Visual and anatomic outcomes of aflibercept treatment in treatment-naive patients with neovascular age-related macular degeneration; real-life data over 24 months.

PURPOSE: The aim of this study is to evaluate the 2-year visual and anatomic results of treatment with intravitreal injections of aflibercept in newly diagnosed, treatment-naive patients with neovascular age-related macular degeneration in routine clinical practice of a tertiary hospital of Southwestern Greece. METHODS: In this retrospective, single-center, non-randomized case-series study we analyzed the records of 32 treatment-naive eyes of 28 patients treated with intravitreal injections of aflibercept. Patients received treatment in the Department of Ophthalmology of the University Hospital of Patras from January 2017 to August 2019. The scheduled treatment regimen included a loading dose of 3 consecutive monthly injections of aflibercept and then injections at 8-week intervals for the next 9 months followed by a treat and extend treatment during the second year. Data such as age, gender, best corrected visual acuity (BCVA) and number of injections were recorded. Spectral domain optical coherence tomography (SD-OCT) findings including presence or absence of fluid and automated central macular thickness measurement at baseline, 12 and 24 months were also recorded. RESULTS: The mean age of the patients (14 male, 14 female) was 78.5±7.73 years. Over a period of 12 months, and after a median number of 6 visits (range 3-10), patients received a median number of 6 intravitreal injections of aflibercept (range 3-8). Twenty eyes completed 2 years of treatment with aflibercept. Over the 2-year period patients conducted a median of 14 visits (range 9-15) and received a median number of 10 IVAs (range 6-13). The median logMAR BCVA at 12 months was significantly better compared to baseline [0.412 (range 0.046-1.097) versus 0.549 (range 0-1.301) respectively; p=0.003] while median logMAR BCVA at 24 months [0.398 (range 0.222-1.097)] did not differ significantly compared to baseline (p=0.295). The central macular thickness at baseline was 398.75±98.16 µm and decreased statistically significantly at 12 (295.81±80.48 µm) and 24 months (289.29±34.25 µm) compared to baseline (p=0.0002 and p=0.002, respectively). At baseline SD-OCT examination subretinal fluid (SRF) was present in 26 eyes (81.25%), intraretinal fluid (IRF) was present in 20 eyes (62.5%) while pigment epithelium detachment (PED) was observed in 28 eyes (87.5%) At 12 months SRF was present in 16 eyes (50%), IRF was present in 10 eyes (31.25%) while PED was observed in 23 eyes (71.88%). At 24 months examination SRF was present in 4 eyes (20%), IRF was present in 10 eyes (50%) while PED was observed in 14 eyes (70%). No serious adverse events occurred during this period. CONCLUSION: Treatment with intravitreal injections of aflibercept in a real life setting resulted in a significant improvement in BCVA at 12 months and in a significant anatomic restoration throughout the 24-month follow-up.

Functional and anatomic results of up to 24 months aflibercept treatment for diabetic macular edema in real-life setting.

PURPOSE: Treatment with intravitreal injections of anti-vascular endothelial growth factors, like aflibercept, has revolutionized the management of diabetic macular edema. The purpose of this study is to evaluate the 2-year results of treatment with aflibercept in newly diagnosed, treatment-naive patients with diabetic macular edema in a real-life setting in a tertiary hospital of Southwestern Greece. METHODS: In this retrospective, real-life, single-center, cohort study the records of diabetic patients were reviewed. In the study we included treatment naive eyes that started treatment with intravitreal injections of aflibercept in the Department of Ophthalmology of the University Hospital of Patras. The scheduled treatment regimen of aflibercept was based on the Summary of Product Characteristics of the product and included a loading dose of 5 monthly aflibercept injections followed by bimonthly treatment until the completion of the first year. During the second year a treat and extend treatment regimen was applied. We recorded data such as age, gender, number of visits and injections, best corrected visual acuity (BCVA) and central macular thickness (CMT) as it was evaluated by a spectral domain optical coherence tomography (SD-OCT). RESULTS: Thirty treatment-naive eyes of 22 patients (14 male, 8 female) received treatment with aflibercept for at least 1 year during the period between January 2017 and August 2019. The mean age of the patients was 68.64±7.35 years. Ninety percent of the patients suffered from type-II diabetes and 9% from type-I. The median time between the diagnosis of diabetic macular edema and initiation of treatment with intravitreal injections of aflibercept was 0.5 months (range 0-3 months). Median baseline logMAR BCVA was 0.398 (range 0.046-1.301). The mean CMT at baseline was 388.0±162.94µm. Over a period of 12 months, and after a mean number of 7.5±2.3 visits, patients received a mean number of 7±1.12 intravitreal injections of aflibercept. Eighteen eyes (60%) received an induction phase with 5 monthly injections according to aflibercept SPC. After 12 months the median BCVA (0.324, range 0.0-1.3) was statistically significantly better compared to baseline (p=0.024) and the CMT (295.67±70.99) was significantly lower compared to baseline (p=0.017). Eighteen eyes (60%) completed 2 years of treatment with aflibercept. Over the 2-year period patients made a mean number of 12.7±3.08 visits and received a mean number of 10.2±1.64 intravitreal injections of aflibercept. The median logMAR BCVA at 2 years (0.301, range 0-0.52) was statistically significantly better compared to baseline (p=0.013) and the CMT (293.53±65.93) was significantly lower compared to baseline (p=0.01). No serious adverse events were recorded during this period. CONCLUSION: Aflibercept resulted in significant functional and anatomic improvement after 12- and 24-month treatment in diabetic macular edema eyes in a real-life setting. The majority of the eyes completed the 2-year treatment regimen of aflibercept.