Baseline Characteristics, Lesion Progression, and Phase 2 FILLY Results
JULY 29, 2019
Eleonora Lad, MD, PhD
“Generally, APL-2 administration resulted in significant decrease in GA progression regardless of gender, age subgroups, and baseline lesion sizes,” said Eleonora Lad, MD, PhD, associate professor of ophthalmology, who presented the post-hoc analysis at ESRS 2019.
The FILLY trial was a phase 2 multi center, randomized, single-masked, sham-controlled clinical trial of APL-2 that involved 246 patients with GA. In order to investigate the impact of specific baseline characteristics on the progression of GA in eyes receiving treatment with APL-2 or sham.
Patients in the study were administered intravitreal injections of APL-2, which inhibits the point of conversion of the compliment pathways, in the study eye monthly or every other month (EOM) for 12 months.
The primary efficacy endpoint for the study was the change in GA lesion size from baseline to the 12-month mark compared to sham treatment. The effect of gender, baseline GA lesion size, and lesion type — whether univocal or multifocal — on mean change in GA lesion size at month 12 was analyzed and the post-hoc was presented at ESRS 2019.
Lad reported that APL-2 administration, generally, resulted in significant decreases in GA progression regardless of the gender or age subgroups and baseline GA sizes. Treatment with APL-2 trended towards being more effective in controlling GA progression with increasing baseline lesion size in a non-linear manner.
Among female patients, the mean change in GA lesion at 12 months was 1.63 (1.78) mm2 in the APL-2 EOM group and 1.48 (0.95) in the APL-2 monthly group compared to 2.48 (1.63) mm2 in the sham arm. Among male patients, those number were 1.64 (1.27) mm2, 1.42 (1.07) mm2, and 1.67 (1.09) mm2, respectively.
Among patients with a lesion size of less than 4.5 mm2, the mean change was 1.15 (0.81) mm2 in the APL-2 monthly group, 1.08 (1.40) mm2 in the APL-2 EOM group, and 1.44 (0.70) in the sham group. In those with a lesion size equal or greater than 4.5 mm2, but less than 7.5 mm2, the mean change was 1.19 (0.91) mm2 among patients in the APL-2 monthly group, 1.45 (0.99) mm2 in the APL-2 EOM group, and 1.83 (1.33) in the sham group.
In the group of patients with a lesion between 7.5 and 10.5 mm2, the mean change was 2.19 (1.02) mm2 in the APL-2 monthly group, 2.91 (2.73) mm2 in the APL-2 EOM group, and 2.68 (1.37) mm2 in patients in the sham group. In patients with a lesion size of 10.5 mm2 or greater, the mean change was 1.5 (0.96) mm2 in the APL-2 monthly group, 1.56 (1.25) mm2 in the APL-2 EOM group, and 2.75 (1.81) mm2 in the sham group.
This study, titled “Evaluation of Baseline Characteristics on Lesion Progression in a Large Phase 2 Clinical Trial for Geographic Atrophy (FILLY Study),” was presented at ESRS 2019.