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Monoclonal Antibodies

A Study to Test Whether BI 771716 Helps People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy (VERDANT Trial)

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age at least 50 years old at the time of randomization visit
* Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort or inflammation at the injection site in the eye, vision changes, increased risk of eye infection, and possible allergic reactions to components of either treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 771716
2023
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,552 Previous Clinical Trials
15,858,017 Total Patients Enrolled
~120 spots leftby Dec 2026