Phase
Condition
Diabetic Retinopathy
Diabetic Macular Edema
Macular Edema
Treatment
Ranibizumab
RO7200220
Sham Procedure
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of diabetes mellitus (Type 1 or Type 2)
Macular thickening secondary to diabetic macular edema (DME) involving the center ofthe macula
Decreased visual acuity attributable primarily to DME
Ability and willingness to provide written informed consent and to comply with thestudy protocol
Willingness to allow Aqueous Humor collection
For women of childbearing potential: agreement to remain abstinent or use at leastone highly effective contraceptive method that results in a failure rate of <1% peryear during the treatment period and for at least 12 weeks after the final dose ofstudy treatment
Exclusion
Exclusion Criteria:
Hemoglobin A1c (HbA1c) of greater than (>) 12%
Uncontrolled blood pressure, defined as a systolic value greater than (>)180millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient isat rest
Currently pregnant or breastfeeding, or intend to become pregnant during the study
Prior treatment with panretinal photocoagulation or macular laser to the study eye
Any intraocular or periocular corticosteroid treatment within the past 16 weeksprior to Day 1 to the study eye
Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye
Prior or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1to the study eye; Vabysmo^TM within 16 weeks prior to Day 1, prior Beovu® is notpermitted
Prior administration of IVT brolucizumab (Beovu®): ever; vamikibart: </=24 weeksprior to Day 1) in either eye
Any proliferative diabetic retinopathy
Active intraocular or periocular infection or active intraocular inflammation in thestudy eye
Any current or history of ocular disease other than DME that may confound assessmentof the macula or affect central vision in the study eye
Any current ocular condition which, in the opinion of the investigator, is currentlycausing or could be expected to contribute to irreversible vision loss due to acause other than DME in the study eye
Other protocol-specified inclusion/exclusion criteria may apply
Study Design
Connect with a study center
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO
ArgentinaSite Not Available
Organizacion Medica de Investigacion
Buenos Aires 3435910, C1015ABO
ArgentinaSite Not Available
Centro Oftalmologico Dr. Charles S.A.
Capital Federal, C1116
ArgentinaSite Not Available
Centro Oftalmológico Dr. Charles S.A.
Capital Federal, C1116
ArgentinaSite Not Available
Oftalmos
Capital Federal, C1120AAN
ArgentinaSite Not Available
Buenos Aires Mácula
Ciudad Autonoma Buenos Aires, C1061AAE
ArgentinaSite Not Available
Centro Privado de Ojos Romagosa
Cordoba,
ArgentinaSite Not Available
Centro Privado de Ojos Romagosa
Córdoba 3860259,
ArgentinaSite Not Available
Centro de ojos Loria
Lomas de Zamora,
ArgentinaSite Not Available
Centro de ojos Loria
Lomas de Zamora 3431271,
ArgentinaSite Not Available
Oftar
Mendoza, M5500GGK
ArgentinaSite Not Available
Oftar
Mendoza 3844421, M5500GGK
ArgentinaSite Not Available
Grupo Laser Vision
Rosario, S2000DLA
ArgentinaSite Not Available
Microcirugía Ocular S.A
Rosario, S2000CTC
ArgentinaSite Not Available
Grupo Laser Vision
Rosario 3838583, S2000DLA
ArgentinaSite Not Available
Microcirugía Ocular S.A
Rosario 3838583, S2000CTC
ArgentinaSite Not Available
Organizacion Medica de Investigacion
San Nicolás, C1015ABO
ArgentinaSite Not Available
Retina Institute of Ottawa
Ottawa, Ontario K2B 7E9
CanadaSite Not Available
The Retina Centre of Ottawa
Ottawa, Ontario K2B 7E9
CanadaSite Not Available
Toronto Retina Institute
Toronto, Ontario M3C 0G9
CanadaSite Not Available
Retina Institute of Ottawa
Ottawa 6094817, Ontario 6093943 K2B 7E9
CanadaSite Not Available
Toronto Retina Institute
Toronto 6167865, Ontario 6093943 M3C 0G9
CanadaSite Not Available
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec J7H 0E8
CanadaSite Not Available
Institut De L'Oeil Des Laurentides
Boisbriand 5905132, Quebec 6115047 J7H 0E8
CanadaSite Not Available
Faculty Hospital Ostrava
Ostrava, 708 52
CzechiaSite Not Available
Faculty Hospital Ostrava; Ophthalmology clinic
Ostrava, 708 52
CzechiaSite Not Available
Faculty Hospital Ostrava
Ostrava 3068799, 708 52
CzechiaSite Not Available
AXON Clinical
Prague,
CzechiaSite Not Available
Faculty Hospital Kralovske Vinohrady
Prague, 100 34
CzechiaSite Not Available
Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
Prague, 100 34
CzechiaSite Not Available
General Teaching Hospital Prague
Prague, 128 08
CzechiaSite Not Available
General Teaching Hospital Prague; Ophthalmology clinic
Prague, 128 08
CzechiaSite Not Available
AXON Clinical
Prague 3067696,
CzechiaSite Not Available
Faculty Hospital Kralovske Vinohrady
Prague 3067696, 100 34
CzechiaSite Not Available
General Teaching Hospital Prague
Prague 3067696, 128 08
CzechiaSite Not Available
Pusan National University Hospital
Busan, 602-739
Korea, Republic ofSite Not Available
Yeungnam University Medical Center
Daegu, 42415
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, 13605
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Kim's Eye Hospital
Seoul, 07301
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 135-710
Korea, Republic ofSite Not Available
Centrum Medyczne Julianow
?ód?, 91-321
PolandSite Not Available
Dobry Wzrok Sp Z O O
Gda?sk, 80-402
PolandSite Not Available
Dobry Wzrok Sp Z O O
Gdańsk, 80-402
PolandSite Not Available
Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
Gliwice, 44-100
PolandSite Not Available
Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
Gliwice, 44-100
PolandSite Not Available
Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
Gliwice 3099230, 44-100
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne
Katowice, 40-514
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne; UCK im prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
Katowice, 40-514
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne
Katowice 3096472, 40-514
PolandSite Not Available
Centrum Medyczne UNO-MED
Krakow, 31-070
PolandSite Not Available
Centrum Medyczne UNO-MED
Krakow 3094802, 31-070
PolandSite Not Available
SPSK nr 1 w Lublinie
Lublin, 20-079
PolandSite Not Available
SPSK nr 1 w Lublinie; Klinika Chirurgii Siatkowki i Ciala Szklistego
Lublin, 20-079
PolandSite Not Available
SPSK nr 1 w Lublinie
Lublin 765876, 20-079
PolandSite Not Available
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, 10-424
PolandSite Not Available
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn 763166, 10-424
PolandSite Not Available
LensClinic
Rybnik, 44-203
PolandSite Not Available
LensClinic
Rybnik 3086586, 44-203
PolandSite Not Available
Caminomed
Tarnowskie Góry, 42-600
PolandSite Not Available
Caminomed
Tarnowskie Góry 3083440, 42-600
PolandSite Not Available
Centrum Medyczne Julianow
Łódź, 91-321
PolandSite Not Available
Emanuelli Research and Development Center LLC
Arecibo, 00612
Puerto RicoSite Not Available
Emanuelli Research and Development Center LLC
Arecibo 4562635, 00612
Puerto RicoSite Not Available
Yeungnam University Medical Center
Daegu 1835329, 42415
South KoreaSite Not Available
Seoul National University Bundang Hospital
Seongnam-si 1897000, 13605
South KoreaSite Not Available
Asan Medical Center
Seoul 1835848, 05505
South KoreaSite Not Available
Kim's Eye Hospital
Seoul 1835848, 07301
South KoreaSite Not Available
Samsung Medical Center
Seoul 1835848, 06351
South KoreaSite Not Available
Hospital General de Catalunya; Servicio de oftalmologia
Sant Cugat De Valles, Barcelona 08190
SpainSite Not Available
Hospital General de Catalunya
Sant Cugat de Valles, Barcelona 08190
SpainSite Not Available
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid 28222
SpainSite Not Available
Hospital Universitario Puerta de Hierro; Servicio de oftalmologia
Majadahonda, Madrid 28222
SpainSite Not Available
Hospital Universitario Puerta de Hierro
Majadahonda 3117667, Madrid 3117732 28222
SpainSite Not Available
Oftalvist Valencia
Burjassot, Valencia 46100
SpainSite Not Available
Oftalvist Valencia
Burjassot 2520712, Valencia 2593113 46100
SpainSite Not Available
Hospital Clinico San Carlos; Servicio de oftalmologia
Madrid, 28040
SpainSite Not Available
Hospital Universitario Miguel Servet
Zaragoza, 50009
SpainSite Not Available
Hospital Universitario Miguel Servet; Servicio de Oftalmologia
Zaragoza, 50009
SpainSite Not Available
Hospital Universitario Miguel Servet
Zaragoza 3104324, 50009
SpainSite Not Available
Bradford Royal Infirmary
Bradford, BD9 6RJ
United KingdomSite Not Available
Bristol Eye Hospital
Bristol, BS1 2LX
United KingdomSite Not Available
Bristol Eye Hospital
Bristol 2654675, BS1 2LX
United KingdomSite Not Available
Gloucestershire Hospitals NHS Foundation Trust
Gloucestershire, GL1 3NN
United KingdomSite Not Available
Royal Surrey County Hospital
Guildford, GU2 7XX
United KingdomSite Not Available
Royal Surrey County Hospital
Guildford 2647793, GU2 7XX
United KingdomSite Not Available
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
United KingdomSite Not Available
Moorfields Eye Hospital NHS Foundation Trust
London 2643743, EC1V 2PD
United KingdomSite Not Available
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
United KingdomSite Not Available
Royal Victoria Infirmary
Newcastle upon Tyne 2641673, NE1 4LP
United KingdomSite Not Available
Win Retina
Arcadia, California 91006
United StatesSite Not Available
Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
United StatesSite Not Available
Retina Consultants, San Diego
Poway, California 92064
United StatesSite Not Available
Retinal Consultants Med Group
Sacramento, California 95825
United StatesSite Not Available
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California 90502
United StatesSite Not Available
Bay Area Retina Associates
Walnut Creek, California 94598
United StatesSite Not Available
Win Retina
Arcadia 5324477, California 5332921 91006
United StatesSite Not Available
Retina Consultants, San Diego
Poway 5384690, California 5332921 92064
United StatesSite Not Available
Retinal Consultants Med Group
Sacramento 5389489, California 5332921 95825
United StatesSite Not Available
Bay Area Retina Associates
Walnut Creek 5406990, California 5332921 94598
United StatesSite Not Available
Colorado Retina Associates, PC
Lakewood, Colorado 80228
United StatesSite Not Available
Colorado Retina Associates, PC
Lakewood 5427946, Colorado 5417618 80228
United StatesSite Not Available
Emerson Clinical Research Institute LLC
Washington, District of Columbia 20011-3010
United StatesSite Not Available
Emerson Clinical Research Institute LLC
Washington D.C. 4140963, District of Columbia 4138106 20011-3010
United StatesSite Not Available
Rand Eye
Deerfield Beach, Florida 33064
United StatesSite Not Available
Pinnacle Research Institute
Fort Lauderdale, Florida 33309
United StatesSite Not Available
National Ophthalmic Research Institute
Fort Myers, Florida 33912
United StatesSite Not Available
Retina Macula Specialists of Miami - LeJeune Road Office
Miami, Florida 33126-5690
United StatesSite Not Available
Florida Retina Institute
Orlando, Florida 32806-1101
United StatesSite Not Available
Retina Vitreous Associates of Florida
Saint Petersburg, Florida 33711-1141
United StatesSite Not Available
Retina Specialists of Tampa
Wesley Chapel, Florida 33544
United StatesSite Not Available
Rand Eye
Deerfield Beach 4153071, Florida 4155751 33064
United StatesSite Not Available
National Ophthalmic Research Institute
Fort Myers 4155995, Florida 4155751 33912
United StatesSite Not Available
Florida Retina Institute
Orlando 4167147, Florida 4155751 32806-1101
United StatesSite Not Available
Retina Vitreous Associates of Florida
St. Petersburg 4171563, Florida 4155751 33607
United StatesSite Not Available
Retina Specialists of Tampa
Wesley Chapel 4177727, Florida 4155751 33544
United StatesSite Not Available
Butchertown Clinical Trials
Louisville, Kentucky 40206
United StatesSite Not Available
Butchertown Clinical Trials
Louisville 4299276, Kentucky 6254925 40206
United StatesSite Not Available
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
United StatesSite Not Available
Cumberland Valley Retina PC
Hagerstown, Maryland 21740
United StatesSite Not Available
Cumberland Valley Retina PC
Hagerstown 4357141, Maryland 4361885 21740
United StatesSite Not Available
Tallman Eye Associates
Lawrence, Massachusetts 01843
United StatesSite Not Available
Deep Blue Retina PLLC
Southaven, Mississippi 38671
United StatesSite Not Available
Deep Blue Retina PLLC
Southaven 4446675, Mississippi 4436296 38671
United StatesSite Not Available
Sierra Eye Associates
Reno, Nevada 89502
United StatesSite Not Available
Sierra Eye Associates
Reno 5511077, Nevada 5509151 89502
United StatesSite Not Available
Opthalmic Consultants of LI
Lynbrook, New York 11563
United StatesSite Not Available
Buffalo Niagara Retina Associates
Orchard Park, New York 14127
United StatesSite Not Available
Retina Associates of Western New York
Rochester, New York 14620
United StatesSite Not Available
University of Rochester Flaum Eye Institute
Rochester, New York 14642
United StatesSite Not Available
Opthalmic Consultants of LI
Lynbrook 5125523, New York 5128638 11563
United StatesSite Not Available
University of Rochester Flaum Eye Institute
Rochester 5134086, New York 5128638 14642
United StatesSite Not Available
Western Carolina Retinal Associate PA
Asheville, North Carolina 28803
United StatesSite Not Available
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Western Carolina Retinal Associate PA
Asheville 4453066, North Carolina 4482348 28803
United StatesSite Not Available
Wake Forest Baptist Medical Center
Winston-Salem 4499612, North Carolina 4482348 27157
United StatesSite Not Available
Meridian Clinical Research
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44915
United StatesSite Not Available
Meridian Clinical Research
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
Verum Research LLC
Eugene, Oregon 97401
United StatesSite Not Available
EyeHealth Northwest
Portland, Oregon 97225
United StatesSite Not Available
Verum Research LLC
Eugene 5725846, Oregon 5744337 97401
United StatesSite Not Available
EyeHealth Northwest
Portland 5746545, Oregon 5744337 97225
United StatesSite Not Available
Erie Retinal Surgery
Erie, Pennsylvania 16507
United StatesSite Not Available
Eye Care Specialists, PC
Kingston, Pennsylvania 18704
United StatesSite Not Available
Sewickley Eye Group
Sewickley, Pennsylvania 15143
United StatesSite Not Available
Erie Retinal Surgery
Erie 5188843, Pennsylvania 6254927 16507
United StatesSite Not Available
Eye Care Specialists, PC
Kingston 5196245, Pennsylvania 6254927 18704
United StatesSite Not Available
Sewickley Eye Group
Sewickley 5211506, Pennsylvania 6254927 15143
United StatesSite Not Available
Charleston Neuroscience Institute
Ladson, South Carolina 29456
United StatesSite Not Available
Charleston Neuroscience Institute
Ladson 4584277, South Carolina 4597040 29456
United StatesSite Not Available
Black Hills Eye Institute
Rapid City, South Dakota 57701
United StatesSite Not Available
Black Hills Eye Institute
Rapid City 5768233, South Dakota 5769223 57701
United StatesSite Not Available
Retina Consultants of Nashville
Nashville, Tennessee 37203
United StatesSite Not Available
Retina Consultants of Nashville
Nashville 4644585, Tennessee 4662168 37203
United StatesSite Not Available
Texas Retina Associates
Arlington, Texas 76012
United StatesSite Not Available
Austin Clinical Research LLC
Austin, Texas 78750
United StatesSite Not Available
Retina Consultants of Texas
Bellaire, Texas 77401
United StatesSite Not Available
Valley Retina Institute P.A.
Harlingen, Texas 78550
United StatesSite Not Available
Valley Retina Institute P.A.
McAllen, Texas 78503
United StatesSite Not Available
Medical Center Ophthalmology Associates
San Antonio, Texas 78240
United StatesSite Not Available
Retina Consultants of Texas
The Woodlands, Texas 78240
United StatesSite Not Available
Strategic Clinical Research Group, LLC
Willow Park, Texas 76087
United StatesSite Not Available
Texas Retina Associates
Arlington 4671240, Texas 4736286 75075
United StatesSite Not Available
Austin Clinical Research LLC
Austin 4671654, Texas 4736286 78750
United StatesSite Not Available
Retina Consultants of Texas
Bellaire 4673353, Texas 4736286 77401
United StatesSite Not Available
Valley Retina Institute P.A.
McAllen 4709796, Texas 4736286 78503
United StatesSite Not Available
Retina Consultants of Texas
The Woodlands 4736476, Texas 4736286 78240
United StatesSite Not Available
Strategic Clinical Research Group, LLC
Willow Park 4742296, Texas 4736286 76087
United StatesSite Not Available
Piedmont Eye Center
Lynchburg, Virginia 24502
United StatesSite Not Available
Wagner Kapoor Institute
Norfolk, Virginia 23502
United StatesSite Not Available
Wagner Macula & Retina Center
Norfolk, Virginia 23502
United StatesSite Not Available
Piedmont Eye Center
Lynchburg 4771075, Virginia 6254928 24502
United StatesSite Not Available
Wagner Macula & Retina Center
Norfolk 4776222, Virginia 6254928 23502
United StatesSite Not Available

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