BI 771716 for Age-Related Macular Degeneration (VERDANT Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Prior Safety Data

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.

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

I am 50 years old or older.

I am using or willing to use effective birth control.

Exclusion Criteria

My study eye has wet age-related macular degeneration.

My eye pressure is over 24 mmHg and my glaucoma or eye hypertension is not controlled.

I currently have an eye infection.

I have had vitrectomy surgery in my eye being studied.

I have active inflammation in my eye.

I haven't had eye treatment for GA due to AMD in the last 4 months or 5 half-lives.

I have had gene or cell therapy before.

I have another eye condition that could affect my vision.

I have had major eye surgery.

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

Treatment Details

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.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm B: BI 771716 and Sham comparatorExperimental Treatment2 Interventions

Group II: Arm A: BI 771716Experimental Treatment1 Intervention

Group III: Arm C: PegcetacoplanActive Control1 Intervention