A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)

Last updated: January 9, 2026
Sponsor: Genentech, Inc.
Overall Status: Active - Not Recruiting

Phase

1

Condition

Diabetic Macular Edema

Macular Edema

Diabetic Retinopathy

Treatment

RO7497372

Clinical Study ID

NCT06847854
BP44175
  • Ages > 18
  • All Genders

Study Summary

This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending doses of RO7497372 after unilateral intravitreal (IVT) administration in participants with DME. The main purpose of Part 1 is to provide data for RO7497372 safety and tolerability, as well as to characterize the ocular and systemic pharmacokinetics (PK), systemic anti-drug antibodies (ADA), and duration of target engagement, i.e., the pharmacodynamics (PD) in aqueous humor (AH) and blood. Part 2 will evaluate the safety, tolerability, PK, and PD of two dose strengths of RO7497372 (low dose and high dose), identified as safe and tolerated in Part 1.

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

Total Participants: 151
Treatment Group(s): 1
Primary Treatment: RO7497372
Phase: 1
Study Start date:
December 08, 2022
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Emanuelli Research and Development Center

    Arecibo, 00612
    Puerto Rico

    Site Not Available

  • Emanuelli Research and Development Center

    Arecibo 4562635, 00612
    Puerto Rico

    Site Not Available

  • Retinal Consultants of AZ, Ltd

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Barnet Dulaney Perkins Eye Center

    Mesa 5304391, Arizona 5551752 85206
    United States

    Site Not Available

  • Retinal Consultants of AZ, Ltd

    Peoria 5308480, Arizona 5551752 85381
    United States

    Site Not Available

  • Associated Retina Consultants

    Phoenix 5308655, Arizona 5551752 85020
    United States

    Site Not Available

  • Arkansas Retina Research

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • Global Research Management

    Glendale, California 91204
    United States

    Site Not Available

  • Retinal Consultants Medical Group

    Modesto, California 95356
    United States

    Site Not Available

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Global Research Management

    Glendale 5352423, California 5332921 91204
    United States

    Site Not Available

  • Retinal Consultants Medical Group

    Modesto 5373900, California 5332921 95356
    United States

    Site Not Available

  • Bay Area Retina Associates

    Walnut Creek 5406990, California 5332921 94598
    United States

    Site Not Available

  • Florida Eye Associates

    Melbourne, Florida 30394-7344
    United States

    Site Not Available

  • Medeye Associates

    Miami, Florida 33143
    United States

    Site Not Available

  • Retina Specialists of Tampa

    Wesley Chapel, Florida 33544
    United States

    Site Not Available

  • Center for Retina and Macula Disease

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Florida Eye Associates

    Melbourne 4163971, Florida 4155751 32901
    United States

    Site Not Available

  • Medeye Associates

    Miami 4164138, Florida 4155751 33143
    United States

    Site Not Available

  • East Florida Eye Institute

    Stuart 4174201, Florida 4155751 34994
    United States

    Site Not Available

  • Retina Specialists of Tampa

    Wesley Chapel 4177727, Florida 4155751 33544
    United States

    Site Not Available

  • Center for Retina and Macula Disease

    Winter Haven 4178552, Florida 4155751 33880
    United States

    Site Not Available

  • Cumberland Valley Retina PC

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Cumberland Valley Retina PC

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Site Not Available

  • Retina Associates of Michigan

    Grand Blanc, Michigan 48439-8301
    United States

    Site Not Available

  • Retina Associates of Michigan

    Grand Blanc 4994320, Michigan 5001836 48439-8301
    United States

    Site Not Available

  • Foundation for Vision Research

    Grand Rapids 4994358, Michigan 5001836 49546
    United States

    Site Not Available

  • Retina Consultants Minnesota

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Retina Consultants Minnesota

    Saint Louis Park 5045021, Minnesota 5037779 55416
    United States

    Site Not Available

  • Mississippi Retina Associates

    Madison, Mississippi 39202
    United States

    Site Not Available

  • Mississippi Retina Associates

    Madison 4434663, Mississippi 4436296 39202
    United States

    Site Not Available

  • The Retina Institute

    St Louis 4407066, Missouri 4398678 63128
    United States

    Site Not Available

  • Sierra Eye Associates

    Reno 5511077, Nevada 5509151 89502
    United States

    Site Not Available

  • Ross Eye Institute

    Buffalo, New York 14209-2102
    United States

    Site Not Available

  • Ross Eye Institute

    Buffalo 5110629, New York 5128638 14209-2102
    United States

    Site Not Available

  • Retina Associates of NY

    New York 5128581, New York 5128638 10075
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Site Not Available

  • Verum Research LLC

    Eugene, Oregon 97401
    United States

    Site Not Available

  • EyeHealth Northwest

    Portland, Oregon 97225
    United States

    Site Not Available

  • Verum Research LLC

    Eugene 5725846, Oregon 5744337 97401
    United States

    Site Not Available

  • EyeHealth Northwest

    Portland 5746545, Oregon 5744337 97225
    United States

    Site Not Available

  • Erie Retinal Surgery

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Erie Retinal Surgery

    Erie 5188843, Pennsylvania 6254927 16507
    United States

    Site Not Available

  • Mid Atlantic Retina

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Carolina Eyecare Physicians

    Mt. Pleasant 4588165, South Carolina 4597040 29464
    United States

    Site Not Available

  • Charles Retina Institute

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Site Not Available

  • Austin Clinical Research LLC

    Austin, Texas 78750
    United States

    Site Not Available

  • Brown Retina Institute

    Schertz, Texas 78154
    United States

    Site Not Available

  • Retina Consultants of Texas

    The Woodlands, Texas 78240
    United States

    Site Not Available

  • Austin Clinical Research LLC

    Austin 4671654, Texas 4736286 78750
    United States

    Site Not Available

  • Brown Retina Institute

    Schertz 4727326, Texas 4736286 78154
    United States

    Site Not Available

  • Retina Consultants of Texas

    The Woodlands 4736476, Texas 4736286 78240
    United States

    Site Not Available

  • Salt Lake Retina

    West Jordan 5784549, Utah 5549030 84088
    United States

    Site Not Available

  • Emerson Clinical Research Institute

    Falls Church, Virginia 78503
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • Retina Group of Washington

    Fairfax 4758023, Virginia 6254928 20815
    United States

    Site Not Available

  • Emerson Clinical Research Institute

    Falls Church 4758390, Virginia 6254928 78503
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg 4771075, Virginia 6254928 24502
    United States

    Site Not Available

  • Wagner Kapoor Institute

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Site Not Available

  • Spokane Eye Clinical Research

    Spokane, Washington 99204-2509
    United States

    Site Not Available

  • Spokane Eye Clinical Research

    Spokane 5811696, Washington 5815135 99204-2509
    United States

    Site Not Available

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