Results from a phase 2, randomized, single-masked clinical trial found that the overall safety of 8 mg intravitreal aflibercept injection (IAI) in patients with neovascular age-related macular degeneration (nAMD) is similar to IAI 2 mg at Week 16, with observed anatomic and functional improvements.
A total of 106 patients with treatment-naïve active subfoveal choroidal neovascularization secondary to nAMD and a best corrected visual acuity (BCVA) of 78 to 24 letters in the study eye, were randomized 1:1 to receive 3 monthly doses of either IAI 2 mg or IAI 8 mg followed by doses at Week 20 and 32. Overall, mean (SD) baseline BCVA was 58.0 (12.1) letters.
In patients receiving IAI 8 mg, the incidence of ocular-related adverse events (AEs) through Week 16 was 17% compared with 22% in those receiving IAI 2 mg. No new safety signals were identified.
At Week 16, the proportion of eyes with no retinal fluid in the center subfield was 50.9% and 34% in patients receiving IAI 8 mg and IAI 2 mg, respectively. There was also a greater reduction from baseline in median central subfield thickness and a higher increase from baseline in mean BCVA at Week 16 in the IAI 8 mg group.
Through Week 44, no vascular occlusive events occurred, and no patients had an IOP increase of clinical concern. In each group, there was a single case of worsening hypertension control and 1 patient died from glioblastoma in the IAI 8 mg group. There were no reported anti-platelet trialists’ collaboration-defined arterial thromboembolic events.
Reference
Clark W. Evaluation of 8 mg Intravitreal Aflibercept Injection for Neovascular Age-Related Macular Degeneration: Results from the Phase 2 CANDELA Study. Presented at: ASRS 2022.
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