ACTIVE_NOT_RECRUITING

A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is open to adults aged 50 years and older with geographic atrophy that was diagnosed by imaging of the retina. The purpose of this study is to find out whether a medicine called BI 1584862 improves the eyes in people with geographic atrophy and to find the most suitable dose. This study has 4 treatment groups. Participants are put into groups randomly, which means by chance. Initially participants can join a BI 1584862 and a placebo group; then more participants are put randomly in 2 additional BI 1584862 groups and a placebo group. Participants are in the study for 1 year. During this time, they visit the study site 13 times. At the visits, doctors check the severity of participants' eye disease and collect information on any health problems. They take detailed pictures of the back of the eye, the retina, with imaging methods called fundus autofluorescence (FAF), near-infrared reflectance (NIR), and optical coherence tomography (OCT). They measure areas of the retina that appear healthy (bright) or start to waste away (dark, atrophy). The changes over time are then compared between the treatment groups.

Official Title

JADE: Phase II Trial in Patients With Geographic Atrophy: A Randomized, Double-masked, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of BI 1584862

Quick Facts

Study Start:2025-01-31

Study Completion:2027-02-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06769048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Locations (Sites)

Associated Retina Consultants

Gilbert, Arizona, 85297

United States

Associated Retina Consultants, Ltd.

Phoenix, Arizona, 85020

United States

Cameron Ria, LLC

Phoenix, Arizona, 85050

United States

Retina Macula Institute of Arizona

Scottsdale, Arizona, 85255

United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211

United States

Global Research Management

Glendale, California, 91204

United States

Retina Associates of Southern California

Huntington Beach, California, 92647

United States

Retinal Consultants Medical Group, Inc

Modesto, California, 95356

United States

Northern California Retina Vitreous Associates MedicalGroup, Inc.

Mountain View, California, 94040

United States

Eye Research Foundation

Newport Beach, California, 92663

United States

Retina Consultants of San Diego

Poway, California, 92064

United States

Retinal Consultants Medical Group

Sacramento, California, 95825

United States

Bay Area Retina Associates - Walnut Creek

Walnut Creek, California, 94598

United States

Retina Specialists of Colorado Research, LLC

Denver, Colorado, 80222

United States

Coastal Eye Surgeons

Greenwich, Connecticut, 06830

United States

Vitreo Retinal Associates - Gainesville

Gainesville, Florida, 32605

United States

MedEye Associates

Miami, Florida, 33143

United States

Eye Associates of Pinellas

Pinellas Park, Florida, 33782

United States

East Florida Eye Institute

Stuart, Florida, 34994

United States

Center for Retina and Macular Disease

Winter Haven, Florida, 33880

United States

Southeast Retina Center, PC

Augusta, Georgia, 30909

United States

Illinois Retina Associates - Oak Park

Oak Park, Illinois, 60304

United States

The Eye Care Institute

Louisville, Kentucky, 40206

United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740

United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114

United States

University of Missouri Health System

Columbia, Missouri, 65212

United States

NJRetina

Teaneck, New Jersey, 07666

United States

Verum Research, LLC

Eugene, Oregon, 97401

United States

Retina Northwest

Portland, Oregon, 97221

United States

EyeHealth Northwest

Portland, Oregon, 97225

United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107

United States

Charleston Neuroscience Institute - Charleston

Charleston, South Carolina, 29414

United States

Tennessee Retina

Nashville, Tennessee, 37203

United States

Austin Clinical Research, LLC

Austin, Texas, 78750

United States

Retina Consultants of Texas-Beaumont-70319

Beaumont, Texas, 77707

United States

Retina Foundation of the Southwest

Dallas, Texas, 75231

United States

Red River Research Partners, LLC - Plano

Plano, Texas, 75024

United States

Retinal Consultants of San Antonio

San Antonio, Texas, 78240

United States

Retina Consultants of Texas - Schertz

Schertz, Texas, 78154

United States

Retina Consultants of Texas-The Woodlands-67575

The Woodlands, Texas, 77384

United States

Emerson Clinical Research Institute

Falls Church, Virginia, 22042

United States

Piedmont Eye Center

Lynchburg, Virginia, 24502

United States

Pacific Northwest Retina

Bellevue, Washington, 98004

United States

Collaborators and Investigators

Sponsor: Boehringer Ingelheim

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-31

Study Completion Date2027-02-26

Study Record Updates

Study Start Date2025-01-31

Study Completion Date2027-02-26

Terms related to this study

Additional Relevant MeSH Terms

Geographic Atrophy