohio United States 45242
    84 Retina Assoc of Cleveland Inc Cleveland Ohio United States 44122
    85 Cleveland Clinic Foundation; Cole Eye Institute Cleveland Ohio United States 44195
    86 The Ohio State University Havener Eye Institute Columbus Ohio United States 43212
    87 Midwest Retina Dublin Ohio United States 43016
    88 Retina Vitreous Center Edmond Oklahoma United States 73013
    89 Retina Northwest Portland Oregon United States 97221
    90 Mid-Atlantic Retina Philadelphia Pennsylvania United States 19107
    91 Palmetto Retina Center Florence South Carolina United States 29501
    92 Retina Consultants Of Carolina Greenville South Carolina United States 29605
    93 Charleston Neuroscience Inst Ladson South Carolina United States 29456
    94 Southeastern Retina Associates Chattanooga Chattanooga Tennessee United States 37421
    95 Charles Retina Institute Memphis Tennessee United States 38119
    96 Tennessee Retina PC Nashville Tennessee United States 37203
    97 Retina Res Institute of Texas Abilene Texas United States 79606
    98 Austin Retina Associates Austin Texas United States 78705
    99 Austin Clinical Research LLC Austin Texas United States 78750
    100 Retina Consultants of Texas Bellaire Texas United States 77401
    101 Texas Retina Associates Dallas Texas United States 75231
    102 Valley Retina Institute P.A. Harlingen Texas United States 78550
    103 Retina & Vitreous of Texas Houston Texas United States 77025
    104 Medical Center Ophthalmology Associates San Antonio Texas United States 78240
    105 Retina Center of Texas Southlake Texas United States 76092
    106 Eye Care Assoc of East Texas Tyler Texas United States 75701
    107 Strategic Clinical Research Group, LLC Willow Park Texas United States 76087
    108 Retina Associates of Utah Salt Lake City Utah United States 84107
    109 University of Utah; Division of Gastroenterology/Hepatology Salt Lake City Utah United States 84132
    110 Uni of Vermont Medical Center; Burlington Vermont United States 05405
    111 Univ of Virginia Ophthalmology Charlottesville Virginia United States 22903
    112 Emerson Clinical Research Institute Falls Church Virginia United States 22042
    113 Piedmont Eye Center Lynchburg Virginia United States 24502
    114 Wagner Macula & Retina Center Norfolk Virginia United States 23502
    115 Retina Institute of Virginia Richmond Virginia United States 23235
    116 West Virginia University Eye Institute Morgantown West Virginia United States 26506
    117 University of Wisconsin Madison Wisconsin United States 53792
    118 Organizacion Medica de Investigacion Buenos Aires Argentina C1015ABO
    119 Fundacion Zambrano Caba Argentina C1017AAO
    120 Oftalmos Capital Federal Argentina C1120AAN
    121 Oftar Mendoza Argentina M5500GGK
    122 Centro Oftalmólogos Especialistas Rosario Argentina S2000ANJ
    123 Grupo Laser Vision Rosario Argentina S2000DLA
    124 Strathfield Retina Clinic Strathfield New South Wales Australia 2135
    125 Sydney Eye Hospital Sydney New South Wales Australia 2000
    126 Sydney Retina Clinic and Day Surgery Sydney New South Wales Australia 2000
    127 Sydney West Retina Westmead New South Wales Australia 2145
    128 Centre For Eye Research Australia East Melbourne Victoria Australia 3002
    129 Retina Specialists Victoria Rowville Victoria Australia 3178
    130 The Lions Eye Institute Nedlands Western Australia Australia 6009
    131 LKH-Univ.Klinikum Graz; Universitäts-Augenklinik Graz Austria 8036
    132 Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde Linz Austria 4021
    133 Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie Wien Austria 1090
    134 Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik Wien Austria 1140
    135 Hospital de Olhos de Aparecida - HOA Aparecida de Goiania GO Brazil 74980-010
    136 Centro Brasileiro de Cirurgia Goiania GO Brazil 74210-010
    137 Hospital das Clinicas - UFRGS Porto Alegre RS Brazil 90035-903
    138 Botelho Hospital da Visao Blumenau SC Brazil 89052-504
    139 Faculdade de Medicina do ABC - FMABC Santo Andre SP Brazil 09060-650
    140 Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia Sao Paulo SP Brazil 04023-062
    141 CEMAPE - Centro Médico Sao Paulo SP Brazil 04084-002
    142 Hospital das Clinicas - FMUSP Sao Paulo SP Brazil 05403-900
    143 Hosp de Olhos de Sorocaba Sorocaba SP Brazil 18031-060
    144 Medical Center for Eye Health - Focus Ltd Sofia Bulgaria 1303
    145 Pentagram Eye Hospital (Medical Center "Pentagram") Sofia Bulgaria 1309
    146 Spec. Ophth. Hospital for Active Treatment- Academic Pashev Sofia Bulgaria 1517
    147 Specialized Hospital for Active Treatment of Eye Diseases Zora Sofia Bulgaria 1784
    148 Calgary Retina Consultants Calgary Alberta Canada T2J 0C8
    149 QEII - HSC Department of Ophthalmology Halifax Nova Scotia Canada B3H 2Y9
    150 Ivey Eye Institute London Ontario Canada N6A 4V2
    151 Toronto Retina Institute Toronto Ontario Canada M3C 0G9
    152 St. Michael's Hospital; Department of Ophthalmology Toronto Ontario Canada M5C 2T2
    153 University Health Network Toronto Western Hospital Toronto Ontario Canada M5T 2S9
    154 Institut De L'Oeil Des Laurentides Boisbriand Quebec Canada J7H 0E8
    155 FN Hradec Králové, Oční klinika; Ophthalmology clinic Hradec Králové Czechia 500 05
    156 Faculty Hospital Ostrava; Ophthalmology clinic Ostrava Czechia 708 52
    157 Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic Prague Czechia 100 34
    158 AXON Clinical Prague Czechia
    159 Nemocnice Sokolov Sokolov Czechia 356 01
    160 Aalborg Universitetshospital; Øjenafdelingen Aalborg Denmark 9000
    161 Sjællands Universitetshospital, Roskilde; Øjenafdelingen Roskilde Denmark 4000
    162 Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin Bordeaux France 33076
    163 Chi De Creteil; Ophtalmologie Creteil France 94010
    164 Pole Vision Val d'Ouest; Ophtalmologie Ecully France 69130
    165 CHU Nantes - Hôtel Dieu; Ophthalmology Nantes France 44093
    166 Hopital Lariboisiere; Ophtalmologie Paris France 75010
    167 Centres Ophtalmologique St Exupéry; Ophtalmologie St Cyr Sur Loire France 37540
    168 Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde Dresden Germany 01307
    169 Universitätsklinikum Freiburg, Klinik für Augenheilkunde Freiburg Germany 79106
    170 Medizinische Hochschule Hannover, Klinik für Augenheilkunde Hannover Germany 30625
    171 Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde Homburg/Saar Germany 66424
    172 Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik Magdeburg Germany 39120
    173 LMU Klinikum der Universität, Augenklinik München Germany 80336
    174 Klinikum rechts der Isar der TU München; Augenklinik München Germany 81675
    175 Augenabteilung am St. Franziskus-Hospital Münster Germany 48145
    176 Universitätsklinikum Münster; Augenheilkunde Münster Germany 48149
    177 Universitätsklinikum Würzburg, Augenklinik und Poliklinik Würzburg Germany 97080
    178 Queen Mary Hospital; Department of Ophthalmology Hong Kong Hong Kong
    179 Hong Kong Eye Hospital; CUHK Eye Centre Mongkok Hong Kong
    180 Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály Budapest Hungary 1068
    181 Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR Budapest Hungary 1076
    182 Semmelweis Egyetem Szemészeti Vizsgálóhely Budapest Hungary 1085
    183 Bajcsy-Zsilinszky Hospital Budapest Hungary 1106
    184 Budapest Retina Associates Kft. Budapest Hungary 1133
    185 Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika Debrecen Hungary 4032
    186 Ganglion Medial Center Pécs Hungary 7621
    187 Szegedi Tudományegyetem ÁOK; Department of Ophtalmology Szeged Hungary 6720
    188 Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET; Intezeti Gyogyszertar Szombathely Hungary 9700
    189 Zala Megyei Kórház; SZEMESZET Zalaegerszeg Hungary 8900
    190 Rambam Medical Center; Opthalmology Haifa Israel 3109601
    191 Hadassah MC; Ophtalmology Jerusalem Israel 9112001
    192 Rabin MC; Ophtalmology Petach Tikva Israel 4941492
    193 Kaplan Medical Center; Ophtalmology Rehovot Israel 7660101
    194 Tel Aviv Sourasky MC; Ophtalmology Tel Aviv Israel 6423906
    195 Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico Roma Lazio Italy 00198
    196 UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA Genova Liguria Italy 16132
    197 Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica Milano Lombardia Italy 20100
    198 Irccs Ospedale San Raffaele;U.O. Oculistica Milano Lombardia Italy 20132
    199 Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica Firenze Toscana Italy 50134
    200 Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria Pisa Toscana Italy 56124
    201 Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica Perugia Umbria Italy 06129
    202 Ospedale Classificato Equiparato Sacro Cuore - Don Calabria; Dipartimento Oculistica Negrar - Verona Veneto Italy 37024
    203 Sugita Eye Hospital Aichi Japan 460-0008
    204 Nagoya University Hospital Aichi Japan 466-8560
    205 Nagoya City University Hospital Aichi Japan 467-8602
    206 Aichi Medical University Hospital Aichi Japan 480-1195
    207 Toho University Sakura Medical Center Chiba Japan 285-8741
    208 Hayashi Eye Hospital Fukuoka Japan 812-0011
    209 Kurume University Hospital Fukuoka Japan 830-0011
    210 Hokkaido University Hospital Hokkaido Japan 060-8648
    211 Asahikawa Medical University Hospital Hokkaido Japan 078-8510
    212 Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC) Hyogo Japan 660-8550
    213 Kozawa eye hospital and diabetes center Ibaraki Japan 310-0845
    214 Ideta Eye Hospital Kumamoto Japan 860-0027
    215 Kyoto University Hospital Kyoto Japan 606-8507
    216 Mie University Hospital Mie Japan 514-8507
    217 University of Miyazaki Hospital Miyazaki Japan 889-1692
    218 Nara Medical University Hospital Nara Japan 634-8522
    219 Kitano Hospital Osaka Japan 530-8480
    220 Osaka Metropolitan University Hospital Osaka Japan 545-8586
    221 National Defense Medical College Hospital Saitama Japan 359-8513
    222 Shiga University Of Medical Science Hospital Shiga Japan 520-2192
    223 Tokyo Women's Medical University Tokyo Japan 162-0054
    224 Kyorin University Hospital Tokyo Japan 181-8611
    225 Tokyo Medical University Hachioji Medical Center Tokyo Japan 193-0998
    226 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13605
    227 Kyung Hee University Hospital Seoul Korea, Republic of 02447
    228 Seoul National University Hospital Seoul Korea, Republic of 03080
    229 Asan Medical Center Seoul Korea, Republic of 05505
    230 Samsung Medical Center Seoul Korea, Republic of 06351
    231 Centro Oftalmológico Mira, S.C Del. Cuauhtemoc Mexico CITY (federal District) Mexico 06760
    232 Instituto de la retina del Bajio Querétaro Queretaro Mexico 76180
    233 Macula Retina Consultores Mexico, D.F. Mexico 01120
    234 Hospital de la Ceguera APEC Mexico, D.F. Mexico 04030
    235 Mácula D&T Lima Peru 27
    236 TG Laser Oftalmica Lima Peru 27
    237 Oftalmolaser Lima Peru Lima 33
    238 Szpital sw. Lukasza Bielsko-Biala Poland 43-309
    239 OFTALMIKA Sp. z o.o Bydgoszcz Poland 85-631
    240 Specjalistyczny Ośrodek Okulistyczny Oculomedica Bydgoszcz Poland 85-870
    241 Szpital Specjalistyczny nr 1; Oddzial Okulistyki Bytom Poland 41-902
    242 Dobry Wzrok Sp Z O O Gdańsk Poland 80-402
    243 Optimum Profesorskie Centrum Okulistyki Gdańsk Poland 80-809
    244 Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT Gliwice Poland 44-100
    245 Gabinet Okulistyczny Prof Edward Wylegala Katowice Poland 40-594
    246 Centrum Medyczne UNO-MED Krakow Poland 31-070
    247 SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej Krakow Poland 31-501
    248 Optomed Sp. z o.o. Rybnik Poland 44-203
    249 Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow Rzeszów Poland 35-017
    250 Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki Rzeszów Poland 35-055
    251 Caminomed Tarnowskie Góry Poland 42-600
    252 Centrum Zdrowia MDM Warszawa Poland 00-631
    253 SPEKTRUM Osrodek Okulistyki Klinicznej Wroclaw Poland 53-334
    254 Hospital de Braga; Servico de Oftalmologia Braga Portugal 4710-243
    255 AIBILI - Association for Innovation and Biomedical Research on Light Coimbra Portugal 3000-548
    256 Espaco Medico Coimbra Coimbra Portugal 3030-163
    257 Hospital de Santa Maria; Servico de Oftalmologia Lisboa Portugal 1649-035
    258 Clinic Optimed UFA Baskortostan Russian Federation 450059
    259 Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch Cheboksary Marij EL Russian Federation 428000
    260 Clinics of Eye Diseases, LLC Kazan Tatarstan Russian Federation 420066
    261 "Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch Irkutsk Russian Federation 664033
    262 FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences Moscow Russian Federation 119435
    263 "Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch Novosibirsk Russian Federation 630096
    264 Medical Military Academy n.a S.M.Kirov St.Petersburg Russian Federation 194044
    265 National University Hospital; Ophthalmology Department Singapore Singapore 119074
    266 Singapore Eye Research Institute Singapore Singapore 168751
    267 Tan Tock Seng Hospital; Ophthalmology Department Singapore Singapore 308433
    268 Nemocnica s poliklinikou Trebišov, a.s. Trebišov Slovakia 075 01
    269 Fakultna nemocnica Trencin Ocna klinika Trencin Slovakia 911 71
    270 Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie Zilina Slovakia 012 07
    271 Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia Oviedo Asturias Spain 33012
    272 Hospital Universitario de Bellvitge Hospitalet de Llobregat Barcelona Spain 08907
    273 Hospital General de Catalunya San Cugat Del Valles Barcelona Spain 08195
    274 Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia Santiago de Compostela LA Coruña Spain 15706
    275 Hospital Universitario de Gran Canaria; Servicio de oftalmologia Las Palmas de Gran Canaria LAS Palmas Spain 35016
    276 Hospital Universitario Puerta de Hierro Majadahonda Madrid Spain 28222
    277 Clinica Universitaria de Navarra; Servicio de Oftalmologia Pamplona Navarra Spain 31008
    278 Complejo Hospitalario de Navarra; Servicio de oftalmologia Pamplona Navarra Spain 31008
    279 Oftalvist Valencia Burjassot Valencia Spain 46100
    280 Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia Albacete Spain 02006
    281 VISSUM Instituto Oftalmológico de Alicante Alicante Spain 03016
    282 Centro de Oftalmologia Barraquer; Servicio Oftalmologia Barcelona Spain 08021
    283 Hospital dos de maig; servicio de oftalmologia Barcelona Spain 08025
    284 Hospital Clinic de Barcelona; Consultas Externas Oftalmologia Barcelona Spain 08028
    285 Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia Barcelona Spain 08041
    286 Clinica Baviera; Servicio Oftalmologia Madrid Spain 28046
    287 Fisabio-Ofalmologia Medica; Servicio de Oftalmología Valencia Spain 46015
    288 Hospital Universitario Rio Hortega; Servicio de Oftalmologia Valladolid Spain 47012
    289 Vista Klinik Ophthalmologische Klinik Binningen Switzerland 4102
    290 Taipei Veterans General Hospital; Ophthalmology Taipei Taiwan 11217
    291 Chang Gung Medical Foundation - Linkou; Ophthalmology Taoyuan Taiwan 333
    292 National Taiwan University Hospital; Ophthalmology Zhongzheng Dist. Taiwan 10002
    293 King Chulalongkorn Memorial Hospital; Ophthalmology Department Bangkok Thailand 10330
    294 Rajavithi Hospital; Ophthalmology Department Bangkok Thailand 10400
    295 Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department ChiangMai Thailand 50200
    296 Hacettepe University Medical Faculty; Department of Ophthalmology Ankara Turkey 06100
    297 Ankara University Medical Faculty; Department of Ophthalmology Ankara Turkey 06340
    298 Ankara Baskent University Medical Faculty; Department of Ophthalmology Ankara Turkey 06490
    299 Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology Istanbul Turkey 34421
    300 Ege University Medical Faculty; Department of Ophthalmology Izmir Turkey 35100
    301 Kocaeli Üniversitesi Tıp Fakültesi; Department of Ophthalmology Kocaeli Turkey 41380
    302 Selcuk University Faculty of Medicine; Department Of Ophthalmology Konya Turkey 42130
    303 Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL Belfast United Kingdom BT12 6BA
    304 Bradford Royal Infirmary Bradford United Kingdom BD9 6RJ
    305 East Kent Hospitals University NHS Foundation Trust Canterbury United Kingdom CT1 3NG
    306 Frimley Park Hospital Frimley United Kingdom GU16 7UJ
    307 Gloucestershire Hospitals NHS Foundation Trust Gloucestershire United Kingdom GL1 3NN
    308 St James University Hospital Leeds United Kingdom LS9 7TF
    309 Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre Liverpool United Kingdom L7 8XP
    310 Moorfields Eye Hospital NHS Foundation Trust London United Kingdom EC1V 2PD
    311 Royal Free Hospital London United Kingdom NW3 2QS
    312 Kings College Hospital London United Kingdom SW9 8RR
    313 Manchester Royal Eye Hospital Manchester United Kingdom M13 9WL
    314 Hillingdon Hospital Middx United Kingdom UB8 3NN
    315 Royal Victoria Infirmary Newcastle upon Tyne United Kingdom NE1 4LP
    316 James Paget University Hospitals NHS Foundation Trust Norfolk United Kingdom NR31 6LA
    317 University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit Southampton United Kingdom SO16 6YD
    318 Sunderland Eye Infirmary Sunderland United Kingdom SR2 9HP

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04432831
    Other Study ID Numbers:
    • GR41987
    • 2020-000402-29
    First Posted:
    Jun 16, 2020
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 8, 2022