BI 771716 for Age-Related Macular Degeneration

(VERDANT Trial)

Not currently recruiting at 58 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Disqualifiers: Exudative AMD, Uncontrolled glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 14

Duration: 56 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, BI 771716 (an experimental treatment), for individuals with geographic atrophy, an eye condition linked to age-related macular degeneration. The study compares BI 771716 to pegcetacoplan, an existing treatment, to determine which is more effective. Participants receive eye injections and attend regular check-ups over a year. The trial seeks individuals aged 50 or older with geographic atrophy affecting daily life, excluding those with certain other eye conditions. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

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 received treatment for geographic atrophy in the past 4 months or participated in a related trial in the past 6 months, you may not be eligible.

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

Research has shown that BI 771716 met its main safety goals in earlier studies, indicating the treatment was generally safe when administered as eye injections. Both single and multiple doses were tested, and patients tolerated them well, with no major safety issues reported.

Pegcetacoplan is already approved for treating geographic atrophy, demonstrating a good safety record. People using pegcetacoplan have not encountered significant safety problems related to the treatment.

In summary, both BI 771716 and pegcetacoplan have demonstrated safety in humans. BI 771716 has passed important safety tests, and pegcetacoplan is already used safely in patients with similar conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for geographic atrophy?

Researchers are excited about BI 771716 for age-related macular degeneration (AMD) because it offers a novel approach compared to current treatments like anti-VEGF therapies, which are the standard of care. Unlike these treatments, which mainly inhibit blood vessel growth, BI 771716 works differently by targeting specific cellular pathways involved in AMD progression. This unique mechanism could potentially address aspects of the disease that existing treatments do not, offering hope for better outcomes. Additionally, the trial includes a comparison with Pegcetacoplan, an active comparator, to evaluate BI 771716's effectiveness and safety against another promising treatment. This comprehensive approach helps ensure that the new treatment could provide a significant advantage over existing options.

What evidence suggests that this trial's treatments could be effective for geographic atrophy?

In this trial, participants will receive either BI 771716 or pegcetacoplan. Earlier studies showed that BI 771716 produced promising results for treating geographic atrophy, a severe form of age-related macular degeneration. This treatment targets specific proteins involved in the disease, potentially slowing or stopping vision loss. Early findings suggested it was well-tolerated and could effectively preserve eye health. Meanwhile, pegcetacoplan has already helped patients with this condition by slowing retinal damage. Both treatments involve eye injections and are being compared in this trial to determine which works better. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for people aged 50 or older with geographic atrophy, an advanced form of age-related macular degeneration (AMD). Participants will be involved in the study for just over a year with monthly visits to the study site.

Inclusion Criteria

I have signed and understand the consent form for this trial.

BCVA letter score of ≥24 letters, using the early trial diabetic retinopathy study (ETDRS) chart in the study eye

I have been diagnosed with geographic atrophy due to AMD, and my lesion size is between 2.5 and 17.5 mm2.

Exclusion Criteria

GA lesions whose area cannot be accurately defined in the study eye

My study eye has wet age-related macular degeneration.

I haven't taken oral or eye injection trial drugs for my eye condition in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BI 771716 or pegcetacoplan as injections in the eye. The study doctor checks the eyes of the participants and monitors health and unwanted effects.

56 weeks

14 visits (in-person, every 4 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 771716

Trial Overview The trial compares two treatments: BI 771716 and pegcetacoplan, both administered as eye injections. The effectiveness of BI 771716 in treating geographic atrophy will be evaluated against pegcetacoplan, which is already used for this condition.

How Is the Trial Designed?

Group I: Arm B: BI 771716 and Sham comparator Experimental Treatment 2 Interventions

Group II: Arm A: BI 771716 Experimental Treatment 1 Intervention

Group III: Arm C: Pegcetacoplan Active Control 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/NCT06722157

NCT06722157 | A Study to Test Whether BI 771716 Helps ... This study is open to people 50 years or older with an eye condition called geographic atrophy. The purpose of this study is to compare a medicine called BI ...

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

Geographic Atrophy treatment to move to Phase II Boehringer Ingelheim and CDR-Life today announce positive results from the Phase I evaluation of BI 771716 (Study Record ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/boehringer-geographic-atrophy-trial/

Boehringer, CDR-Life report data from geographic atrophy ... Boehringer Ingelheim and CDR-Life have reported positive outcomes from the Phase I clinical trial of BI 771716, a new treatment for geographic atrophy (GA).

4. ctv.veeva.com ctv.veeva.com/study/a-study-to-test-whether-bi-771716-helps-people-with-an-advanced-form-of-age-related-macular-degenera

A Study to Test Whether BI 771716 Helps People With an ... This study is open to people 50 years or older with an eye condition called geographic atrophy. The purpose of this study is to compare a ...

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

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

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-test-how-well-different-doses-of-bi-771716-are-tolerated-by-people-with-an-advanced-form

A Study to Test How Well Different Doses of BI 771716 Are ... A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form of Age-related Macular Degeneration (AMD) ...