Placebo-matching BI 1584862: Placebo-matching BI 1584862
BI 1584862: BI 1584862
Study 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.
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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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 ≥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
Exclusion criteria:
* 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
* 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.
Primary outcome measure(s)
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 — Up to week 50. mm is millimeters.
Trial sites (44)
Facility
City
Region
Status
Associated Retina Consultants
Gilbert
Arizona
Associated Retina Consultants, Ltd.
Phoenix
Arizona
Cameron Ria, LLC
Phoenix
Arizona
Retina Macula Institute of Arizona
Scottsdale
Arizona
Retina-Vitreous Associates Medical Group
Beverly Hills
California
Global Research Management
Glendale
California
Retina Associates of Southern California
Huntington Beach
California
Retinal Consultants Medical Group, Inc
Modesto
California
Northern California Retina Vitreous Associates MedicalGroup, Inc.
Mountain View
California
Eye Research Foundation
Newport Beach
California
Retina Consultants of San Diego
Poway
California
Retinal Consultants Medical Group
Sacramento
California
Bay Area Retina Associates - Walnut Creek
Walnut Creek
California
Retina Specialists of Colorado Research, LLC
Denver
Colorado
Coastal Eye Surgeons
Greenwich
Connecticut
Vitreo Retinal Associates - Gainesville
Gainesville
Florida
MedEye Associates
Miami
Florida
Eye Associates of Pinellas
Pinellas Park
Florida
East Florida Eye Institute
Stuart
Florida
Center for Retina and Macular Disease
Winter Haven
Florida
Southeast Retina Center, PC
Augusta
Georgia
Illinois Retina Associates - Oak Park
Oak Park
Illinois
The Eye Care Institute
Louisville
Kentucky
Cumberland Valley Retina Consultants
Hagerstown
Maryland
Ophthalmic Consultants of Boston
Boston
Massachusetts
University of Missouri Health System
Columbia
Missouri
NJRetina
Teaneck
New Jersey
Verum Research, LLC
Eugene
Oregon
Retina Northwest
Portland
Oregon
EyeHealth Northwest
Portland
Oregon
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia
Pennsylvania
Charleston Neuroscience Institute - Charleston
Charleston
South Carolina
Tennessee Retina
Nashville
Tennessee
Austin Clinical Research, LLC
Austin
Texas
Retina Consultants of Texas-Beaumont-70319
Beaumont
Texas
Retina Foundation of the Southwest
Dallas
Texas
Red River Research Partners, LLC - Plano
Plano
Texas
Retinal Consultants of San Antonio
San Antonio
Texas
Retina Consultants of Texas - Schertz
Schertz
Texas
Retina Consultants of Texas-The Woodlands-67575
The Woodlands
Texas
+ 4 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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