BI 1584862 for Age-Related Macular Degeneration

Recruiting at 47 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new medication, BI 1584862, can aid individuals with geographic atrophy, a condition where parts of the retina deteriorate, causing vision loss. The trial aims to determine if the drug can enhance eye health and identify the optimal dose. Participants are divided into four groups, with some receiving varying doses of BI 1584862 and others receiving a placebo (a substance with no active drug). Individuals diagnosed with geographic atrophy in at least one eye may be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to early findings on its efficacy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have tested BI 1584862 for safety in humans. Although detailed information about side effects remains limited, BI 1584862 affects certain bodily processes to aid conditions like geographic atrophy, a serious eye disease.

This trial is in an early stage, focusing on finding the right dose and ensuring safety. While there is some confidence in the treatment's safety, more information is needed. Researchers will closely monitor participants for any health issues, helping to determine how well people can tolerate the treatment.

Consulting a healthcare professional is advisable to understand the possible risks and benefits before deciding to participate. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for age-related macular degeneration, such as anti-VEGF injections like Lucentis and Eylea, BI 1584862 offers a novel approach by potentially targeting different pathways involved in the disease. Researchers are excited about BI 1584862 because it may provide benefits beyond current therapies, potentially improving outcomes for patients who do not fully respond to existing options. Additionally, BI 1584862 is being explored in various dosages, which could help tailor treatments more effectively to individual needs.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Research has shown that BI 1584862 is designed to help people with geographic atrophy, an eye condition. This treatment reduces inflammation and maintains the health of the eye's blood vessels. Early studies suggest it can slow down eye damage in affected individuals. BI 1584862 aims to protect the retina, the part of the eye that detects light, by reducing deteriorating areas. While more research is needed, these early findings offer hope for its effectiveness. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06769048

NCT06769048 | A Study to Test Different Doses of BI ... 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 ...

2. boehringer-ingelheim.com boehringer-ingelheim.com/science-innovation/human-health-innovation/phase-ii-start-oral-treatment-geographic-atrophy

Phase II start of oral treatment for Geographic Atrophy A Study to Test Different Doses of BI 1584862 in People With a Distinct Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/575035

A Study to Test Different Doses of BI 1584862 in People ... 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 ...

4. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/boehringer-geographic-atrophy-trial-first-in-class-therapy

Boehringer Announces Start of Phase II Geographic ... The JADE study will be evaluating BI 1584862, an investigational oral compound that targets inflammation and preserves vascular function.

5. retinalphysician.com retinalphysician.com/issues/2025/march/0325-clinical-trial-update/

Clinical Trial Update March 2025 Purpose: To find out whether BI 1584862 ... outcomes in persistent subretinal eye fluid in neovascular wet age-related macular degeneration.

6. boehringer-ingelheim.com boehringer-ingelheim.com/science-innovation/human-health-innovation/clinical-pipeline/bi-1584862-phospholipid-modulator

BI 1584862: Phospholipid modulator GA is an advanced and severe form of age-related macular degeneration (AMD), a chronic and progressive retinal disease. It can lead to irreversible vision ...

7. drugs.com drugs.com/clinical_trials/boehringer-ingelheim-starts-phase-ii-study-bi-1584862-potential-first-class-oral-compound-22024.html

Boehringer Ingelheim Starts Phase II Study of BI 1584862, ... BI 1584862 is an investigational phospholipid modulator compound intended to limit the further growth of GA by targeting inflammation and preserving vascular ...