BI 1584862 for Age-Related Macular Degeneration

Recruiting at 23 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Must not be taking: IVT treatments, Investigational oral

Disqualifiers: Exudative AMD, Uncontrolled glaucoma, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 50 weeks

138 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have been treated with certain eye injections for less than 12 months, you may need a 4-month break before joining the study.

Eligibility Criteria

Adults aged 55 or older with a specific type of age-related macular degeneration known as geographic atrophy are eligible for this trial. Participants must have their condition confirmed by retinal imaging and be able to commit to the study duration and visits.

Inclusion Criteria

I am a man willing to use contraception or a woman not able to become pregnant.

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.

Exclusion Criteria

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.

Significant disease or other medical conditions 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.

Known hypersensitivity to any of the ingredients used in the investigational medicinal product (IMP) formulation, or any of the medications used.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 1584862 or placebo tablets twice a day for up to 50 weeks

50 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BI 1584862

Trial Overview The trial is testing different doses of BI 1584862, a potential new treatment for geographic atrophy. Participants will be randomly assigned to either receive the actual drug or a placebo that looks identical but contains no medicine, taking tablets twice daily for one year.

Participant Groups

Group I: BI 1584862 dose 3 Experimental Treatment 1 Intervention

Group II: BI 1584862 dose 2 Experimental Treatment 1 Intervention

Group III: BI 1584862 dose 1 Experimental Treatment 1 Intervention

Group IV: Placebo-matching BI 1584862 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+