Geographic AtrophyPhase 2NCT06769048
A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
A Phase 2 study testing BI 1584862 in people with Geographic Atrophy, run by Boehringer Ingelheim at 44 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Geographic Atrophy
- What is being tested?
- BI 1584862
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 44 sitesin 2 countries
- Study dates
- 31 Jan 2025to 5 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
44 sites in 2 countries.
44 sites in 2 countries
United States43 sites
Southeast Retina Center, PC
Augusta, Georgia, 30909
Austin Clinical Research, LLC
Austin, Texas, 78750
Retina Consultants of Texas - Beaumont
Beaumont, Texas, 77707
Pacific Northwest Retina
Bellevue, Washington, 98004
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Charleston Neuroscience Institute - Charleston
Charleston, South Carolina, 29414
University of Missouri Health System
Columbia, Missouri, 65212
Retina Foundation of the Southwest
Dallas, Texas, 75231
Retina Specialists of Colorado Research, LLC
Denver, Colorado, 80222
Verum Research, LLC
Eugene, Oregon, 97401
Emerson Clinical Research Institute
Falls Church, Virginia, 22042
Vitreo Retinal Associates - Gainesville
Gainesville, Florida, 32605
Associated Retina Consultants
Gilbert, Arizona, 85297
Global Research Management
Glendale, California, 91204
Coastal Eye Surgeons
Greenwich, Connecticut, 06830
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Retina Associates of Southern California
Huntington Beach, California, 92647
The Eye Care Institute
Louisville, Kentucky, 40206
Piedmont Eye Center
Lynchburg, Virginia, 24502
MedEye Associates
Miami, Florida, 33143
Retinal Consultants Medical Group, Inc
Modesto, California, 95356
Northern California Retina Vitreous Associates MedicalGroup, Inc.
Mountain View, California, 94040
Tennessee Retina
Nashville, Tennessee, 37203
Eye Research Foundation
Newport Beach, California, 92663
Illinois Retina Associates - Oak Park
Oak Park, Illinois, 60304
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Associated Retina Consultants, Ltd.
Phoenix, Arizona, 85020
Cameron Ria, LLC
Phoenix, Arizona, 85050
Eye Associates of Pinellas
Pinellas Park, Florida, 33782
Red River Research Partners, LLC - Plano
Plano, Texas, 75024
Retina Northwest
Portland, Oregon, 97221
EyeHealth Northwest
Portland, Oregon, 97225
Retina Consultants of San Diego
Poway, California, 92064
Retinal Consultants Medical Group
Sacramento, California, 95825
Retinal Consultants of San Antonio
San Antonio, Texas, 78240
Retina Consultants of Texas - Schertz
Schertz, Texas, 78154
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255
East Florida Eye Institute
Stuart, Florida, 34994
NJRetina
Teaneck, New Jersey, 07666
Retina Consultants of Texas-The Woodlands-67575
The Woodlands, Texas, 77384
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, 94598
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
About this study
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
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.
- Conditions
- Geographic Atrophy
- Being tested
- Placebo-matching BI 1584862, BI 1584862
- Medical subject headings
- Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo-matching BI 1584862Drug
Placebo-matching BI 1584862
BI 1584862Drug
BI 1584862
| Study group | Role | What they receive |
|---|---|---|
| Placebo-matching BI 1584862 | Placebo comparator | Not described Receives: Drug: Placebo-matching BI 1584862 |
| BI 1584862 dose 1 | Experimental | Not described Receives: Drug: BI 1584862 |
| BI 1584862 dose 2 | Experimental | Not described Receives: Drug: BI 1584862 |
| BI 1584862 dose 3 | Experimental | Not described Receives: Drug: BI 1584862 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) over a treatment period of up to 50 weeks (expressed in mm/year) in the study eye
mm is millimeters.
Measured: Up to week 50.
Secondary outcomes (7)
Key secondary endpoint: Change from baseline in total attenuation as a percentage of the EZ at the macular area with a thickness of 0 μm up to week 50 assessed by volumetric OCT and EZ mapping in the study eye
EZ stands for ellipsoid zone. OCT stands for optical coherence tomography.
Measured: Up to week 50.
Key secondary endpoint: Slope of change from baseline in square root transformed GA area as measured by OCT over a trial period of up to 50 weeks (expressed in mm/year) in the study eye
GA stands for geographic atrophy. OCT stands for optical coherence tomography. mm is millimeters.
Measured: Up to week 50.
Occurrence of TEAES from drug administration until Week 52
Measured: Up to week 52.
Change from baseline in partial attenuation as a percentage of the ellipsoid zone (EZ) at the macular area with thickness <20 micrograms (μm) up to week 50 assessed by volumetric optical coherence tomography (OCT) in the study eye
Measured: Up to week 50.
Change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) at Week 50 (expressed in mm) in the study eye
Measured: At baseline and at week 50.
Occurrence of BCVA letter loss of ≥15 from baseline in the study eye as measured by standardized ETDRS chart for at least 2 consecutive visits between baseline and up to Week 50
ETDRS is early treatment diabetic retinopathy study.
Measured: Up to week 50.
Change from baseline in best-corrected low luminance visual deficit (LLVD) score as measured in letters by ETDRS chart under low-luminance conditions at Week 50 in the study eye
ETDRS is early treatment diabetic retinopathy study.
Measured: At baseline and at week 50.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start31 Jan 2025
- Primary completion22 Dec 2026 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769048
- Sponsor's protocol ID
- 1484-0005
- Other IDs
- U1111-1309-9115
- Status last verified
- Sep 2026
- First submitted
- 7 Jan 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06769048
- Acronym / sponsor ID
- 1484-0005
- Conditions
- Geographic Atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 22 Dec 2026 (estimated)
- Study completion
- 5 Jan 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo-matching BI 1584862 | Placebo comparator | Drug: Placebo-matching BI 1584862 |
| BI 1584862 dose 1 | Experimental | Drug: BI 1584862 |
| BI 1584862 dose 2 | Experimental | Drug: BI 1584862 |
| BI 1584862 dose 3 | Experimental | Drug: BI 1584862 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (16 listed)
- 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:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo-matching BI 1584862Placebo-matching BI 1584862 | Drug | Placebo-matching BI 1584862 |
| BI 1584862BI 1584862 | Drug | BI 1584862 dose 1, BI 1584862 dose 2, BI 1584862 dose 3 |
Primary outcome
Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) over a treatment period of up to 50 weeks (expressed in mm/year) in the study eye
Time frame: Up to week 50.
mm is millimeters.
7 secondary outcomes
Key secondary endpoint: Change from baseline in total attenuation as a percentage of the EZ at the macular area with a thickness of 0 μm up to week 50 assessed by volumetric OCT and EZ mapping in the study eye
Time frame: Up to week 50.
Key secondary endpoint: Slope of change from baseline in square root transformed GA area as measured by OCT over a trial period of up to 50 weeks (expressed in mm/year) in the study eye
Time frame: Up to week 50.
Occurrence of TEAES from drug administration until Week 52
Time frame: Up to week 52.
Change from baseline in partial attenuation as a percentage of the ellipsoid zone (EZ) at the macular area with thickness <20 micrograms (μm) up to week 50 assessed by volumetric optical coherence tomography (OCT) in the study eye
Time frame: Up to week 50.
Change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) at Week 50 (expressed in mm) in the study eye
Time frame: At baseline and at week 50.
Occurrence of BCVA letter loss of ≥15 from baseline in the study eye as measured by standardized ETDRS chart for at least 2 consecutive visits between baseline and up to Week 50
Time frame: Up to week 50.
Change from baseline in best-corrected low luminance visual deficit (LLVD) score as measured in letters by ETDRS chart under low-luminance conditions at Week 50 in the study eye
Time frame: At baseline and at week 50.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Related trials for Geographic Atrophy
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
RecruitingPhase 2/3
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
Geographic Atrophy, Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 1584862 in people with Geographic Atrophy, run by Boehringer Ingelheim at 44 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) over a treatment period of up to 50 weeks (expressed in mm/year) in the study eye (time frame: Up to week 50.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.