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NCT06769048Active, not recruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
150 (actual)
First submitted
7 Jan 2025
Start date
31 Jan 2025
Primary completion date
22 Dec 2026
Lead sponsor
Boehringer Ingelheim
NCT number
NCT06769048

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 150
  • From 31 Jan 2025 to the primary completion date, 22 Dec 2026
  • 44 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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.

Age

  • Any history of, or evidence of, exudative age-related macular degeneration (eAMD) in the study eye.

Other

  • Active intraocular inflammation in the study eye.
  • Active infectious conjunctivitis in either eye. Further exclusion criteria apply.

Who the study is looking for

  • 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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emanuelli Research & Development Center
Coordinator of this site? Confirm its status
AreciboPuerto RicoUnknown status
Southeast Retina Center, PC
Coordinator of this site? Confirm its status
AugustaUnited StatesUnknown status
Austin Clinical Research, LLC
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Retina Consultants of Texas - Beaumont
Coordinator of this site? Confirm its status
BeaumontUnited StatesUnknown status
Pacific Northwest Retina
Coordinator of this site? Confirm its status
BellevueUnited StatesUnknown status
Retina-Vitreous Associates Medical Group
Coordinator of this site? Confirm its status
Beverly HillsUnited StatesUnknown status
Ophthalmic Consultants of Boston
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BostonUnited StatesUnknown status
Charleston Neuroscience Institute - Charleston
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CharlestonUnited StatesUnknown status
University of Missouri Health System
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ColumbiaUnited StatesUnknown status
Retina Foundation of the Southwest
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DallasUnited StatesUnknown status
Retina Specialists of Colorado Research, LLC
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DenverUnited StatesUnknown status
Verum Research, LLC
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EugeneUnited StatesUnknown status
Emerson Clinical Research Institute
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Falls ChurchUnited StatesUnknown status
Vitreo Retinal Associates - Gainesville
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GainesvilleUnited StatesUnknown status
Associated Retina Consultants
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GilbertUnited StatesUnknown status
Global Research Management
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GlendaleUnited StatesUnknown status
Coastal Eye Surgeons
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GreenwichUnited StatesUnknown status
Cumberland Valley Retina Consultants
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HagerstownUnited StatesUnknown status
Retina Associates of Southern California
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Huntington BeachUnited StatesUnknown status
The Eye Care Institute
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LouisvilleUnited StatesUnknown status
Piedmont Eye Center
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LynchburgUnited StatesUnknown status
MedEye Associates
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MiamiUnited StatesUnknown status
Retinal Consultants Medical Group, Inc
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ModestoUnited StatesUnknown status
Northern California Retina Vitreous Associates MedicalGroup, Inc.
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Mountain ViewUnited StatesUnknown status
Tennessee Retina
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NashvilleUnited StatesUnknown status
Eye Research Foundation
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Newport BeachUnited StatesUnknown status
Illinois Retina Associates - Oak Park
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Oak ParkUnited StatesUnknown status
Mid Atlantic Retina - Wills Eye Hospital
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PhiladelphiaUnited StatesUnknown status
Cameron Ria, LLC
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PhoenixUnited StatesUnknown status
Associated Retina Consultants, Ltd.
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PhoenixUnited StatesUnknown status
Eye Associates of Pinellas
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Pinellas ParkUnited StatesUnknown status
Red River Research Partners, LLC - Plano
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PlanoUnited StatesUnknown status
Retina Northwest
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PortlandUnited StatesUnknown status
EyeHealth Northwest
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PortlandUnited StatesUnknown status
Retina Consultants of San Diego
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PowayUnited StatesUnknown status
Retinal Consultants Medical Group
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SacramentoUnited StatesUnknown status
Retinal Consultants of San Antonio
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San AntonioUnited StatesUnknown status
Retina Consultants of Texas - Schertz
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SchertzUnited StatesUnknown status
Retina Macula Institute of Arizona
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ScottsdaleUnited StatesUnknown status
East Florida Eye Institute
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StuartUnited StatesUnknown status
NJRetina
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TeaneckUnited StatesUnknown status
Retina Consultants of Texas-The Woodlands-67575
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The WoodlandsUnited StatesUnknown status
Bay Area Retina Associates - Walnut Creek
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Walnut CreekUnited StatesUnknown status
Center for Retina and Macular Disease
Coordinator of this site? Confirm its status
Winter HavenUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.