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
- Diseases
- Macular degeneration
- 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
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emanuelli Research & Development Center Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Unknown status |
| Southeast Retina Center, PC Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
| Austin Clinical Research, LLC Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Retina Consultants of Texas - Beaumont Coordinator of this site? Confirm its status | Beaumont | United States | Unknown status |
| Pacific Northwest Retina Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Retina-Vitreous Associates Medical Group Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Ophthalmic Consultants of Boston Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Charleston Neuroscience Institute - Charleston Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| University of Missouri Health System Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Retina Foundation of the Southwest Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Retina Specialists of Colorado Research, LLC Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Verum Research, LLC Coordinator of this site? Confirm its status | Eugene | United States | Unknown status |
| Emerson Clinical Research Institute Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
| Vitreo Retinal Associates - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Associated Retina Consultants Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Global Research Management Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Coastal Eye Surgeons Coordinator of this site? Confirm its status | Greenwich | United States | Unknown status |
| Cumberland Valley Retina Consultants Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Retina Associates of Southern California Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| The Eye Care Institute Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Piedmont Eye Center Coordinator of this site? Confirm its status | Lynchburg | United States | Unknown status |
| MedEye Associates Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Retinal Consultants Medical Group, Inc Coordinator of this site? Confirm its status | Modesto | United States | Unknown status |
| Northern California Retina Vitreous Associates MedicalGroup, Inc. Coordinator of this site? Confirm its status | Mountain View | United States | Unknown status |
| Tennessee Retina Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Eye Research Foundation Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Illinois Retina Associates - Oak Park Coordinator of this site? Confirm its status | Oak Park | United States | Unknown status |
| Mid Atlantic Retina - Wills Eye Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Cameron Ria, LLC Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Associated Retina Consultants, Ltd. Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Eye Associates of Pinellas Coordinator of this site? Confirm its status | Pinellas Park | United States | Unknown status |
| Red River Research Partners, LLC - Plano Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Retina Northwest Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| EyeHealth Northwest Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Retina Consultants of San Diego Coordinator of this site? Confirm its status | Poway | United States | Unknown status |
| Retinal Consultants Medical Group Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Retinal Consultants of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Retina Consultants of Texas - Schertz Coordinator of this site? Confirm its status | Schertz | United States | Unknown status |
| Retina Macula Institute of Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| East Florida Eye Institute Coordinator of this site? Confirm its status | Stuart | United States | Unknown status |
| NJRetina Coordinator of this site? Confirm its status | Teaneck | United States | Unknown status |
| Retina Consultants of Texas-The Woodlands-67575 Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Bay Area Retina Associates - Walnut Creek Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
| Center for Retina and Macular Disease Coordinator of this site? Confirm its status | Winter Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.