Characterizing New-Onset Exudation in the Randomized Phase 2 FILLY Trial of Complement Inhibitor Pegcetacoplan for...

Area of Science:

• Ophthalmology
• Retinal Diseases
• Clinical Trials

Background:

• Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD).
• Intravitreal therapies are being investigated to slow GA progression.
• Understanding potential side effects, such as new-onset exudative AMD (eAMD), is crucial.

Purpose of the Study:

• To analyze the clinical characteristics of eyes that developed new-onset exudative AMD (eAMD) during the FILLY trial.
• To identify risk factors associated with the development of eAMD in patients treated with intravitreal pegcetacoplan.

Main Methods:

• Post hoc analysis of a phase 2 study involving 246 patients with GA secondary to AMD.
• Patients received intravitreal pegcetacoplan or sham injections.
• Clinical characteristics, imaging (OCT, FA), and visual acuity were assessed over 18 months.

Main Results:

• Twenty-six eyes (across treatment groups) developed new-onset eAMD.
• A history of eAMD in the fellow eye and the presence of a double-layer sign (DLS) at baseline were significantly associated with eAMD development.
• Development of eAMD did not significantly impact visual acuity and responded to anti-VEGF therapy.

Conclusions:

• Intravitreal pegcetacoplan slowed GA growth but was associated with an increased incidence of eAMD.
• Baseline eAMD in the fellow eye and DLS were predictive of eAMD development.
• The safety profile supported further investigation in phase 3 studies.