Home › Trials › NCT06769048

Testing a new medicine for age-related eye disease

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

Phase 2 Interventional Boehringer Ingelheim · NCT06769048

This study is testing a new medicine to see if it can slow down eye problems in older adults with a specific type of age-related macular degeneration.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment138 (estimated)
Ages55 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations24 sites (Phoenix, Arizona and 23 other locations)
Trial IDNCT06769048 on ClinicalTrials.gov

What this trial studies

This study involves adults aged 55 and older who have been diagnosed with geographic atrophy, a form of age-related macular degeneration. Participants will be randomly assigned to receive either the investigational drug BI 1584862 or a placebo, with the aim of determining the most effective dose. Over the course of one year, participants will attend 13 visits where their eye health will be monitored through imaging techniques and assessments of visual acuity. The study seeks to evaluate the drug's impact on the progression of geographic atrophy.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 55 and older with specific criteria for geographic atrophy related to age-related macular degeneration.

Not a fit: Patients with other forms of macular degeneration or those whose geographic atrophy does not meet the study's specific criteria may not benefit.

Why it matters

Potential benefit: If successful, this treatment could slow or improve the progression of geographic atrophy, potentially preserving vision for patients.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in treating age-related macular degeneration with novel therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 ≥1.25 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 30 or 35 degree 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 ≥55 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.
* Patients who received IVT treatment for GA (pegcetacoplan or avacincaptad pegol) for ≥12 months and/or received ≥6 injections in the study eye. Patients treated for \<12 months who have received \<6 intravitreal (IVT) injections in the study eye may be included after a washout period of at least 4 months between the last injection and randomization.
* Prior or ongoing investigational oral treatment for GA. A washout period of 4 months, or 6 to 7 half-lives, whichever is longer, is acceptable.
* 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 intraocular pressure (IOP) \>24 mmHg, or use of \>2 IOP-lowering medications in the study eye
  * clinically significant diabetic retinopathy or maculopathy
  * history of high myopia, i.e. spherical equivalent of ≥8 diopters or axial length ≥27.2 mm
  * anterior segment and vitreous abnormalities that would preclude adequate observation with Spectral domain - optical coherence tomography (SD-OCT)
  * 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.

Where this trial is running

Phoenix, Arizona and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Geographic Atrophy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.