Clinical trial NCT06769048: A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Geographic Atrophy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-01-10
Enrollment: 138
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is open to adults aged 55 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) 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.


Eligibility 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.

Primary outcomes:
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
timeFrame: Up to week 50.
Secondary outcomes:
measure: 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
timeFrame: Up to week 50.
measure: Key secondary endpoint: Slope of change from baseline in square root transformed cRORA (GA) area as measured by OCT over a trial period of up to 50 weeks (expressed in mm/year) in the study eye
timeFrame: Up to week 50.
measure: Occurrence of TEAES from drug administration until Week 52
timeFrame: Up to week 52.
measure: 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
timeFrame: Up to week 50.
measure: 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
timeFrame: At baseline and at week 50.
measure: 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
timeFrame: Up to week 50.
measure: 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
timeFrame: At baseline and at week 50.
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Associated Retina Consultants
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Retina Associates
state: Arizona
city: Scottsdale
country: United States
facility: Retina Macula Institute of Arizona
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Modesto
country: United States
facility: Retinal Consultants Medical Group, Inc
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates MedicalGroup, Inc.
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Poway
country: United States
facility: Retina Consultants of San Diego
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates - Walnut Creek
state: California
city: Denver
country: United States
facility: Retina Specialists of Colorado Research, LLC
state: Colorado
city: Greenwich
country: United States
facility: Coastal Eye Surgeons
state: Connecticut
city: Gainesville
country: United States
facility: Vitreo Retinal Associates - Gainesville
state: Florida
city: Miami
country: United States
facility: MedEye Associates
state: Florida
city: Pinellas Park
country: United States
facility: Eye Associates of Pinellas
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, PC
state: Georgia
city: Oak Park
country: United States
facility: Illinois Retina Associates - Oak Park
state: Illinois
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants, PC.
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri Health System
state: Missouri
city: Teaneck
country: United States
facility: NJRetina
state: New Jersey
city: Eugene
country: United States
facility: Verum Research, LLC
state: Oregon
city: Portland
country: United States
facility: Retina Northwest
state: Oregon
city: Portland
country: United States
facility: EyeHealth Northwest
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Neuroscience Institute - Charleston
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
city: Austin
country: United States
facility: Austin Clinical Research, LLC
state: Texas
city: Beaumont
country: United States
facility: Retina Consultants of Texas-Beaumont-70319
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Plano
country: United States
facility: Red River Research Partners, LLC
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
city: Schertz
country: United States
facility: Retina Consultants of Texas - Schertz
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas-The Woodlands-67575
state: Texas
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute
state: Virginia
city: Lynchburg
country: United States
facility: Piedmont Eye Center
state: Virginia
city: Bellevue
country: United States
facility: Pacific Northwest Retina
state: Washington
city: Arecibo
country: Puerto Rico
facility: Emanuelli Research & Development Center
Study officials:
References: