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New eye drug combo aims to tackle Diabetes-Related vision loss

NCT ID NCT07425522

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 3 times

Summary

This early-stage trial tests an experimental drug called RO7823653, given as an eye injection alone or with an approved drug (faricimab), for people with diabetic macular edema—a condition where diabetes causes fluid buildup and vision loss in the center of the eye. The study will enroll 93 participants to check safety, side effects, and how the drug behaves in the body. It is not yet known if the drug improves vision, as the main goal is to find a safe dose.

What this could mean

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

Active substance
RO7823653 (an experimental drug) and faricimab (an approved drug), both given as eye injections
What this could lead to
If successful, this could point toward a new treatment option for diabetic macular edema that may help reduce retinal swelling and improve vision.
What could go wrong
This is a very early Phase 1 trial with only 93 participants, focused on safety. The drug may not work or could cause side effects like eye inflammation or infection from the injections.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 93 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Nov 2028

An estimate. End dates often move.

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: * Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association * Glycated hemoglobin (HbA1c) \<= 12% * For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) \>= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters Exclusion Criteria: * Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1 * Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required * Uncontrolled blood pressure * For Parts 1 and 2: Any history of ocular injection/implant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF/anti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant. * For Part 3: History of treatment with any of the following: Aflibercept 2 mg, ranibizumab, bevacizumab, or anti-VEGF biosimilars within 90 days prior to Day 1; Aflibercept 8 mg, brolucizumab, or faricimab within 120 days prior to Day 1; Triamcinolone acetonide (IVT, suprachoroidal, or periocular) within 120 days prior to Day 1; Dexamethasone intravitreal implant within 180 days prior to Day 1; Fluocinolone acetonide (FA) intravitreal implant within 3 years prior to Day 1; Device implant * History of uveitis, vitritis (grade trace or above), and/or scleritis in either eye * Active intraocular inflammation in either eye * Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Associated Retina Consultants - Peoria - DocTrials - PPDS

    RECRUITING

    Peoria, Arizona, 85381-3690, United States

  • Austin Clinical Research, LLC

    RECRUITING

    Austin, Texas, 78750-2298, United States

  • Bay Area Retina Specialists Medical Group - Vestrum - PPDS

    RECRUITING

    Walnut Creek, California, 94598-5915, United States

  • Charles Retina Institute

    RECRUITING

    Germantown, Tennessee, 38138-2405, United States

  • Erie Retina Research, LLC - 300 State St

    RECRUITING

    Erie, Pennsylvania, 16507-1429, United States

  • Piedmont Eye Center

    RECRUITING

    Lynchburg, Virginia, 24502-4271, United States

  • Retina Consultants of Texas Westover Hills Retina Center

    RECRUITING

    San Antonio, Texas, 78251, United States

  • Retina Research Institute of Texas

    RECRUITING

    Abilene, Texas, 79606-1224, United States

  • Retina Vitreous Associates of Florida

    RECRUITING

    St. Petersburg, Florida, 33711-1141, United States

  • Retina-Vitreous Associates Medical Group

    RECRUITING

    Beverly Hills, California, 90211-1838, United States

  • Wills Eye Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107-5109, United States

  • Wilmer Eye Institute

    RECRUITING

    Baltimore, Maryland, 21287-0005, United States

More trials for these conditions

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