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

Last updated: May 15, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - 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: 176
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

    Active - Recruiting

  • Retinal Consultants of AZ, Ltd

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group

    Modesto, California 95356
    United States

    Active - Recruiting

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Florida Eye Associates

    Melbourne, Florida 30394-7344
    United States

    Active - Recruiting

  • Cumberland Valley Retina PC

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Retina Associates of Michigan

    Grand Blanc, Michigan 48439-8301
    United States

    Active - Recruiting

  • Ross Eye Institute

    Buffalo, New York 14209-2102
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Erie Retinal Surgery

    Erie, Pennsylvania 16507
    United States

    Completed

  • Austin Clinical Research LLC

    Austin, Texas 78750
    United States

    Site Not Available

  • Retina Consultants of Texas

    The Woodlands, Texas 78240
    United States

    Active - Recruiting

  • Spokane Eye Clinical Research

    Spokane, Washington 99204-2509
    United States

    Active - Recruiting

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