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A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03622580
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Aflibercept Drug: Faricimab Drug: Sham Procedure Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of RO6867461 in Patients With Diabetic Macular Edema (YOSEMITE)
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : June 2, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: A: Faricimab Q8W Drug: Faricimab
Faricimab will be administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or as specified in the protocol in arm B.
Other Name: RO6867461; RG7716

Drug: 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. It will be administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.

Experimental: B: Faricimab As Specified in Protocol Drug: Faricimab
Faricimab will be administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or as specified in the protocol in arm B.
Other Name: RO6867461; RG7716

Drug: 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. It will be administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.

Active Comparator: C: Aflibercept Q8W Drug: Aflibercept
Aflibercept will be administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
Other Name: Eylea

Drug: 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. It will be administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.




Primary Outcome Measures :
  1. Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) at 1 Year [ Time Frame: Baseline (Day 1) and 1 year ]
    As measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.


Secondary Outcome Measures :
  1. Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at 1 Year [ Time Frame: Baseline and 1 year ]
  2. Change From Baseline in BCVA Over Time [ Time Frame: From Baseline up to 2 years ]
  3. Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  4. Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  5. Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  6. Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  7. Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  8. Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  9. Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  10. Percentage of Participants Avoiding a Loss of ≥0 Letters in BCVA From Baseline Over Time [ Time Frame: From Baseline up to 2 years ]
  11. Percentage of Participants With a ≥2-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time [ Time Frame: From Baseline up to 2 years ]
  12. Percentage of Participants With a ≥3-Step DRS Improvement From Baseline on the ETDRS DRSS Over Time [ Time Frame: From Baseline up to 2 years ]
  13. Percentage of Participants Gaining ≥15 Letters or Achieving BCVA of ≥84 Letters Over Time [ Time Frame: Up to 2 years ]
  14. Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time [ Time Frame: Up to 2 years ]
  15. Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time [ Time Frame: Up to 2 years ]
  16. Percentage of Participants Who Develop New Proliferative Diabetic Retinopathy Over Time [ Time Frame: Up to 2 years ]
  17. Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 1 Year [ Time Frame: 1 year ]
  18. Percentage of Participants in the Faricimab As Specified in Protocol Arm on a Q4W, Q8W, Q12W, or Q16W Treatment Interval at 2 Years [ Time Frame: 2 years ]
  19. Change From Baseline in Central Subfield Thickness (CST) Over Time [ Time Frame: From Baseline up to 2 years ]
  20. Percentage of Participants with Absence of DME Over Time [ Time Frame: Up to 2 years ]
  21. Percentage of Participants with Absence of Intraretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  22. Percentage of Participants with Absence of Subretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  23. Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid Over Time [ Time Frame: Up to 2 years ]
  24. Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time [ Time Frame: From Baseline up to 2 years ]
  25. Percentage of Participants With Ocular Adverse Events [ Time Frame: Up to 2 years ]
  26. Percentage of Participants With Non-Ocular Adverse Events [ Time Frame: Up to 2 years ]
  27. Plasma Concentration of Faricimab Over Time [ Time Frame: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years) ]
  28. Percentage of Participants With Presence of Anti-Drug Antibodies [ Time Frame: Pre-dose on Day 1; Weeks 4, 28, 52, 76, and 100; and at Early Termination Visit (up to 2 years) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus and hemoglobin A1c (HbA1c) of less than or equal to (≤) 10%
  • Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
  • Decreased visual acuity attributable primarily to DME
  • Ability and willingness to undertake all scheduled visits and assessments
  • 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:

  • Currently untreated diabetes mellitus or previously untreated patients who initiated oral anti-diabetic medication or insulin within 3 months prior to Day 1
  • Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
  • Currently pregnant or breastfeeding, or intend to become pregnant during the study
  • Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
  • Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye
  • Prior administration of IVT faricimab in either eye
  • Active intraocular or periocular infection or active intraocular inflammation in the study eye
  • Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
  • 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 DME in the study eye
  • Other protocol-specified inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03622580


Contacts
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Contact: Reference Study ID Number: GR40349 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

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Locations
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United States, Arizona
Arizona Retina and Vitreous Consultants Recruiting
Phoenix, Arizona, United States, 85021
Barnet Dulaney Perkins Eye Center Recruiting
Sun City, Arizona, United States, 85351
Retina Associates Southwest PC Recruiting
Tucson, Arizona, United States, 85750
United States, California
Retinal Diagnostic Center Active, not recruiting
Campbell, California, United States, 95008
Eye Medical Center Recruiting
Fresno, California, United States, 93720
Jules Stein Eye Institute/ UCLA Recruiting
Los Angeles, California, United States, 90095-7000
East Bay Retina Consultants Active, not recruiting
Oakland, California, United States, 94609
Southern CA Desert Retina Cons Recruiting
Palm Desert, California, United States, 92211
Byers Eye Institute at Stanford University Recruiting
Palo Alto, California, United States, 94303
California Eye Specialists Recruiting
Pasadena, California, United States, 91107
Retina Consultants, San Diego Recruiting
Poway, California, United States, 92064
Retina Consultants of Southern California Recruiting
Redlands, California, United States, 92373
Kaiser Permanente Riverside Medical Center Recruiting
Riverside, California, United States, 92505
University of California, Davis, Eye Center Recruiting
Sacramento, California, United States, 95817
W Coast Retina Med Group Inc Recruiting
San Francisco, California, United States, 94107
Orange County Retina Med Group Recruiting
Santa Ana, California, United States, 92705
United States, Colorado
Colorado Retina Associates, PC Recruiting
Golden, Colorado, United States, 80401
United States, Florida
Rand Eye Recruiting
Deerfield Beach, Florida, United States, 33064
Retina Health Center Recruiting
Fort Myers, Florida, United States, 33907
Retina Care Specialists Recruiting
Palm Beach Gardens, Florida, United States, 33410
Retina Specialty Institute Recruiting
Pensacola, Florida, United States, 32503
Southern Vitreoretinal Assoc Recruiting
Tallahassee, Florida, United States, 32308
Retina Associates of Florida, LLC Recruiting
Tampa, Florida, United States, 33609
University of South Florida Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Georgia Retina PC Recruiting
Marietta, Georgia, United States, 30060
United States, Hawaii
Retina Consultants of Hawaii Active, not recruiting
'Aiea, Hawaii, United States, 96701
United States, Illinois
University of Illinois at Chicago College of Medicine; Illilnois Eye and Ear Infirmary Recruiting
Chicago, Illinois, United States, 60612
United States, Indiana
Midwest Eye Institute Recruiting
Indianapolis, Indiana, United States, 46290
United States, Iowa
Wolfe Eye Clinic Recruiting
West Des Moines, Iowa, United States, 50266
United States, Kansas
Retina Associates Recruiting
Shawnee Mission, Kansas, United States, 66204
Vitreo-Retinal Consultants Recruiting
Wichita, Kansas, United States, 67214
United States, Kentucky
Retina Associates of Kentucky Recruiting
Lexington, Kentucky, United States, 40509
KY Lions Eye Center Not yet recruiting
Louisville, Kentucky, United States, 40202
Paducah Retinal Center Recruiting
Paducah, Kentucky, United States, 42001
United States, Maine
Maine Eye Center Recruiting
Portland, Maine, United States, 04101
United States, Maryland
The Retina Care Center Recruiting
Baltimore, Maryland, United States, 21209
Johns Hopkins Med; Wilmer Eye Inst Active, not recruiting
Baltimore, Maryland, United States, 21287
Retina Group of Washington Recruiting
Chevy Chase, Maryland, United States, 20815
Cumberland Valley Retina PC Active, not recruiting
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Ophthalmic Consultants of Boston Active, not recruiting
Boston, Massachusetts, United States, 02114
Beetham Eye Institute, Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Vitreo-Retinal Associates, PC Recruiting
Worcester, Massachusetts, United States, 01605
United States, Michigan
Foundation for Vision Research Recruiting
Grand Rapids, Michigan, United States, 49546
Assoc Retinal Consultants PC Active, not recruiting
Royal Oak, Michigan, United States, 48073
Associated Retinal Consultants, P.C. Recruiting
Traverse City, Michigan, United States, 49686
United States, Minnesota
Vitreoretinal Surgery Recruiting
Edina, Minnesota, United States, 55435
United States, Missouri
Lifelong Vision Foundation Recruiting
Chesterfield, Missouri, United States, 63017
United States, Nevada
Sierra Eye Associates Recruiting
Reno, Nevada, United States, 89502
United States, New Jersey
Mid Atlantic Retina - Wills Eye Hospital Recruiting
Cherry Hill, New Jersey, United States, 08034
New Jersey Retina Research Foundation Active, not recruiting
Edison, New Jersey, United States, 08820
Retinal & Ophthalmic Cons PC Recruiting
Northfield, New Jersey, United States, 08225
Retina Associates of NJ Recruiting
Teaneck, New Jersey, United States, 07666
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Capital Region Retina Active, not recruiting
Albany, New York, United States, 12206
Long Is. Vitreoretinal Consult Recruiting
Hauppauge, New York, United States, 11788
MaculaCare, PLLC Recruiting
New York, New York, United States, 10021
Island Retina Recruiting
Shirley, New York, United States, 11967
Retina Vit Surgeons/Central NY Recruiting
Syracuse, New York, United States, 13224
United States, North Carolina
Western Carolina Retinal Associate PA Active, not recruiting
Asheville, North Carolina, United States, 28803
Char Eye Ear &Throat Assoc Recruiting
Charlotte, North Carolina, United States, 28210
Carolina Eye Associates Recruiting
Southern Pines, North Carolina, United States, 28387
Graystone Eye Active, not recruiting
Winston-Salem, North Carolina, United States, 27104
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cincinnati Eye Institute Recruiting
Cincinnati, Ohio, United States, 45242
Retina Assoc of Cleveland Inc Recruiting
Cleveland, Ohio, United States, 44122
OSU Eye Physicians & Surgeons Recruiting
Columbus, Ohio, United States, 43212
Midwest Retina Recruiting
Dublin, Ohio, United States, 43016
United States, Oklahoma
Retina Vitreous Center Recruiting
Edmond, Oklahoma, United States, 73013
United States, Oregon
Retina Northwest Recruiting
Portland, Oregon, United States, 97221
United States, South Dakota
Black Hills Eye Institute Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Charles Retina Institution Recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
Retina Res Institute of Texas Recruiting
Abilene, Texas, United States, 79606
Retina Research Center Recruiting
Austin, Texas, United States, 78705
Texas Retina Associates Active, not recruiting
Dallas, Texas, United States, 75231
Retina Specialists Recruiting
DeSoto, Texas, United States, 75115
Retina & Vitreous of Texas Active, not recruiting
Houston, Texas, United States, 77025
Valley Retina Institute P.A. Recruiting
McAllen, Texas, United States, 78503
Med Center Ophthalmology Assoc Recruiting
San Antonio, Texas, United States, 78240
Retina Consultants of Houston Recruiting
The Woodlands, Texas, United States, 77384
Eye Care Assoc of East Texas Recruiting
Tyler, Texas, United States, 75701
Strategic Clinical Research Group, LLC Active, not recruiting
Willow Park, Texas, United States, 76087
United States, Utah
Retina Associates of Utah Recruiting
Salt Lake City, Utah, United States, 84107
University of Utah; Division of Gastroenterology/Hepatology Recruiting
Salt Lake City, Utah, United States, 84132
United States, Vermont
University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1 Recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Emerson Clinical Research Institute Recruiting
Falls Church, Virginia, United States, 22044
Piedmont Eye Center Recruiting
Lynchburg, Virginia, United States, 24502
Wagner Macula & Retina Center Recruiting
Norfolk, Virginia, United States, 23451
Virginia Retina Center Recruiting
Warrenton, Virginia, United States, 20186
United States, Washington
Spokane Eye Clinical Research Recruiting
Spokane, Washington, United States, 99204
United States, West Virginia
West Virginia University Eye Institute Recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Austria
LKH-Univ.Klinikum Graz; Universitäts-Augenklinik Recruiting
Graz, Austria, 8036
Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde Recruiting
Linz, Austria, 4021
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie Recruiting
Wien, Austria, 1090
Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik Recruiting
Wien, Austria, 1140
Bulgaria
Medical Center for Eye Health - Focus Ltd Recruiting
Sofia, Bulgaria, 1303
Pentagram Eye Hospital (Medical Center "Pentagram") Active, not recruiting
Sofia, Bulgaria, 1309
Spec. Ophth. Hospital for Active Treatment- Academic Pashev Recruiting
Sofia, Bulgaria, 1517
Specialized Hospital for Active Treatment of Eye Diseases Zora Recruiting
Sofia, Bulgaria, 1784
Ambulatory - Medical Center for Specialized Medical Assistance - "Eye Clinic Sveta Petka" Ltd Recruiting
Varna, Bulgaria, 9002
France
Hopital Pellegrin; Ophtalmologie Recruiting
Bordeaux, France, 33000
Pole Vision Val d'Ouest; Ophtalmologie Recruiting
Ecully, France, 69130
Centre Paradis Monticelli; Ophtalmologie Recruiting
Marseille, France, 13008
CHU Nantes - Hôtel Dieu; Ophthalmology Not yet recruiting
Nantes, France, 44093
Fondation Rothschild; Ophtalmologie Recruiting
Paris Cedex 19, France, 75940
Centre Odeon; Exploration Ophtalmologique Recruiting
Paris, France, 75006
Hopital Lariboisiere; Ophtalmologie Recruiting
Paris, France, 75010
Clinique Mathilde; Ophtalmologie Not yet recruiting
Rouen, France, 76175
Cabinet La Maison Rouge; Ophtalmologie Not yet recruiting
Strasbourg, France, 67000
Germany
Uniklinikum RWTH Aachen, Klinik für Augenheilkunde Recruiting
Aachen, Germany, 52074
Charité-Universitätsmedizin Berlin, Campus Benjamin Franklin, Klinik für Augenheilkunde, CC 16 Recruiting
Berlin, Germany, 12203
Universitäts-Augenklinik Bonn Recruiting
Bonn, Germany, 53127
Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde Recruiting
Düsseldorf, Germany, 40225
Universitätsklinikum Essen; Augenklinik Not yet recruiting
Essen, Germany, 45147
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde Recruiting
Göttingen, Germany, 37075
Medizinische Hochschule Hannover, Klinik für Augenheilkunde Recruiting
Hannover, Germany, 30625
Universitätsklinikum Köln; Augenklinik Recruiting
Köln, Germany, 50937
Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde Recruiting
Lübeck, Germany, 23538
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik Recruiting
Mainz, Germany, 55131
Augenabteilung am St. Franziskus-Hospital Recruiting
Münster, Germany, 48145
Universitätsklinikum Münster; Augenheilkunde Recruiting
Münster, Germany, 48149
Augenzentrum Siegburg Recruiting
Siegburg, Germany, 53721
Hungary
Budapest Retina Associates Kft. Active, not recruiting
Budapest, Hungary, 1133
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika Active, not recruiting
Debrecem, Hungary, 4032
Ganglion Medial Center Recruiting
Pecs, Hungary, 7621
Szegedi Tudományegyetem ÁOK; Department of Ophtalmology Recruiting
Szeged, Hungary, 6720
Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET Not yet recruiting
Szombathely, Hungary, 9700
Zala Megyei Kórház; SZEMESZET Recruiting
Zalaegerszeg, Hungary, 8900
Israel
Rambam Medical Center; Opthalmology Recruiting
Haifa, Israel, 3109601
Hadassah MC; Ophtalmology Recruiting
Jerusalem, Israel, 9112001
Rabin MC; Ophtalmology Active, not recruiting
Petach Tikva, Israel, 4941492
Kaplan Medical Center Recruiting
Rehovot, Israel, 7661041
Tel Aviv Sourasky MC; Ophtalmology Recruiting
Tel Aviv, Israel, 6423906
Italy
Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica Recruiting
Chieti, Abruzzo, Italy, 66100
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico Recruiting
Roma, Lazio, Italy, 00198
UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA Active, not recruiting
Genova, Liguria, Italy, 16132
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica Recruiting
Milano, Lombardia, Italy, 20100
Irccs Ospedale San Raffaele;U.O. Oculistica Recruiting
Milano, Lombardia, Italy, 20132
Azienda Ospedaliero Universitaria Di Sassari;U.O. Oculistica Not yet recruiting
Sassari, Sardegna, Italy, 07100
Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica Recruiting
Perugia, Umbria, Italy, 06129
Japan
Chukyo Hospital Recruiting
Aichi, Japan, 457-8510
Sugita Eye Hospital Recruiting
Aichi, Japan, 460-0008
Kamiiida daiichi General hospital Recruiting
Aichi, Japan, 462-0802
Nagoya University Hospital Recruiting
Aichi, Japan, 466-8560
Nagoya City University Hospital Active, not recruiting
Aichi, Japan, 467-8602
Aichi Medical University Hospital Recruiting
Aichi, Japan, 480-1195
Daiyukai Daiichi Hospital Recruiting
Aichi, Japan, 491-8551
Toho University Sakura Medical Center Recruiting
Chiba, Japan, 285-8741
Hayashi Eye Hospital Recruiting
Fukuoka, Japan, 811-3101
Murakami Karindoh Hospital Recruiting
Fukuoka, Japan, 819-8585
Kurume University Hospital Recruiting
Fukuoka, Japan, 830-0011
Fukushima Medical University Hospital Recruiting
Fukushima, Japan, 960-1295
Southern TOHOKU Eye Clinic Recruiting
Fukushima, Japan, 963-8052
Yoshida Eye Hospital Not yet recruiting
Hokkaido, Japan, 041-0851
Sapporo City General Hospital Recruiting
Hokkaido, Japan, 060-8604
Hokkaido University Hospital Not yet recruiting
Hokkaido, Japan, 060-8648
Asahikawa Medical University Hospital Recruiting
Hokkaido, Japan, 078-8510
Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC) Recruiting
Hyogo, Japan, 660-8550
Hyogo College of Medicine Hospital Recruiting
Hyogo, Japan, 663-8501
Kozawa eye hospital and diabetes center Recruiting
Ibaraki, Japan, 310-0845
Kagoshima University Hospital Recruiting
Kagoshima, Japan, 890-8520
St. Marianna University School of Medicine Hospital Recruiting
Kanagawa, Japan, 216-8511
Ideta Eye Hospital Recruiting
Kumamoto, Japan, 860-0027
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Mie University Hospital Recruiting
Mie, Japan, 514-8507
University of Miyazaki Hospital Recruiting
Miyazaki, Japan, 889-1692
Shinshu University Hospital Recruiting
Nagano, Japan, 390-8621
Nara Medical University Hospital Recruiting
Nara, Japan, 634-8522
Kitano Hospital Recruiting
Osaka, Japan, 530-8480
Osaka City University Hospital Not yet recruiting
Osaka, Japan, 545-8586
Kansai Medical University Hospital Recruiting
Osaka, Japan, 573-1191
National Defense Medical College Hospital Not yet recruiting
Saitama, Japan, 359-8513
Shiga University Of Medical Science Hospital Recruiting
Shiga, Japan, 520-2192
Seirei Hamamatsu General Hospital Not yet recruiting
Shizuoka, Japan, 430-8558
Tokushima University Hospital Recruiting
Tokushima, Japan, 770-8503
Nihon University Hospital Recruiting
Tokyo, Japan, 101-8309
Tokyo Women's Medical University Hospital Recruiting
Tokyo, Japan, 162-8666
Kyorin University Hospital Recruiting
Tokyo, Japan, 181-8611
Tokyo Medical University Hachioji Medical Center Active, not recruiting
Tokyo, Japan, 193-0998
Yamaguchi University Hospital Recruiting
Yamaguchi, Japan, 755-8505
University of Fukui Hospital Recruiting
Yoshida-gun, Japan, 910-1193
Mexico
Centro Oftalmológico Mira, S.C Recruiting
Del. Cuauhtemoc, Mexico CITY (federal District), Mexico, 06760
Montemayor y Asociados Not yet recruiting
Monterrey, Nuevo LEON, Mexico, 64060
Macula Retina Consultores Recruiting
Mexico, D.F., Mexico, 01120
Hospital de la Ceguera APEC Recruiting
Mexico, D.F., Mexico, 04030
Instituto Mexicano de Oftalmologia I.A.P. Recruiting
Querétaro, Mexico, 76090
Peru
Mácula D&T Recruiting
Lima, Peru, 27
Oftalmosalud Srl Recruiting
Lima, Peru, 27
TG Laser Oftalmica Recruiting
Lima, Peru, 27
Oftalmolaser Recruiting
Lima, Peru, Lima 33
Centro de Investigación Instituto Regional de Oftalmología; Instituto Regional de Oftalmología Withdrawn
Trujillo, Peru, 13011
Poland
Szpital sw. Lukasza Recruiting
Bielsko-Biała, Poland, 43-309
Szpital Specjalistyczny nr 1; Oddzial Okulistyki Active, not recruiting
Bytom, Poland, 41-902
Dobry Wzrok Sp Z O O Not yet recruiting
Gdańsk, Poland, 80-822
Oko Staniewicz Panasik Trapkowski Spółka Jawna Not yet recruiting
Gdynia, Poland, 81-310
Uniwersyteckie Centrum Kliniczne; UCK im prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego Withdrawn
Katowice, Poland, 40-514
Gabinet Okulistyczny Prof Edward Wylegala Recruiting
Katowice, Poland, 40-594
Centrum Medyczne UNO-MED Active, not recruiting
Krakow, Poland, 31-070
Optomed Sp. z o.o. Recruiting
Rybnik, Poland, 44-203
Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki Recruiting
Rzeszów, Poland, 35-055
Wojskowy Instytut Medyczny Withdrawn
Warszawa, Poland, 04-141
SPEKTRUM Osrodek Okulistyki Klinicznej Recruiting
Wroclaw, Poland, 53-334
Russian Federation
Ufa Institute of Scientific Research of Eye Diseases of Academy of Sciences Withdrawn
UFA, Baskortostan, Russian Federation, 450008
Clinic Optimed Recruiting
UFA, Baskortostan, Russian Federation, 450059
FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences Recruiting
Moscow, Russian Federation, 119435
St. Educ.Inst. of High Prof.Education "Samara State Medical University"; Chair of ophathalmology Not yet recruiting
Samara, Russian Federation, 443068
Medical Military Academy n.a S.M.Kirov Recruiting
St.Petersburg, Russian Federation, 194044
Slovakia
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB Withdrawn
Bratislava, Slovakia, 851 07
Nemocnica s poliklinikou Trebišov, a.s. Recruiting
Trebišov, Slovakia, 075 01
Fakultna nemocnica Trencin Ocna klinika Active, not recruiting
Trencin, Slovakia, 911 71
Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie Recruiting
Zilina, Slovakia, 012 07
Spain
Instituto Clinico Quirurgico de Oftalmologia - ICQO Recruiting
Bilbao, Guipuzcoa, Spain, 48006
Hospital Son Espases Palma de Mallorca; Servicio de oftalmologia Not yet recruiting
Palma De Mallorca, Islas Baleares, Spain, 07120
Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia Recruiting
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital Universitario de Gran Canaria; Servicio de oftalmologia Recruiting
Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
Hospital Universitario Puerta de Hierro; Servicio de oftalmologia Recruiting
Majadahonda, Madrid, Spain, 28222
Clinica Universitaria de Navarra; Servicio de Oftalmologia Recruiting
Pamplona, Navarra, Spain, 31008
Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia Active, not recruiting
Albacete, Spain, 02006
VISSUM Instituto Oftalmológico de Alicante Recruiting
Alicante, Spain, 03016
Centro de Oftalmologia Barraquer; Servicio Oftalmologia Recruiting
Barcelona, Spain, 08021
Hospital Clinic Barcelona; Servicio Oftalmologia Recruiting
Barcelona, Spain, 08036
Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia Recruiting
Barcelona, Spain, 08041
Clinica Universitaria de Navarra; Servicio de Oftalmologia Recruiting
Madrid, Spain, 28027
Hospital Universitario de Valencia; Servicio de Oftalmologia Not yet recruiting
Valencia, Spain, 46014
Hospital Clinico Universitario de Valladolid; Servicio de oftalmologia Recruiting
Valladolid, Spain, 47005
Hospital Universitario Miguel Servet; Servicio de Oftalmologia Recruiting
Zaragoza, Spain, 50009
Turkey
Hacettepe University Medical Faculty; Department of Ophthalmology Recruiting
Ankara, Turkey, 06100
Ankara Numune Training and Research Hospital; Department Of Ophthalmology Not yet recruiting
Ankara, Turkey, 06230
Istanbul University Cerrahpasa Faculty of Medicine Not yet recruiting
Istanbul, Turkey, 34098
Ege University Medical Faculty; Department of Ophthalmology Recruiting
Izmir, Turkey, 35100
Selcuk University Faculty of Medicine; Department Of Ophthalmology Recruiting
Konya, Turkey, 42130
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03622580     History of Changes
Other Study ID Numbers: GR40349
2017-005104-10 ( EudraCT Number )
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases