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

Conditions

• Geographic Atrophy
• Macular Degeneration, Age-related

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BI 771716 — DRUG
  BI 771716
• Pegcetacoplan — DRUG
  Pegcetacoplan
• Sham comparator to BI 771716 — DRUG
  Sham comparator to BI 771716

Study Details

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.

Key Dates

Start date

Jan 6, 2025

Status verified

May 2026

Primary completion

Oct 28, 2026

Completion

Oct 28, 2026

Study Design

Enrollment

202 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: BI 771716
• Experimental: Arm B: BI 771716 and Sham comparator
• Active Comparator: Arm C: Pegcetacoplan

Primary Outcome Measure

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 [ Time Frame: At Baseline , at Week 56 ]

Locations (46)

Find similar trials in Gilbert, AZ

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