Phase
Condition
Diabetic Macular Edema
Macular Edema
Diabetic Retinopathy
Treatment
RO7497372
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the world healthorganization (WHO) and/or American Diabetes Association
Participant consents to AH collection
Collection of > 90 microlitres (µL) AH (at each visit required per schedule ofactivities [SoA]) if deemed feasible and safe by the Investigator.
Macular thickening secondary to DME involving the center of the fovea with CST >= 325 µm at screening
Decreased BCVA primarily due to DME with ETDRS score of 78 to 19 letters (bothinclusive) at screening
Adequately clear ocular media and adequate pupillary dilation to allow acquisitionof good quality retinal images
Diagnosis of non-proliferative DR
Treatment-naive and Pre-treated participants after washout
Exclusion
Exclusion Criteria:
Any major illness or major surgical procedure ≤ 4 weeks before Day 1
Any febrile illness and associated sequelae ≤ 1 week prior to Day 1
Active cancer ≤ 1 year prior to Day 1
Cerebral vascular accident (including stroke and transient ischemic attack) ormyocardial infarction ≤ 24 weeks prior to Day 1
HbA1c ≥ 12% at screening
Any panretinal photocoagulation or macular laser photocoagulation treatment prior toDay 1
History of vitreoretinal surgery/pars plana vitrectomy
Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery duringthe study
History of any glaucoma surgery including laser glaucoma procedures
Uncontrolled glaucoma
Any active intra- or periocular infection on Day 1
Any active or history of Intraocular inflammation
Intravitreal treatment with an anti-IL-6 (e.g., vamikibart) or anti-IL-6 receptortreatment at any time
Any proliferative DR
Study Design
Connect with a study center
Emanuelli Research and Development Center
Arecibo, 00612
Puerto RicoSite Not Available
Emanuelli Research and Development Center
Arecibo 4562635, 00612
Puerto RicoSite Not Available
Retinal Consultants of AZ, Ltd
Peoria, Arizona 85381
United StatesSite Not Available
Associated Retina Consultants
Phoenix, Arizona 85020
United StatesSite Not Available
Barnet Dulaney Perkins Eye Center
Mesa 5304391, Arizona 5551752 85206
United StatesSite Not Available
Retinal Consultants of AZ, Ltd
Peoria 5308480, Arizona 5551752 85381
United StatesSite Not Available
Associated Retina Consultants
Phoenix 5308655, Arizona 5551752 85020
United StatesSite Not Available
Arkansas Retina Research
Little Rock 4119403, Arkansas 4099753 72205
United StatesSite Not Available
Global Research Management
Glendale, California 91204
United StatesSite Not Available
Retinal Consultants Medical Group
Modesto, California 95356
United StatesSite Not Available
Bay Area Retina Associates
Walnut Creek, California 94598
United StatesSite Not Available
Global Research Management
Glendale 5352423, California 5332921 91204
United StatesSite Not Available
Retinal Consultants Medical Group
Modesto 5373900, California 5332921 95356
United StatesSite Not Available
Bay Area Retina Associates
Walnut Creek 5406990, California 5332921 94598
United StatesSite Not Available
Florida Eye Associates
Melbourne, Florida 30394-7344
United StatesSite Not Available
Medeye Associates
Miami, Florida 33143
United StatesSite Not Available
Retina Specialists of Tampa
Wesley Chapel, Florida 33544
United StatesSite Not Available
Center for Retina and Macula Disease
Winter Haven, Florida 33880
United StatesSite Not Available
Florida Eye Associates
Melbourne 4163971, Florida 4155751 32901
United StatesSite Not Available
Medeye Associates
Miami 4164138, Florida 4155751 33143
United StatesSite Not Available
East Florida Eye Institute
Stuart 4174201, Florida 4155751 34994
United StatesSite Not Available
Retina Specialists of Tampa
Wesley Chapel 4177727, Florida 4155751 33544
United StatesSite Not Available
Center for Retina and Macula Disease
Winter Haven 4178552, Florida 4155751 33880
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
Retina Associates of Michigan
Grand Blanc, Michigan 48439-8301
United StatesSite Not Available
Retina Associates of Michigan
Grand Blanc 4994320, Michigan 5001836 48439-8301
United StatesSite Not Available
Foundation for Vision Research
Grand Rapids 4994358, Michigan 5001836 49546
United StatesSite Not Available
Retina Consultants Minnesota
Saint Louis Park, Minnesota 55416
United StatesSite Not Available
Retina Consultants Minnesota
Saint Louis Park 5045021, Minnesota 5037779 55416
United StatesSite Not Available
Mississippi Retina Associates
Madison, Mississippi 39202
United StatesSite Not Available
Mississippi Retina Associates
Madison 4434663, Mississippi 4436296 39202
United StatesSite Not Available
The Retina Institute
St Louis 4407066, Missouri 4398678 63128
United StatesSite Not Available
Sierra Eye Associates
Reno 5511077, Nevada 5509151 89502
United StatesSite Not Available
Ross Eye Institute
Buffalo, New York 14209-2102
United StatesSite Not Available
Ross Eye Institute
Buffalo 5110629, New York 5128638 14209-2102
United StatesSite Not Available
Retina Associates of NY
New York 5128581, New York 5128638 10075
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland, Ohio 44106
United StatesSite Not Available
Cleveland Clinic Foundation
Cleveland 5150529, Ohio 5165418 44106
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
Mid Atlantic Retina
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Erie Retinal Surgery
Erie 5188843, Pennsylvania 6254927 16507
United StatesSite Not Available
Mid Atlantic Retina
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
Carolina Eyecare Physicians
Mt. Pleasant 4588165, South Carolina 4597040 29464
United StatesSite Not Available
Charles Retina Institute
Germantown 4624601, Tennessee 4662168 38138
United StatesSite Not Available
Austin Clinical Research LLC
Austin, Texas 78750
United StatesSite Not Available
Brown Retina Institute
Schertz, Texas 78154
United StatesSite Not Available
Retina Consultants of Texas
The Woodlands, Texas 78240
United StatesSite Not Available
Austin Clinical Research LLC
Austin 4671654, Texas 4736286 78750
United StatesSite Not Available
Brown Retina Institute
Schertz 4727326, Texas 4736286 78154
United StatesSite Not Available
Retina Consultants of Texas
The Woodlands 4736476, Texas 4736286 78240
United StatesSite Not Available
Salt Lake Retina
West Jordan 5784549, Utah 5549030 84088
United StatesSite Not Available
Emerson Clinical Research Institute
Falls Church, Virginia 78503
United StatesSite Not Available
Piedmont Eye Center
Lynchburg, Virginia 24502
United StatesSite Not Available
Retina Group of Washington
Fairfax 4758023, Virginia 6254928 20815
United StatesSite Not Available
Emerson Clinical Research Institute
Falls Church 4758390, Virginia 6254928 78503
United StatesSite Not Available
Piedmont Eye Center
Lynchburg 4771075, Virginia 6254928 24502
United StatesSite Not Available
Wagner Kapoor Institute
Norfolk 4776222, Virginia 6254928 23502
United StatesSite Not Available
Spokane Eye Clinical Research
Spokane, Washington 99204-2509
United StatesSite Not Available
Spokane Eye Clinical Research
Spokane 5811696, Washington 5815135 99204-2509
United StatesSite Not Available

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