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New eye drug shows promise for Diabetes-Related vision loss

NCT ID NCT06847854

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This early-stage study tests a new drug, RO7497372, given as an eye injection for people with diabetic macular edema (DME), a condition that causes vision loss. The trial involves 151 participants and aims to check the drug's safety, how long it stays in the eye and blood, and its effects. It is split into two parts: first, testing different doses openly, then comparing two doses in a masked study.

What this could mean

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

Active substance
RO7497372 (injected into the eye)
What this could lead to
If successful, this could lead to a new treatment option for diabetic macular edema, potentially reducing vision loss.
What could go wrong
This is an early Phase 1 trial with only 151 participants, so safety and effectiveness are not yet proven. There are risks of eye inflammation or other side effects.

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

151 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Jan 2027

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 * Participant consents to AH collection * Collection of \> 90 microlitres (µL) AH (at each visit required per schedule of activities \[SoA\]) 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 (both inclusive) at screening * Adequately clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images * Diagnosis of non-proliferative DR * Treatment-naive and Pre-treated participants after washout 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) or myocardial infarction ≤ 24 weeks prior to Day 1 * HbA1c ≥ 12% at screening * Any panretinal photocoagulation or macular laser photocoagulation treatment prior to Day 1 * History of vitreoretinal surgery/pars plana vitrectomy * Any cataract surgery within 12 weeks prior to Day 1 or any planned surgery during the 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 receptor treatment at any time * Any proliferative DR

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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

  • Arkansas Retina Research

    Little Rock, Arkansas, 72205, United States

  • Associated Retina Consultants

    Phoenix, Arizona, 85020, United States

  • Austin Clinical Research LLC

    Austin, Texas, 78750, United States

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona, 85206, United States

  • Bay Area Retina Associates

    Walnut Creek, California, 94598, United States

  • Brown Retina Institute

    Schertz, Texas, 78154, United States

  • Carolina Eyecare Physicians

    Mt. Pleasant, South Carolina, 29464, United States

  • Center for Retina and Macula Disease

    Winter Haven, Florida, 33880, United States

  • Charles Retina Institute

    Germantown, Tennessee, 38138, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44106, United States

  • Cumberland Valley Retina PC

    Hagerstown, Maryland, 21740, United States

  • East Florida Eye Institute

    Stuart, Florida, 34994, United States

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612, Puerto Rico

  • Emerson Clinical Research Institute

    Falls Church, Virginia, 78503, United States

  • Erie Retinal Surgery

    Erie, Pennsylvania, 16507, United States

  • EyeHealth Northwest

    Portland, Oregon, 97225, United States

  • Florida Eye Associates

    Melbourne, Florida, 32901, United States

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49546, United States

  • Global Research Management

    Glendale, California, 91204, United States

  • Medeye Associates

    South Miami, Florida, 33143, United States

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19107, United States

  • Mississippi Retina Associates

    Madison, Mississippi, 39202, United States

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Retina Associates of Michigan

    Grand Blanc, Michigan, 48439, United States

  • Retina Associates of NY

    New York, New York, 10075, United States

  • Retina Consultants Minnesota

    Saint Louis Park, Minnesota, 55416, United States

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384, United States

  • Retina Group of Washington

    Fairfax, Virginia, 20815, United States

  • Retina Specialists of Tampa

    Wesley Chapel, Florida, 33544, United States

  • Retinal Consultants Medical Group

    Modesto, California, 95356, United States

  • Retinal Consultants of AZ, Ltd

    Peoria, Arizona, 85381, United States

  • Ross Eye Institute

    Buffalo, New York, 14209, United States

  • Salt Lake Retina

    West Jordan, Utah, 84088, United States

  • Sierra Eye Associates

    Reno, Nevada, 89502, United States

  • Spokane Eye Clinic

    Spokane, Washington, 99204, United States

  • The Retina Institute

    St Louis, Missouri, 63128, United States

  • Verum Research LLC

    Eugene, Oregon, 97401, United States

  • Wagner Kapoor Institute

    Norfolk, Virginia, 23502, United States

More trials for these conditions

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