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 RicoActive - Recruiting
Retinal Consultants of AZ, Ltd
Peoria, Arizona 85381
United StatesActive - Recruiting
Associated Retina Consultants
Phoenix, Arizona 85020
United StatesActive - Recruiting
Retinal Consultants Medical Group
Modesto, California 95356
United StatesActive - Recruiting
Bay Area Retina Associates
Walnut Creek, California 94598
United StatesSite Not Available
Florida Eye Associates
Melbourne, Florida 30394-7344
United StatesActive - Recruiting
Cumberland Valley Retina PC
Hagerstown, Maryland 21740
United StatesActive - Recruiting
Retina Associates of Michigan
Grand Blanc, Michigan 48439-8301
United StatesActive - Recruiting
Ross Eye Institute
Buffalo, New York 14209-2102
United StatesActive - Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio 44106
United StatesActive - Recruiting
Erie Retinal Surgery
Erie, Pennsylvania 16507
United StatesCompleted
Austin Clinical Research LLC
Austin, Texas 78750
United StatesSite Not Available
Retina Consultants of Texas
The Woodlands, Texas 78240
United StatesActive - Recruiting
Spokane Eye Clinical Research
Spokane, Washington 99204-2509
United StatesActive - Recruiting
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