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

04/12/2022

Description

Its'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).

Goal

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

Drug

Biochemical, genetic and clinical lines of evidence in humans indicate that the complement system plays a role in the aetiology of AMD. Complement protein C3 (which has a pro-inflammatory action), membrane attack complex and complement factor H are present in the drusen and basal laminar deposits of patients with AMD. Pegcetacoplan is a drug for intravitreal use that blocks the action of C3. The main action is anti-inflammatory.

Inclusion criteria

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

Duration

The duration of the trial is three years.