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New combo eye injection shows promise for Diabetes-Related vision loss

NCT ID NCT06850922

Disease control Sponsor: Genentech, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called RO7446603, given alone or with existing medications (aflibercept or faricimab), for people with diabetic macular edema—a condition that causes vision loss due to diabetes. The trial has two parts: an early safety phase (Phase I) and a later phase (Phase II) comparing the new drug combined with faricimab against faricimab alone. About 546 participants will be enrolled to see if the combination is safe and improves vision better than current treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RO7446603 (an experimental drug injected into the eye), aflibercept, and faricimab (Vabysmo)
What this could lead to
If successful, this could lead to a new combination treatment that better controls diabetic macular edema and improves vision with fewer injections.
What could go wrong
This is an early-phase trial (Phase I/II) with a small number of participants so far. The experimental drug may not work better than existing treatments, and eye injections carry risks like infection or inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

388 people

The number who actually took part.

Started

Jun 2022

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented diagnosis of diabetes mellitus (DM) (Type 1 or Type 2) with glycated hemoglobin (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 Criteria: * Currently untreated DM or previously untreated participants who initiated oral anti-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 treatment prior 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 to Day 1 * Any current or history of ocular disease other than DME that may confound assessment of 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 in either eye Other protocol-specified inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema

Contacts and locations

Locations

  • Advanced Vision Research Institute

    Longmont, Colorado, 80503-6499, United States

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85020-5917, United States

  • Associated Retinal Consultants - Royal Oak

    Royal Oak, Michigan, 48073, United States

  • Associated Retinal Consultants PC

    Phoenix, Arizona, 85020, United States

  • Austin Clinical Research LLC

    Austin, Texas, 78750, United States

  • Austin Retina Associates

    Austin, Texas, 78705, United States

  • Bay Area Retina Associates;Study Department

    Walnut Creek, California, 94598, United States

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730, China

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730, China

  • Brown Retina Institute

    San Antonio, Texas, 78251-4551, United States

  • Cascade Medical Research Institute LLC

    Springfield, Oregon, 97477, United States

  • Charles Retina Institute

    Germantown, Tennessee, 38138, United States

  • Chesapeake Retina Centers - Waldorf

    Waldorf, Maryland, 20602, United States

  • Cincinnati Eye Institute

    Blue Ash, Ohio, 45242-5537, United States

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612, Puerto Rico

  • Erie Retina Research

    Erie, Pennsylvania, 16505, United States

  • Eye Hospital,WMU(Zhejiang Eye Hospital)

    Wenzhou, Zhejiang, 325027, China

  • Florida Retina Institute

    Jacksonville, Florida, 32216-6347, United States

  • Georgia Retina PC

    Marietta, Georgia, 30060, United States

  • Graystone Eye-Hickory

    Hickory, North Carolina, 28602, United States

  • Illinois Eye and Ear Infirmary

    Chicago, Illinois, 60612, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Long Island Vitreoretinal Consultants;Opthalmology

    Hauppauge, New York, 11788, United States

  • Macula Retina Vitreous Research Institute

    Torrance, California, 90503-3270, United States

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240, United States

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912, United States

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

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

  • North Carolina Retina Associates

    Cary, North Carolina, 27511, United States

  • Northern California Retina-Vitreous Associates

    Mountain View, California, 94040, United States

  • Ohio State Eye and Ear Institute

    Columbus, Ohio, 43212, United States

  • Opthalmic Consultants of LI

    Lynbrook, New York, 11563, United States

  • Palmetto Retina Center

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

  • Peking Union Medical College Hospital

    Beijing, 100730, China

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502-4271, United States

  • Piedmont Retina Specialists

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

  • Raj K. Maturi, MD PC

    Indianapolis, Indiana, 46290, United States

  • Retina & Vitreous of Texas

    Bellaire, Texas, 77401, United States

  • Retina Associates of Florida;Retina Associates of Florida

    Tampa, Florida, 33609, United States

  • Retina Associates of Utah, PLLC;Clinical Research

    Salt Lake City, Utah, 84107, United States

  • Retina Consultants Minnesota

    Saint Louis Park, Minnesota, 55416, United States

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701, United States

  • Retina Consultants of Orange County

    Fullerton, California, 92835, United States

  • Retina Consultants of Southern Colorado PC

    Colorado Springs, Colorado, 80909, United States

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384, United States

  • Retina Consultants of Texas - San Antonio

    San Antonio, Texas, 78240, United States

  • Retina Group of New England

    Waterford, Connecticut, 06385-1215, United States

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815, United States

  • Retina Institute of Virginia

    Richmond, Virginia, 23235-1962, United States

  • Retina Partners of Northwest Arkansas, PLLC

    Springdale, Arkansas, 72764, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retina Specialists of Colorado

    Denver, Colorado, 80222, United States

  • Retina Vitreous Surgeons of CNY PC

    Liverpool, New York, 13088, United States

  • Retinal Consultants Medical Group

    Modesto, California, 95356-9412, United States

  • Retinal Consultants Medical Group

    Sacramento, California, 95825, United States

  • Retinal Diagnostic Center

    Campbell, California, 95008, United States

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85053, United States

  • Sewickely Eye Group

    Sewickley, Pennsylvania, 15143, United States

  • Shanghai General Hospital - North Campus

    Shanghai, Shanghai Municipality, 200080, China

  • Southeast Retina Center

    Augusta, Georgia, 30909-6440, United States

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204, United States

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087, United States

  • Texas Retina Associates

    Arlington, Texas, 76012, United States

  • Texas Retina Associates

    Dallas, Texas, 75231, United States

  • The Retina Care Center

    Baltimore, Maryland, 21209, United States

  • Tianjin Medical University Eye Hospital

    Tianjin, Tianjin Municipality, 300384, China

  • Tulsa Retina Consultants

    Tulsa, Oklahoma, 74114, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44016, United States

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452, United States

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • University of Colorado - Eye Center - PPDS

    Aurora, Colorado, 80045-2517, United States

  • Valley Retina Institute P.A.

    McAllen, Texas, 78550-9207, United States

  • Virginia Eye Institute - Richmond - 7301 Forest Ave

    Richmond, Virginia, 23230, United States

  • Wagner Kapoor Institute

    Norfolk, Virginia, 23502, United States

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803, United States

  • Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107-5109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.