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

Phase 2

Recruiting

• Conditions: Macular Degeneration, Age-related; Geographic Atrophy
• Interventions: Drug: BI 771716; Drug: Pegcetacoplan; Drug: Sham comparator to BI 771716

• Registration Number: NCT06722157
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-09
• Study Start: 2025-01-06
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-09
• Primary Completion: 2026-12-16
• Study Completion: 2027-02-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: BI 771716	BI 771716	-
Arm B: BI 771716 and Sham comparator	BI 771716	-
Arm B: BI 771716 and Sham comparator	Sham comparator to BI 771716	-
Arm C: Pegcetacoplan	Pegcetacoplan	-

Primary Outcome Measures

Name	Time	Method
Slope of change from baseline in square root transformed geographic atrophy (GA) area as measured by fundus autofluorescence (FAF) in the study eye expressed in millimeter (mm)/year	At Baseline , at Week 56

Secondary Outcome Measures

Name	Time	Method
Change from baseline in square root transformed GA area as measured by FAF in the study eye expressed in mm	At Baseline, at Week 56
Change from baseline in best corrected visual acuity (BCVA) as measured by standardized early trial diabetic retinopathy study (ETDRS) chart in the study eye	At Baseline, at Week 56
Occurrence of BCVA letter loss of ≥15 letters as measured by standardized ETDRS chart in the study eye for at least 2 consecutive visits	Up to Week 56
Occurrence of exudative neovascular age-related macular degeneration (eAMD) in the study eye from first drug administration until Week 56	Up to Week 56
Occurrence of drug-related adverse events (AE) from first drug administration until Week 56	Up to Week 56

Trial Locations

Locations (47)

Associated Retina Consultants; 🇺🇸 Gilbert, Arizona, United States

Associated Retina Consultants, Ltd.; 🇺🇸 Phoenix, Arizona, United States

Phoenix Retina Associates; 🇺🇸 Phoenix, Arizona, United States

Retina Macula Institute of Arizona; 🇺🇸 Scottsdale, Arizona, United States

Global Research Management; 🇺🇸 Glendale, California, United States

Retina Associates of Southern California; 🇺🇸 Huntington Beach, California, United States

Retinal Consultants Medical Group, Inc; 🇺🇸 Modesto, California, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Retina Consultants of San Diego; 🇺🇸 Poway, California, United States

Retinal Consultants Medical Group; 🇺🇸 Sacramento, California, United States

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