TRIALS

GALE: evaluation of the long-term safety and efficacy of pegcetacoplan in patients with GA secondary to AMD

STATUS:

Pausat

DESCRIPTION

This is a Phase III, open-label, multicenter clinical trial evaluating the long-term safety and efficacy of intravitreal pegcetacoplan in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Objectives

The primary objective of this study is to evaluate the long-term safety of intravitreal pegcetacoplan, as well as lesion changes measured by autofluorescence.

Drug

FARMAC:

Biochemical, genetic, and clinical evidence in humans indicates that the complement system plays a role in the etiology of AMD.

Complement protein C3 (which has a pro-inflammatory action), the membrane attack complex, and complement factor H are present in drusen and basal laminar deposits in patients with AMD.

Pegcetacoplan is an intravitreal drug that blocks the action of C3. Its main effect is anti-inflammatory.

Population

This study only includes patients who have participated in the APL2-103 study or have completed month 24 of treatment in the APL2-303 (DERBY) or APL2-304 (OAKS) studies.

Duration

La durada de l’assaig és de 3 anys.

Associated Pathologies

No results found.

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Última modificació: 01/09/2025
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