A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy

Launched by BOEHRINGER INGELHEIM · Jan 7, 2025

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ClinConnect Summary

This clinical trial is studying a medication called BI 1584862 to see if it can help improve vision in adults aged 55 and older who have a specific type of age-related macular degeneration (AMD) known as geographic atrophy. Geographic atrophy causes areas of the retina, which is the part of the eye that senses light, to slowly waste away, leading to vision loss. The trial will involve participants taking either BI 1584862 or a placebo (a non-active pill that looks the same) twice a day for one year. The researchers will closely monitor participants' eye health through regular visits, during which they will take detailed pictures of the back of the eye and assess any changes in the condition.

To join the study, participants must have at least one eye with geographic atrophy that has been confirmed through eye imaging. They should also have a certain level of vision and be in generally good health. Throughout the year, participants will visit the study site 13 times for evaluations, and their experiences will help researchers understand if BI 1584862 is effective in treating this condition. This trial is currently recruiting, so if you or someone you know fits the eligibility criteria, it could be an opportunity to contribute to important research in eye health.

Gender

ALL

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.