Trial intelligence / Profile preview

VERDANT Trial: BI 771716 vs Pegcetacoplan in Geographic Atrophy

NCT06722157Phase 2

Key facts

Status
Active, not recruiting
Start
Jan 2025
Primary completion
Oct 2026
Countries
1
Modality
Antibody Fragments, Antibody Conjugates, Monoclonal Antibodies
Conditions
geographic atrophy (GA)
01

Overview

Phase 2, randomised, double-blind trial of BI 771716 in geographic atrophy (GA) (3 arms), sponsored by Boehringer Ingelheim. Primary endpoint: Slope of change from baseline in square root transformed geographic atrophy area at 56 weeks. Started Jan 2025; status: active, not recruiting.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • Arm A: BI 771716

    BI 771716

  • Arm B: BI 771716 and Sham comparator

    BI 771716 and Sham comparator

  • Arm C: Pegcetacoplan

    Pegcetacoplan

03

Who it enrols

Participants must be >=50 years old with geographic atrophy secondary to AMD, total GA lesion area >=2.5 mm2 and <=17.5 mm2, and BCVA >=24 letters.

04

Endpoints

Primary

  • Slope of change from baseline in square root transformed geographic atrophy area

Secondary

  • Change from baseline in square root transformed geographic atrophy area

  • Change from baseline in best corrected visual acuity

  • Occurrence of BCVA letter loss of >=15 letters

  • Occurrence of exudative neovascular age-related macular degeneration

  • Occurrence of drug-related adverse events

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