Early Outcome of Aflibercept 8 mg for Neovascular AMD in the Real-world Setting.

Purpose: To investigate the early outcome of intravitreal aflibercept 8 mg in treating neovascular age-related macular degeneration (nAMD) of eyes that either received prior intravitreal anti-VEGF treatment or were treatment-naïve - under real-world conditions.

Methods: This is a retrospective study of a total of 83 eyes with nAMD treated with aflibercept 8 mg. 61 of these eyes completed an initial loading phase of 3 monthly intravitreal injections (IVI) and were included in further analyses. Outcome parameters included best-corrected visual acuity (BCVA, logMAR), presence of intraretinal (IRF) and subretinal fluid (SRF), extent of pigment epithelium detachment (PED height, µm) and central subfield retinal thickness (CSRT, µm) in spectral domain optical coherence tomography (SD-OCT). Patients were assessed at the beginning of aflibercept 8 mg treatment and 4 weeks after completing the loading phase. The McNemar test was used to test for changes in distribution of eyes showing IRF and SRF, and the paired t test was performed to test for changes in BCVA, PED height and CSRT.

Results: 51 eyes had been previously treated with intravitreal anti-VEGF, while 10 eyes were treatment-naïve. Mean BCVA after completed loading phase was 0.49 ± 0.31 logMAR and did not show changes to baseline BCVA, which was 0.49 ± 0.32 logMAR (p = 0.89). A significant reduction was observed in all disease activity parameters in SD-OCT. The proportion of eyes showing IRF and SRF decreased from 54.1% to 26.2% (p < 0.001) and 65.6% to 24.6% (p < 0.001), respectively. A reduction in PED height from 227.7 ± 114.6 µm at baseline to 191.9 ± 111.4 µm (p < 0.001) and a decrease in CSRT from 375.2 ± 126.2 µm to 308.8 ± 93.7 (p < 0.001) were recorded. Of all eyes (n = 83) that had received at least one IVI aflibercept 8 mg, 5 eyes (6.0%) developed symptomatic, non-infectious intraocular inflammation (IOI), which resolved completely with topical treatment.

Conclusion: Our results demonstrate good effectiveness of intravitreal aflibercept 8 mg in the real-world setting, with significant reduction in disease activity parameters in SD-OCT after the loading phase with 3 monthly injections - while BCVA remained stable. While the PULSAR trial only included treatment-naïve eyes, our study underlines the value of aflibercept 8 mg, even for pre-treated eyes that responded insufficiently to previous anti-VEGF treatment. Further studies are needed to evaluate long-term outcome in real-world setting, in order to verify the extended IVI intervals shown in the PULSAR trial.