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

Boehringer Ingelheim

Status and phase: Not yet enrolling; Phase 2

Conditions: Geographic Atrophy

Treatments: Drug: BI 1584862; Drug: Placebo-matching BI 1584862

Study type: Interventional

Funder types: Industry

Identifiers

NCT06769048

1484-0005

U1111-1309-9115 (Registry Identifier)

Details and patient eligibility

About

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. All participants take tablets twice a day. Placebo tablets look like BI 1584862 tablets but do not contain any medicine.

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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138 participants in 4 patient groups, including a placebo group

Placebo-matching BI 1584862

Placebo Comparator group

Treatment:

Drug: Placebo-matching BI 1584862

BI 1584862 dose 1

Experimental group

Treatment:

Drug: BI 1584862

BI 1584862 dose 2

Experimental group

Treatment:

Drug: BI 1584862

BI 1584862 dose 3

Experimental group

Treatment:

Drug: BI 1584862