A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema

Last updated: June 13, 2025
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Diabetic Macular Edema

Diabetic Retinopathy

Macular Edema

Treatment

Faricimab

RO7446603

Aflibercept

Clinical Study ID

NCT06850922
GR43828
ISRCTN14152148
  • Ages > 18
  • All Genders

Study Summary

This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented diagnosis of diabetes mellitus (DM) (Type 1 or Type 2) with glycatedhemoglobin (HbA1c) < 12%

  • Macular thickening secondary to DME involving the center of the fovea > 325 microns

  • Decreased VA attributable primarily to DME between 25 and 73 ETDRS letters

Exclusion

Exclusion Criteria:

  • Currently untreated DM or previously untreated participants who initiated oralanti-diabetic medication or insulin within 90 days prior to Day 1

  • Uncontrolled blood pressure (BP)

  • Pregnancy or breastfeeding, or intention to become pregnant during the study

  • For Parts 1-4: IVT anti-VEGF treatment within 90 days prior to Day 1; For Part 5:IVT anti-VEGF treatment within 120 days prior to Day 1 or IVT anti-VEGF treatmentprior to Day 1 for treatment naïve participants

  • Treatment with SUSVIMOTM (ranibizumab injection) prior to Day 1

  • Any IVT or periocular (sub-tenons) corticosteroid treatment within 6 months prior toDay 1

  • Any current or history of ocular disease other than DME that may confound assessmentof the macula or affect central vision

  • Proliferative diabetic retinopathy (PDR) in the study eye

  • Active or history of uveitis, vitritis (grade trace or above), and/or scleritis ineither eye Other protocol-specified inclusion/exclusion criteria may apply

Study Design

Total Participants: 546
Treatment Group(s): 3
Primary Treatment: Faricimab
Phase: 1/2
Study Start date:
June 22, 2022
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Shanghai General Hospital - North Campus

    Shanghai, 200080
    China

    Active - Recruiting

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612
    Puerto Rico

    Active - Recruiting

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona 85020-5917
    United States

    Active - Recruiting

  • Associated Retinal Consultants PC

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Barnet Dulaney Perkins Eye Center

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Retinal Consultants of Arizona

    Phoenix, Arizona 85053
    United States

    Active - Recruiting

  • Retinal Research Institute, LLC

    Phoenix, Arizona 85053
    United States

    Active - Recruiting

  • Retinal Diagnostic Center

    Campbell, California 95008
    United States

    Active - Recruiting

  • The Retina Partners

    Encino, California 91436
    United States

    Site Not Available

  • Retina Consultants of Orange County

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group

    Modesto, California 95356-9412
    United States

    Active - Recruiting

  • Northern California Retina-Vitreous Associates

    Mountain View, California 94040
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group

    Sacramento, California 95825
    United States

    Active - Recruiting

  • Macula Retina Vitreous Research Institute

    Torrance, California 90503-3270
    United States

    Active - Recruiting

  • Retina Specialists of Colorado

    Aurora, Colorado 80012
    United States

    Site Not Available

  • Retina Consultants of Southern Colorado PC

    Colorado Springs, Colorado 80909
    United States

    Active - Recruiting

  • Retina Specialists of Colorado

    Denver, Colorado 80222
    United States

    Active - Recruiting

  • Advanced Vision Research Institute

    Longmont, Colorado 80503-6499
    United States

    Active - Recruiting

  • Retina Group of New England

    Waterford, Connecticut 06385-1215
    United States

    Active - Recruiting

  • Blue Ocean Clinical Research

    Clearwater, Florida 33761-2046
    United States

    Active - Recruiting

  • National Ophthalmic Research Institute

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Florida Retina Institute

    Jacksonville, Florida 32216-6347
    United States

    Active - Recruiting

  • Retina Associates of Florida;Retina Associates of Florida

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Southeast Retina Center

    Augusta, Georgia 30909-6440
    United States

    Active - Recruiting

  • Georgia Retina PC

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • University Retina and Macula Associates, PC

    Lemont, Illinois 60439
    United States

    Active - Recruiting

  • Raj K. Maturi, MD PC

    Indianapolis, Indiana 46290
    United States

    Completed

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • The Retina Care Center

    Baltimore, Maryland 21209
    United States

    Active - Recruiting

  • Retina Group of Washington

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Long Island Vitreoretinal Consultants;Opthalmology

    Hauppauge, New York 11788
    United States

    Active - Recruiting

  • Retina Vitreous Surgeons of CNY PC

    Liverpool, New York 13088
    United States

    Active - Recruiting

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Graystone Eye

    Hickory, North Carolina 28602
    United States

    Active - Recruiting

  • Piedmont Retina Specialists

    Winston-Salem, North Carolina 27103-6970
    United States

    Active - Recruiting

  • Cincinnati Eye Institute

    Blue Ash, Ohio 45242-5537
    United States

    Active - Recruiting

  • Ohio State Eye and Ear Institute

    Columbus, Ohio 43212
    United States

    Active - Recruiting

  • Tulsa Retina Consultants

    Tulsa, Oklahoma 74114
    United States

    Active - Recruiting

  • Cascade Medical Research Institute LLC

    Springfield, Oregon 97477
    United States

    Active - Recruiting

  • Erie Retina Research

    Erie, Pennsylvania 16507-1429
    United States

    Active - Recruiting

  • Sewickely Eye Group

    Sewickley, Pennsylvania 15143
    United States

    Active - Recruiting

  • Palmetto Retina Center

    West Columbia, South Carolina 29169-2429
    United States

    Active - Recruiting

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Texas Retina Associates

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Austin Clinical Research LLC

    Austin, Texas 78750
    United States

    Active - Recruiting

  • Austin Retina Associates

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Retina & Vitreous of Texas

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Valley Retina Institute P.A.

    McAllen, Texas 78550-9207
    United States

    Active - Recruiting

  • Brown Retina Institute

    San Antonio, Texas 78251-4551
    United States

    Active - Recruiting

  • Medical Center Ophthalmology Associates

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Consultants of Texas - San Antonio

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas 76087
    United States

    Active - Recruiting

  • Retina Associates of Utah, PLLC;Clinical Research

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Piedmont Eye Center

    Lynchburg, Virginia 24502-4271
    United States

    Active - Recruiting

  • Wagner Kapoor Institute

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Retina Institute of Virginia

    Richmond, Virginia 23235-1962
    United States

    Active - Recruiting

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Active - Recruiting

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