COMINO: A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2) In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen). |
Drug: Faricimab
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
Other Names:
Procedure: Sham Procedure
The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
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Active Comparator: Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2) In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen). |
Drug: Faricimab
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
Other Names:
Drug: Aflibercept
Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
Other Names:
Procedure: Sham Procedure
The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
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Outcome Measures
Primary Outcome Measures
- Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 24 [Baseline and Week 24]
Secondary Outcome Measures
- Part 1: Change from Baseline in BCVA at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 24 [Baseline and Week 24]
- Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Specified Timepoints Through Week 24 [Baseline, Weeks 4, 8, 12, 16, 20, and 24]
- Part 2: Change from Baseline in BCVA at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 72 [Baseline and Week 72]
- Part 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Baseline at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints from Week 24 Through Week 72 [Every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better at Specified Timepoints from Week 24 Through Week 72 [Every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse at Specified Timepoints from Week 24 Through Week 72 [Every 4 weeks from Week 24 to Week 72]
- Part 2: Change from Week 24 in BCVA at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72 [Every 4 weeks from Week 24 to Week 72]
- Part 2: Percentage of Participants on Different Treatment Intervals at Week 72 [Week 72]
- Part 2: Number of Study Drug Injections Received from Week 24 Through Week 72 [From Week 24 to Week 72]
- Part 2: Change from Baseline in Central Subfield Thickness at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]
- Part 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints from Week 24 Through Week 72 [Baseline and every 4 weeks from Week 24 to Week 72]
- Incidence and Severity of Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [From Baseline until end of study (up to 72 weeks)]
- Incidence and Severity of Non-Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale [From Baseline until end of study (up to 72 weeks)]
- Plasma Concentration of Faricimab Over Time [Predose at Day 1, Weeks 4, 24, 28, 52, and 72]
- Number of Participants with Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study [Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent)
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Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
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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:
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Any major illness or major surgical procedure within 1 month before screening
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Uncontrolled blood pressure
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Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
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Pregnant or breastfeeding, or intending to become pregnant during the study
Ocular Exclusion Criteria for Study Eye:
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History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
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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)
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Macular laser (focal/grid) in the study eye at any time prior to Day 1
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Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
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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
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Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheathotomy
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Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)
Ocular Exclusion Criteria for Both Eyes:
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Prior IVT administration of faricimab in either eye
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History of idiopathic or autoimmune-associated uveitis in either eye
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Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Barnet Dulaney Perkins Eye Center | Mesa | Arizona | United States | 85206 |
2 | Retinal Research Institute, LLC | Phoenix | Arizona | United States | 85014 |
3 | Retina Associates Southwest PC | Tucson | Arizona | United States | 85704 |
4 | Retinal Diagnostic Center | Campbell | California | United States | 95008 |
5 | The Retina Partners | Encino | California | United States | 91436 |
6 | Retina Consultants of Orange County | Fullerton | California | United States | 92835 |
7 | Northern California Retina Vitreous Associates | Mountain View | California | United States | 94040 |
8 | East Bay Retina Consultants | Oakland | California | United States | 94609 |
9 | California Eye Specialists Medical group Inc. | Pasadena | California | United States | 91107 |
10 | Retina Consultants, San Diego | Poway | California | United States | 92064 |
11 | West Coast Retina Medical Group | San Francisco | California | United States | 94109 |
12 | Retina Consultants of Southern Colorado PC | Colorado Springs | Colorado | United States | 80909 |
13 | Colorado Retina Associates, PC | Lakewood | Colorado | United States | 80228 |
14 | Retina Group of New England | Waterford | Connecticut | United States | 06385 |
15 | Advanced Research | Coral Springs | Florida | United States | 33067 |
16 | Rand Eye | Deerfield Beach | Florida | United States | 33064 |
17 | Florida Eye Associates | Melbourne | Florida | United States | 32901 |
18 | Fort Lauderdale Eye Institute | Plantation | Florida | United States | 33324 |
19 | Retina Vitreous Assoc of FL | Saint Petersburg | Florida | United States | 33711 |
20 | Retina Associates of Florida, LLC | Tampa | Florida | United States | 33609 |
21 | Southeast Retina Center | Augusta | Georgia | United States | 30909 |
22 | Georgia Retina PC | Marietta | Georgia | United States | 30060 |
23 | Retina Consultants of Hawaii | 'Aiea | Hawaii | United States | 96701 |
24 | Northwestern Medical Group/Northwestern University | Chicago | Illinois | United States | 60611 |
25 | Retina Associated Ltd | Elmhurst | Illinois | United States | 60126 |
26 | University Retina and Macula Associates, PC | Lemont | Illinois | United States | 60439 |
27 | Prairie Retina Center | Springfield | Illinois | United States | 62704 |
28 | Retina Associates | Lenexa | Kansas | United States | 66215 |
29 | Maine Eye Center | Portland | Maine | United States | 04101 |
30 | Johns Hopkins Med; Wilmer Eye Inst | Baltimore | Maryland | United States | 21287 |
31 | Retina Group of Washington | Chevy Chase | Maryland | United States | 20815 |
32 | Cumberland Valley Retina PC | Hagerstown | Maryland | United States | 21740 |
33 | Assoc Retinal Consultants PC | Royal Oak | Michigan | United States | 48073 |
34 | VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota | Edina | Minnesota | United States | 55435 |
35 | Midwest Vision Research Foundation | Chesterfield | Missouri | United States | 63017 |
36 | Sierra Eye Associates | Reno | Nevada | United States | 89502 |
37 | Mid Atlantic Retina - Wills Eye Hospital | Cherry Hill | New Jersey | United States | 08034 |
38 | Long Is. Vitreoretinal Consult | Great Neck | New York | United States | 11021 |
39 | Retina Vit Surgeons/Central NY | Liverpool | New York | United States | 13088 |
40 | Retina Assoc of Western NY | Rochester | New York | United States | 14620 |
41 | Cincinnati Eye Institute | Cincinnati | Ohio | United States | 45242 |
42 | Cascade Medical Research Institute LLC | Eugene | Oregon | United States | 97401 |
43 | Retina Northwest | Portland | Oregon | United States | 97221 |
44 | Palmetto Retina Center | Florence | South Carolina | United States | 29501 |
45 | Charleston Neuroscience Institute | Ladson | South Carolina | United States | 29456 |
46 | Black Hills Eye Institute | Rapid City | South Dakota | United States | 57701 |
47 | Charles Retina Institute | Memphis | Tennessee | United States | 38119 |
48 | Tennessee Retina PC | Nashville | Tennessee | United States | 37203 |
49 | Retina Res Institute of Texas | Abilene | Texas | United States | 79606 |
50 | Austin Retina Associates | Austin | Texas | United States | 78705 |
51 | Austin Clinical Research LLC | Austin | Texas | United States | 78750 |
52 | Retina Consultants of Texas | Bellaire | Texas | United States | 77401 |
53 | Texas Retina Associates | Dallas | Texas | United States | 75231 |
54 | Retina & Vitreous of Texas | Houston | Texas | United States | 77025 |
55 | Strategic Clinical Research Group, LLC | Willow Park | Texas | United States | 76087 |
56 | Retina Associates of Utah | Salt Lake City | Utah | United States | 84107 |
57 | Piedmont Eye Center | Lynchburg | Virginia | United States | 24502 |
58 | West Virginia University Eye Institute | Morgantown | West Virginia | United States | 26506 |
59 | Organizacion Medica de Investigacion | Buenos Aires | Argentina | C1015ABO | |
60 | Fundacion Zambrano | Caba | Argentina | C1017AAO | |
61 | Centro Oftalmológico Dr. Charles S.A. | Capital Federal | Argentina | C1015ABO | |
62 | Oftalmos | Capital Federal | Argentina | C1120AAN | |
63 | Hospital Italiano; Ophtalmology | Capital Federal | Argentina | C1199ABC | |
64 | Buenos Aires Mácula | Ciudad Autonoma Buenos Aires | Argentina | C1061AAE | |
65 | Oftar | Mendoza | Argentina | M5500GGK | |
66 | Centro Oftalmólogos Especialistas | Rosario | Argentina | S2000ANJ | |
67 | Grupo Laser Vision | Rosario | Argentina | S2000DLA | |
68 | Eyeclinic Albury Wodonga | Albury | New South Wales | Australia | 2640 |
69 | Strathfield Retina Clinic | Strathfield | New South Wales | Australia | 2135 |
70 | Save Sight Institute | Sydney | New South Wales | Australia | 2000 |
71 | Sydney Retina Clinic and Day Surgery | Sydney | New South Wales | Australia | 2000 |
72 | Centre For Eye Research Australia | East Melbourne | Victoria | Australia | 3002 |
73 | Retina Specialists Victoria | Rowville | Victoria | Australia | 3178 |
74 | The Lions Eye Institute | Nedlands | Western Australia | Australia | 6009 |
75 | LKH-Univ.Klinikum Graz; Universitäts-Augenklinik | Graz | Austria | 8036 | |
76 | Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie | Wien | Austria | 1090 | |
77 | Hospital de Olhos de Aparecida - HOA | Aparecida de Goiania | GO | Brazil | 74980-010 |
78 | Hospital das Clinicas - UFRGS | Porto Alegre | RS | Brazil | 90035-903 |
79 | Botelho Hospital da Visao | Blumenau | SC | Brazil | 89052-504 |
80 | Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia | Sao Paulo | SP | Brazil | 04023-062 |
81 | Hosp de Olhos de Sorocaba | Sorocaba | SP | Brazil | 18031-060 |
82 | Beijing Hospital of Ministry of Health | Beijing | China | 100730 | |
83 | The Second Hospital of Jilin University | Changchun | China | 130041 | |
84 | West China Hospital, Sichuan University | Chengdu | China | 610041 | |
85 | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou City | China | 510060 | |
86 | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou City | China | 310009 | |
87 | The 2nd Affiliated Hospital of Harbin Medical University | Harbin | China | 150001 | |
88 | Shanghai Tenth People's Hospital | Shanghai | China | 200072 | |
89 | Shanghai First People's Hospital | Shanghai | China | 200080 | |
90 | He Eye Specialist Shenyang Hospital | Shenyang City | China | 110034 | |
91 | Tianjin Eye Hospital | Tianjin City | China | 300050 | |
92 | Tianjin Medical University Eye Hospital | Tianjin City | China | 300070 | |
93 | Eye Hospital, Wenzhou Medical University | Wenzhou City | China | 325027 | |
94 | Renmin Hospital of Wuhan University | Wuhan | China | 430060 | |
95 | Henan Provincial Eye Hosptial | Zhengzhou | China | ||
96 | General Teaching Hospital Prague; Ophthalmology clinic | Prague | Czechia | 128 08 | |
97 | AXON Clinical | Prague | Czechia | ||
98 | Chi De Creteil; Ophtalmologie | Creteil | France | 94010 | |
99 | Hopital Lariboisiere; Ophtalmologie | Paris | France | 75010 | |
100 | Centre Ophtalmologique; Imagerie et laser | Paris | France | 75015 | |
101 | Centres Ophtalmologique St Exupéry; Ophtalmologie | St Cyr Sur Loire | France | 37540 | |
102 | Internationale Innovative Ophthalmochirurgie GbR; c/o Makula-Netzhaut-Zentrum Breyer Kaymak Klabe | Düsseldorf-Oberkassel | Germany | 40549 | |
103 | Universitätsklinikum Freiburg, Klinik für Augenheilkunde | Freiburg | Germany | 79106 | |
104 | Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik | Ludwigshafen | Germany | 67063 | |
105 | Queen Mary Hospital; Department of Ophthalmology | Hong Kong | Hong Kong | ||
106 | Hong Kong Eye Hospital; CUHK Eye Centre | Mongkok | Hong Kong | ||
107 | Bajcsy-Zsilinszky Hospital | Budapest | Hungary | 1106 | |
108 | Budapest Retina Associates Kft. | Budapest | Hungary | 1133 | |
109 | Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika | Debrecen | Hungary | 4032 | |
110 | Szegedi Tudományegyetem ÁOK; Department of Ophtalmology | Szeged | Hungary | 6720 | |
111 | Zala Megyei Kórház; SZEMESZET | Zalaegerszeg | Hungary | 8900 | |
112 | Rambam Medical Center; Opthalmology | Haifa | Israel | 3109601 | |
113 | Hadassah MC; Ophtalmology | Jerusalem | Israel | 9112001 | |
114 | Rabin MC; Ophtalmology | Petach Tikva | Israel | 4941492 | |
115 | Kaplan Medical Center; Ophtalmology | Rehovot | Israel | 7660101 | |
116 | Tel Aviv Sourasky MC; Ophtalmology | Tel Aviv | Israel | 6423906 | |
117 | Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico | Roma | Lazio | Italy | 00198 |
118 | Irccs Ospedale San Raffaele;U.O. Oculistica | Milano | Lombardia | Italy | 20132 |
119 | Sugita Eye Hospital | Aichi | Japan | 460-0008 | |
120 | Nagoya University Hospital | Aichi | Japan | 466-8560 | |
121 | Nagoya City University Hospital | Aichi | Japan | 467-8602 | |
122 | Aichi Medical University Hospital | Aichi | Japan | 480-1195 | |
123 | Toho University Sakura Medical Center | Chiba | Japan | 285-8741 | |
124 | Hayashi Eye Hospital | Fukuoka | Japan | 812-0011 | |
125 | Kurume University Hospital | Fukuoka | Japan | 830-0011 | |
126 | Fukushima Medical University Hospital | Fukushima | Japan | 960-1295 | |
127 | Asahikawa Medical University Hospital | Hokkaido | Japan | 078-8510 | |
128 | Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC) | Hyogo | Japan | 660-8550 | |
129 | Hyogo Medical University Hospital | Hyogo | Japan | 663-8501 | |
130 | Kozawa eye hospital and diabetes center | Ibaraki | Japan | 310-0845 | |
131 | Kagawa University Hospital | Kagawa | Japan | 761-0793 | |
132 | Kagoshima University Hospital | Kagoshima | Japan | 890-8520 | |
133 | Mie University Hospital | Mie | Japan | 514-8507 | |
134 | Shinshu University Hospital | Nagano | Japan | 390-8621 | |
135 | Osaka Metropolitan University Hospital | Osaka | Japan | 545-8586 | |
136 | Kansai Medical University Medical Center | Osaka | Japan | 570-8507 | |
137 | Tokyo Women's Medical University Hospital | Tokyo | Japan | 162-8666 | |
138 | Tokyo Medical University Hachioji Medical Center | Tokyo | Japan | 193-0998 | |
139 | Pusan National University Hospital | Busan | Korea, Republic of | 49241 | |
140 | Yeungnam University Medical Center | Daegu | Korea, Republic of | 42415 | |
141 | Seoul National University Bundang Hospital | Seongnam-si | Korea, Republic of | 13605 | |
142 | Kyung Hee University Hospital | Seoul | Korea, Republic of | 02447 | |
143 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
144 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
145 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
146 | Kim's Eye Hospital | Seoul | Korea, Republic of | 07301 | |
147 | Szpital sw. Lukasza | Bielsko-Biala | Poland | 43-309 | |
148 | OFTALMIKA Sp. z o.o | Bydgoszcz | Poland | 85-631 | |
149 | Specjalistyczny Ośrodek Okulistyczny Oculomedica | Bydgoszcz | Poland | 85-870 | |
150 | Szpital Specjalistyczny nr 1; Oddzial Okulistyki | Bytom | Poland | 41-902 | |
151 | Dobry Wzrok Sp Z O O | Gdańsk | Poland | 80-402 | |
152 | Optimum Profesorskie Centrum Okulistyki | Gdańsk | Poland | 80-809 | |
153 | Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT | Gliwice | Poland | 44-100 | |
154 | Gabinet Okulistyczny Prof Edward Wylegala | Katowice | Poland | 40-594 | |
155 | SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej | Krakow | Poland | 31-501 | |
156 | Centrum Medyczne Dietla 19 Sp. Z O.O. | Kraków | Poland | 31-070 | |
157 | MT Medic Krosno | Krosno | Poland | 38-400 | |
158 | Ośrodek Chirurgii Oka Prof. Zagórskiego Nałęczów | Nałęczów | Poland | 24-140 | |
159 | Centrum Medyczne Pulawska SP. z o.o. | Piaseczno | Poland | 05-500 | |
160 | Lens Clinic | Rybnik | Poland | 44-203 | |
161 | Caminomed | Tarnowskie Góry | Poland | 42-600 | |
162 | Centrum Zdrowia MDM | Warszawa | Poland | 00-631 | |
163 | SPEKTRUM Osrodek Okulistyki Klinicznej | Wroclaw | Poland | 53-334 | |
164 | Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia | Coimbra | Portugal | 3000-075 | |
165 | Espaco Medico Coimbra | Coimbra | Portugal | 3030-163 | |
166 | Hospital de Santa Maria; Servico de Oftalmologia | Lisboa | Portugal | 1649-035 | |
167 | Clinic Optimed | UFA | Baskortostan | Russian Federation | 450059 |
168 | Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch | Cheboksary | Marij EL | Russian Federation | 428000 |
169 | FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences | Moscow | Russian Federation | 119435 | |
170 | 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology | Saint Petersburg | Russian Federation | 197022 | |
171 | Medical Military Academy n.a S.M.Kirov | St.Petersburg | Russian Federation | 194044 | |
172 | Singapore Eye Research Institute | Singapore | Singapore | 168751 | |
173 | Tan Tock Seng Hospital; Ophthalmology Department | Singapore | Singapore | 308433 | |
174 | Hospital Universitario de Bellvitge | Hospitalet de Llobregat | Barcelona | Spain | 08907 |
175 | Hospital General de Catalunya | San Cugat Del Valles | Barcelona | Spain | 08195 |
176 | Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | Spain | 28222 |
177 | Complejo Hospitalario de Navarra; Servicio de oftalmologia | Pamplona | Navarra | Spain | 31008 |
178 | Centro de Oftalmologia Barraquer; Servicio Oftalmologia | Barcelona | Spain | 08021 | |
179 | Hospital Clinic de Barcelona; Consultas Externas Oftalmologia | Barcelona | Spain | 08028 | |
180 | Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia | Barcelona | Spain | 08041 | |
181 | Hospital Universitario Rio Hortega; Servicio de Oftalmologia | Valladolid | Spain | 47012 | |
182 | Changhua Christian Hospital; Department of Ophthalmology | Changhua | Taiwan | 500 | |
183 | Taipei Veterans General Hospital; Ophthalmology | Taipei | Taiwan | 11217 | |
184 | Chang Gung Medical Foundation - Linkou; Ophthalmology | Taoyuan | Taiwan | 333 | |
185 | Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL | Belfast | United Kingdom | BT12 6BA | |
186 | Birmingham Midland Eye Centre | Birmingham | United Kingdom | B18 7QH | |
187 | Opthalmology Research Office | Bradford | United Kingdom | BD9 6RJ | |
188 | Bristol Eye Hospital;Retinal Treatment and Research Unit | Bristol | United Kingdom | BS1 2LX | |
189 | University Hospital of Wales | Cardiff | United Kingdom | CF14 4XW | |
190 | St James University Hospital | Leeds | United Kingdom | LS9 7TF | |
191 | Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre | Liverpool | United Kingdom | L7 8XP | |
192 | Central Middlesex Hospital | London | United Kingdom | NW10 7NS | |
193 | Maidstone and Tunbridge Wells NHS Trust | Maidstone | United Kingdom | ME16 9QQ | |
194 | Royal Victoria Infirmary | Newcastle upon Tyne | United Kingdom | NE1 4LP |
Sponsors and Collaborators
- Hoffmann-La Roche
- Chugai Pharmaceutical
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GR41986
- 2020-000441-13