Monthly or every other month intravitreal pegcetacoplan reported to be tolerated in DERBY and OAKS trials.
Intravitreal pegcetocoplan administered monthly or every other month was observed to be well-tolerated in patients with geographic atrophy (GA) at 12 months, according to new findings presented at the American Society of Retina Specialists 40th Annual Scientific Meeting.
Led by Caroline Baumal MD, Professor, New England Eye Center, Tufts University, investigators reported additional details regarding safety outcomes in the OAKS and DERBY trials. Each evaluated investigational monthly or every-other-month intravitreal pegcetacoplan in eyes with GA secondary to age-related macular degeneration (AMD).
Both of the phase 3 trials evaluated efficacy and safety of pegcetacoplan treatment for GA. Although GA is considered a leading cause of worldwide irreversible vision loss, there is a lack of findings reported on detailed safety data for pegcetacoplan treatment.
Both OAKS and DERBY are randomized, double-masked, sham-controlled trials that enrolled patients ≥60 years old with best-corrected visual acuity (BCVA) ≥24 letters and GA area 2.5 - 17.5 mm2. Primary outcomes were considered the change from baseline to month 12 in GA lesion size measured via fundus autofluorescence in patients treated with pegcetacoplan. Safety outcomes were additionally evaluated, including the incidence of ocular and systemic treatment-emergent adverse events were evaluated.
A total of 6322 pecetacoplan injections were given across each trial at 12 months (safety set: OAKS, n = 636; DERBY, n = 620). The majority of adverse events were considered mild or moderate, according to investigators.
In the OAKS trial, 14 (6.6%), 16 (7.5%), and 8 (3.8%) patients in the monthly, every-other-month, and sham groups, respectively, had adverse events in the study eye related to treatment. In the DERBY trial, 19 (9.2%), 13 (6.3%), and 6 (2.9%) patents in the monthly, every-other-month, and sham groups, respectively have adverse events related to treatment.
Meanwhile, serious ocular adverse events in the study eye were reported for 3 (1.4%), 4 (1.9%), and 0 patients in OAKS and 1 (0.5), 0, and 2 (1.0%) patients in DERBY in the monthly, every-other-month, and sham groups, respectively.
Investigators noted a total of 4 patients discontinued treatment due to ocular adverse events in the study eye in OAKS, including 1 in the monthly group, followed up 2 in the every-other-month group and 1 in the sham group. In Derby, 3 patients discontinued treatment due to ocular adverse events, including 2 in the sham group and 1 in the every-other-month group.
In the combined trials, the investigator-reported events of new onset exudative AMD (eAMD) in the study eye were reported in 25 (6.0%), 17 (4.1%), and 10 (2.4%) patients in the monthly, every-other-month, and sham groups.
The team reported those study eyes that developed eAMD continued treatment with pegcetacoplan and received anti-VEGF therapy. They additionally reported a total of 13 study eyes across both studies receiving pegcetacoplan experienced intraocular inflammation (IOI), with the majority of cases considered mild.
From the 13 study eyes, 10 were able to resume pegcetacoplan without recurrence of IOI. The rate of IOI per injection was 0.22%, according to the data and no cases of vasculitis or occlusive vasculitis were reported.
Moreover, investigators reporting adverse events related to intraocular pressure in the study eye in 8 (3.8%), 10 (4.7%), and 1 (0.5%) patients in OAKS and in 7 (3.4%), 7 (3.4%), and 0 patients in DERBY in the monthly, every-other-month, and sham groups.
“Safety of Intravitreal Pegcetacoplan for Geographic Atrophy: 12-Month Results of the OAKS and DERBY Trials,” was presented at ASRS 2022.
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