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New drug aims to slow vision loss in Age-Related blindness

NCT ID NCT06769048

Disease control Sponsor: Boehringer Ingelheim 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 29, 2026 · Updated 4 times

Summary

This study tests a drug called BI 1584862 in 150 adults aged 50+ with geographic atrophy, an advanced form of age-related macular degeneration that causes blind spots. Participants receive either the drug or a placebo for 1 year. Doctors track changes in the retina using special imaging to see if the drug slows the growth of damaged areas.

What this could mean

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

Active substance
BI 1584862
What this could lead to
If it works, this could point toward a treatment to slow vision loss from geographic atrophy, a leading cause of blindness.
What could go wrong
This is an early Phase 2 trial with only 150 people. The drug may not slow the disease or could have side effects. Results may not apply to all patients.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

150 people

The number who actually took part.

Started

Jan 2025

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

50 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: * Men and women with at least 1 eye with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) determined by fundus autofluorescence (FAF). The total size of all GA lesions in the study eye (as determined by the independent central reading center (CRC)) must be ≥1.25 mm\^2 and ≤12.0 mm\^2: * If multiple lesions are present in the study eye, at least 1 lesion must have an area of ≥0.5 mm\^2 * At least 1 GA lesion must be at least in part within a 1500 μm radius ring centered on the fovea * The foveal center point must not be involved in any atrophic lesion * Lesion(s) must reside completely within the FAF image * Best corrected visual acuity (BCVA) score of ≥50 letters in the study eye using the early treatment diabetic retinopathy study (ETDRS) chart (approximately equivalent to ≥20/100 on the Snellen chart). * Hyperautofluorescence of any pattern, as assessed by the CRC, must be present in the junctional zone of GA in the study eye. * Age ≥50 years. * Men must be willing and able to use contraception (condom, abstinence) to prevent pregnancy and/or exposure of an existing embryo or fetus to the investigational product. A female participant is eligible if she is not a woman of childbearing potential. * Signed informed consent consistent with International Conference of Harmonization-Good Clinical Practice (ICH GCP) guidelines and local legislation Exclusion criteria: * Any history of, or evidence of, exudative age-related macular degeneration (eAMD) in the study eye. * Previously received treatment for GA in the study eye within 4 months or 5 half-lives, prior to baseline, whichever is longer. * Previously received an investigational medication (oral or intravitreal) for GA within 4 months or 5 half-lives prior to baseline, whichever is longer. * Additional eye disease in the study eye that could compromise BCVA or significantly impact retinal morphology: * uncontrolled glaucoma, defined as a disk-to-cup ratio \>0.8 or ocular hypertension with intra ocular pressure (IOP) \>24 mmHg at screening visit, or use of \>2 active IOP-lowering agents in the study eye * clinically significant diabetic retinopathy or maculopathy in the opinion of the investigator * history of high myopia, i.e. spherical equivalent of ≥8 diopters or axial length ≥27.2 mm. Note: if subject had prior cataract or refractive surgery, spherical equivalent should be evaluated with pre-operative refraction. If axial length measurement is not available in medical records and cannot be obtained at screening visit, assessment of high myopia can be made by investigator on clinical examination. * anterior segment and vitreous abnormalities that would preclude adequate observation with SD-OCT in the opinion of the investigator * other ocular conditions at the discretion of the investigator that might interfere with the outcome of the trial * Significant disease or other medical conditions (as determined by medical history, examination, and clinical investigations at screening) that may, in the opinion of the investigator result in any of the following: * put the participant at risk because of participation in the study * influence the results of the study * cause concern regarding the participant's ability to comply with the protocol requirements or complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the participant an unreliable trial participant) * Known hypersensitivity to any of the ingredients used in the investigational medicinal product (IMP) formulation, or any of the medications used. * Active intraocular inflammation in the study eye. * Active infectious conjunctivitis in either eye. Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration dry age related macular degeneration Geographic Atrophy

As listed by the trial registrant

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

Geographic atrophy

Contacts and locations

Locations

  • Associated Retina Consultants

    Gilbert, Arizona, 85297, United States

  • Associated Retina Consultants, Ltd.

    Phoenix, Arizona, 85020, United States

  • Austin Clinical Research, LLC

    Austin, Texas, 78750, United States

  • Bay Area Retina Associates - Walnut Creek

    Walnut Creek, California, 94598, United States

  • Cameron Ria, LLC

    Phoenix, Arizona, 85050, United States

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880, United States

  • Charleston Neuroscience Institute - Charleston

    Charleston, South Carolina, 29414, United States

  • Coastal Eye Surgeons

    Greenwich, Connecticut, 06830, United States

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740, United States

  • East Florida Eye Institute

    Stuart, Florida, 34994, United States

  • Emanuelli Research & Development Center

    Arecibo, 00612, Puerto Rico

  • Emerson Clinical Research Institute

    Falls Church, Virginia, 22042, United States

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782, United States

  • Eye Research Foundation

    Newport Beach, California, 92663, United States

  • EyeHealth Northwest

    Portland, Oregon, 97225, United States

  • Global Research Management

    Glendale, California, 91204, United States

  • Illinois Retina Associates - Oak Park

    Oak Park, Illinois, 60304, United States

  • MedEye Associates

    Miami, Florida, 33143, United States

  • Mid Atlantic Retina - Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • NJRetina

    Teaneck, New Jersey, 07666, United States

  • Northern California Retina Vitreous Associates MedicalGroup, Inc.

    Mountain View, California, 94040, United States

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114, United States

  • Pacific Northwest Retina

    Bellevue, Washington, 98004, United States

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Red River Research Partners, LLC - Plano

    Plano, Texas, 75024, United States

  • Retina Associates of Southern California

    Huntington Beach, California, 92647, United States

  • Retina Consultants of San Diego

    Poway, California, 92064, United States

  • Retina Consultants of Texas - Schertz

    Schertz, Texas, 78154, United States

  • Retina Consultants of Texas-Beaumont-70319

    Beaumont, Texas, 77707, United States

  • Retina Consultants of Texas-The Woodlands-67575

    The Woodlands, Texas, 77384, United States

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231, United States

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona, 85255, United States

  • Retina Northwest

    Portland, Oregon, 97221, United States

  • Retina Specialists of Colorado Research, LLC

    Denver, Colorado, 80222, United States

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211, United States

  • Retinal Consultants Medical Group

    Sacramento, California, 95825, United States

  • Retinal Consultants Medical Group, Inc

    Modesto, California, 95356, United States

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240, United States

  • Southeast Retina Center, PC

    Augusta, Georgia, 30909, United States

  • Tennessee Retina

    Nashville, Tennessee, 37203, United States

  • The Eye Care Institute

    Louisville, Kentucky, 40206, United States

  • University of Missouri Health System

    Columbia, Missouri, 65212, United States

  • Verum Research, LLC

    Eugene, Oregon, 97401, United States

  • Vitreo Retinal Associates - Gainesville

    Gainesville, Florida, 32605, United States

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