BI 771716 for Age-Related Macular Degeneration

(VERDANT Trial)

Recruiting at 55 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

180 Participants Needed

Trial Summary

What is the purpose of this trial?

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 771716 with a medicine called pegcetacoplan. BI 771716 is being developed to treat people with geographic atrophy. Pegcetacoplan is a medicine already used to treat people with geographic atrophy. In this study, participants receive either BI 771716 or pegcetacoplan as injections in the eye. Participants are in the study for a little longer than a year and visit the study site every 4 weeks. At the visits, the study doctor checks the eyes of the participants. The results are compared between the groups of participants to see whether the treatment works. The study doctor also regularly checks participants' health and takes note of any unwanted effects.

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+