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: March 27, 2026
Sponsor: Genentech, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Macular Edema

Diabetic Retinopathy

Diabetic 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

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality 100730
    China

    Active - Recruiting

  • Beijing Tongren Hospital, Capital Medical University

    Beijing 1816670, Beijing Municipality 2038349 100730
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin Municipality 300384
    China

    Active - Recruiting

  • Tianjin Medical University Eye Hospital

    Tianjin 1792947, Tianjin Municipality 1792943 300384
    China

    Site Not Available

  • Eye Hospital,WMU(Zhejiang Eye Hospital)

    Wenzhou, Zhejiang 325027
    China

    Active - Recruiting

  • Eye Hospital,WMU(Zhejiang Eye Hospital)

    Wenzhou 1791388, Zhejiang 1784764 325027
    China

    Site Not Available

  • Beijing Hospital

    Beijing, 100730
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, 100730
    China

    Active - Recruiting

  • Beijing Hospital

    Beijing 1816670, 100730
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing 1816670, 100730
    China

    Active - Recruiting

  • Shanghai General Hospital - North Campus

    Shanghai, 200080
    China

    Active - Recruiting

  • Shanghai General Hospital - North Campus

    Shanghai 1796236, 200080
    China

    Site Not Available

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612
    Puerto Rico

    Active - Recruiting

  • Emanuelli Research and Development Center LLC

    Arecibo 4562635, 00612
    Puerto Rico

    Site Not Available

  • 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

  • Arizona Retina and Vitreous Consultants

    Phoenix 5308655, Arizona 5551752 85020-5917
    United States

    Active - Recruiting

  • Associated Retinal Consultants PC

    Phoenix 5308655, Arizona 5551752 85020
    United States

    Site Not Available

  • Barnet Dulaney Perkins Eye Center

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Site Not Available

  • Retinal Research Institute, LLC

    Phoenix 5308655, Arizona 5551752 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

  • University of California San Francisco

    San Francisco, California 94158
    United States

    Active - Recruiting

  • Macula Retina Vitreous Research Institute

    Torrance, California 90503-3270
    United States

    Active - Recruiting

  • Bay Area Retina Associates;Study Department

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Retinal Diagnostic Center

    Campbell 5333689, California 5332921 95008
    United States

    Site Not Available

  • The Retina Partners

    Encino 5346649, California 5332921 91436
    United States

    Site Not Available

  • Retina Consultants of Orange County

    Fullerton 5351247, California 5332921 92835
    United States

    Site Not Available

  • Retinal Consultants Medical Group

    Modesto 5373900, California 5332921 95356-9412
    United States

    Site Not Available

  • Northern California Retina-Vitreous Associates

    Mountain View 5375480, California 5332921 94040
    United States

    Site Not Available

  • Retinal Consultants Medical Group

    Sacramento 5389489, California 5332921 95825
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco 5391959, California 5332921 94158
    United States

    Site Not Available

  • Macula Retina Vitreous Research Institute

    Torrance 5403022, California 5332921 90503-3270
    United States

    Site Not Available

  • Bay Area Retina Associates;Study Department

    Walnut Creek 5406990, California 5332921 94598
    United States

    Site Not Available

  • Retina Specialists of Colorado

    Aurora, Colorado 80012
    United States

    Site Not Available

  • University of Colorado - Eye Center - PPDS

    Aurora, Colorado 80045-2517
    United States

    Active - Recruiting

  • 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

  • University of Colorado - Eye Center - PPDS

    Aurora 5412347, Colorado 5417618 80045-2517
    United States

    Site Not Available

  • Retina Consultants of Southern Colorado PC

    Colorado Springs 5417598, Colorado 5417618 80909
    United States

    Site Not Available

  • Retina Specialists of Colorado

    Denver 5419384, Colorado 5417618 80222
    United States

    Site Not Available

  • Advanced Vision Research Institute

    Longmont 5579276, Colorado 5417618 80503-6499
    United States

    Site Not Available

  • Retina Group of New England

    Waterford, Connecticut 06385-1215
    United States

    Active - Recruiting

  • Retina Group of New England

    Waterford 8480031, Connecticut 4831725 06385-1215
    United States

    Site Not Available

  • Blue Ocean Clinical Research

    Clearwater, Florida 33761-2046
    United States

    Site Not Available

  • 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

  • Blue Ocean Clinical Research

    Clearwater 4151316, Florida 4155751 33761-2046
    United States

    Site Not Available

  • National Ophthalmic Research Institute

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Site Not Available

  • Florida Retina Institute

    Jacksonville 4160021, Florida 4155751 32216-6347
    United States

    Site Not Available

  • Retina Associates of Florida;Retina Associates of Florida

    Tampa 4174757, Florida 4155751 33609
    United States

    Site Not Available

  • Southeast Retina Center

    Augusta, Georgia 30909-6440
    United States

    Active - Recruiting

  • Georgia Retina PC

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Southeast Retina Center

    Augusta 4180531, Georgia 4197000 30909-6440
    United States

    Site Not Available

  • Georgia Retina PC

    Marietta 4207783, Georgia 4197000 30060
    United States

    Site Not Available

  • Retina Consultants of Hawaii

    'Aiea, Hawaii 96701
    United States

    Site Not Available

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii 96701
    United States

    Active - Recruiting

  • Retina Consultants of Hawaii

    ‘Aiea 5856430, Hawaii 5855797 96701
    United States

    Site Not Available

  • Illinois Eye and Ear Infirmary

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • University Retina and Macula Associates, PC

    Lemont, Illinois 60439
    United States

    Site Not Available

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois 60452
    United States

    Active - Recruiting

  • Illinois Eye and Ear Infirmary

    Chicago 4887398, Illinois 4896861 60612
    United States

    Site Not Available

  • University Retina and Macula Associates, PC

    Oak Forest 4904286, Illinois 4896861 60452
    United States

    Site Not Available

  • Raj K. Maturi, MD PC

    Indianapolis, Indiana 46290
    United States

    Completed

  • Raj K. Maturi, MD PC

    Indianapolis 4259418, Indiana 4921868 46290
    United States

    Site Not Available

  • 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

  • Chesapeake Retina Centers - Waldorf

    Waldorf, Maryland 20602
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • The Retina Care Center

    Baltimore 4347778, Maryland 4361885 21209
    United States

    Site Not Available

  • Retina Group of Washington

    Chevy Chase 4351335, Maryland 4361885 20815
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Site Not Available

  • Chesapeake Retina Centers - Waldorf

    Waldorf 4372599, Maryland 4361885 20602
    United States

    Site Not Available

  • Associated Retinal Consultants - Royal Oak

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Associated Retinal Consultants - Royal Oak

    Royal Oak 5007804, Michigan 5001836 48073
    United States

    Site Not Available

  • Retina Consultants Minnesota

    Saint Louis Park, Minnesota 55416
    United States

    Active - Recruiting

  • Retina Consultants Minnesota

    Saint Louis Park 5045021, Minnesota 5037779 55416
    United States

    Site Not Available

  • 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

  • Opthalmic Consultants of LI

    Lynbrook, New York 11563
    United States

    Active - Recruiting

  • Long Island Vitreoretinal Consultants;Opthalmology

    Hauppauge 5120228, New York 5128638 11788
    United States

    Site Not Available

  • Retina Vitreous Surgeons of CNY PC

    Liverpool 5124925, New York 5128638 13088
    United States

    Site Not Available

  • Opthalmic Consultants of LI

    Lynbrook 5125523, New York 5128638 11563
    United States

    Site Not Available

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • North Carolina Retina Associates

    Cary, North Carolina 27511
    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

  • North Carolina (NC) Retina Associates - Wake Forest Office

    Wake Forest, North Carolina 27587-3803
    United States

    Active - Recruiting

  • Piedmont Retina Specialists

    Winston-Salem, North Carolina 27103-6970
    United States

    Active - Recruiting

  • Western Carolina Retinal Associate PA

    Asheville 4453066, North Carolina 4482348 28803
    United States

    Site Not Available

  • North Carolina Retina Associates

    Cary 4459467, North Carolina 4482348 27511
    United States

    Site Not Available

  • Duke University Medical Center

    Durham 4464368, North Carolina 4482348 27705
    United States

    Site Not Available

  • Graystone Eye

    Hickory 4470778, North Carolina 4482348 28602
    United States

    Site Not Available

  • North Carolina (NC) Retina Associates - Wake Forest Office

    Wake Forest 4497290, North Carolina 4482348 27587-3803
    United States

    Site Not Available

  • Piedmont Retina Specialists

    Winston-Salem 4499612, North Carolina 4482348 27103-6970
    United States

    Site Not Available

  • Cincinnati Eye Institute

    Blue Ash, Ohio 45242-5537
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44016
    United States

    Active - Recruiting

  • Ohio State Eye and Ear Institute

    Columbus, Ohio 43212
    United States

    Active - Recruiting

  • Cincinnati Eye Institute

    Blue Ash 4506754, Ohio 5165418 45242-5537
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44016
    United States

    Site Not Available

  • Ohio State Eye and Ear Institute

    Columbus 4509177, Ohio 5165418 43212
    United States

    Site Not Available

  • Tulsa Retina Consultants

    Tulsa, Oklahoma 74114
    United States

    Active - Recruiting

  • Tulsa Retina Consultants

    Tulsa 4553433, Oklahoma 4544379 74114
    United States

    Site Not Available

  • Cascade Medical Research Institute LLC

    Springfield, Oregon 97477
    United States

    Active - Recruiting

  • Cascade Medical Research Institute LLC

    Springfield 5754005, Oregon 5744337 97477
    United States

    Site Not Available

  • Erie Retina Research

    Erie, Pennsylvania 16505
    United States

    Active - Recruiting

  • Wills Eye Hospital

    Philadelphia, Pennsylvania 19107-5109
    United States

    Active - Recruiting

  • Sewickely Eye Group

    Sewickley, Pennsylvania 15143
    United States

    Active - Recruiting

  • Erie Retina Research

    Erie 5188843, Pennsylvania 6254927 16505
    United States

    Site Not Available

  • Wills Eye Hospital

    Philadelphia 4560349, Pennsylvania 6254927 19107-5109
    United States

    Site Not Available

  • Sewickely Eye Group

    Sewickley 5211506, Pennsylvania 6254927 15143
    United States

    Site Not Available

  • Palmetto Retina Center

    West Columbia, South Carolina 29169-2429
    United States

    Active - Recruiting

  • Palmetto Retina Center

    West Columbia 4600541, South Carolina 4597040 29169-2429
    United States

    Site Not Available

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Charles Retina Institute

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Site Not Available

  • 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 Research Institute of Texas

    Abilene 4669635, Texas 4736286 79606
    United States

    Site Not Available

  • Texas Retina Associates

    Arlington 4671240, Texas 4736286 76012
    United States

    Site Not Available

  • Austin Clinical Research LLC

    Austin 4671654, Texas 4736286 78750
    United States

    Site Not Available

  • Austin Retina Associates

    Austin 4671654, Texas 4736286 78705
    United States

    Active - Recruiting

  • Retina & Vitreous of Texas

    Bellaire 4673353, Texas 4736286 77401
    United States

    Site Not Available

  • Texas Retina Associates

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • Valley Retina Institute P.A.

    McAllen 4709796, Texas 4736286 78550-9207
    United States

    Site Not Available

  • Brown Retina Institute

    San Antonio 4726206, Texas 4736286 78251-4551
    United States

    Site Not Available

  • Medical Center Ophthalmology Associates

    San Antonio 4726206, Texas 4736286 78240
    United States

    Active - Recruiting

  • Retina Consultants of Texas - San Antonio

    San Antonio 4726206, Texas 4736286 78240
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    The Woodlands 4736476, Texas 4736286 77384
    United States

    Site Not Available

  • Strategic Clinical Research Group, LLC

    Willow Park 4742296, Texas 4736286 76087
    United States

    Site Not Available

  • Retina Associates of Utah, PLLC;Clinical Research

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Retina Associates of Utah, PLLC;Clinical Research

    Salt Lake City 5780993, Utah 5549030 84107
    United States

    Site Not Available

  • 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

  • Virginia Eye Institute - Richmond - 7301 Forest Ave

    Richmond, Virginia 23230
    United States

    Active - Recruiting

  • Piedmont Eye Center

    Lynchburg 4771075, Virginia 6254928 24502-4271
    United States

    Site Not Available

  • Wagner Kapoor Institute

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Site Not Available

  • Retina Institute of Virginia

    Richmond 4781708, Virginia 6254928 23235-1962
    United States

    Active - Recruiting

  • Virginia Eye Institute - Richmond - 7301 Forest Ave

    Richmond 4781708, Virginia 6254928 23230
    United States

    Site Not Available

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Active - Recruiting

  • Spokane Eye Clinical Research

    Spokane 5811696, Washington 5815135 99204
    United States

    Site Not Available

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