Twelve-Month Outcomes Using Aflibercept 8 mg in Treatment-Naïve and Pretreated Diabetic Macular Edema: A Swiss Retina Research Network Report.

Purpose
To evaluate the effectiveness and safety of intravitreal aflibercept 8 mg (Afl 8) for the therapy of treatment-naïve and pretreated diabetic macular edema (DME) in a clinical routine setting.Design
A multicenter, retrospective cohort study of consecutive DME patients treated with Afl 8 over 12 months.Subjects
One hundred fifty-six eyes (124 patients) with DME, including 42 (26.9%) treatment-naïve and 114 (73.1%) pretreated eyes receiving Afl 8 for 1 year.Methods
Data from electronic medical records were collected retrospectively at 5 predefined time points. The primary outcomes were the mean changes in corrected visual acuity (VA), center-point retinal thickness (CRT), central subfield thickness (CST), treatment intervals, and adverse events (AEs). Secondary outcomes included the number of injections, persistent fluid, and treatment adherence. These parameters were recorded from the beginning of anti-VEGF treatment until switching occurred in pretreated eyes.Main Outcome Measures
Mean change in VA, CRT, CST, treatment intervals, and AEs.Results
In treatment-naïve eyes, VA improved from 72.9 ± 10.7 ETDRS letters at baseline to 77.7 ± 9.7 (P = 0.006); and from 73.9 ± 11.2 to 75.4 ± 10.1 ETDRS letters (P = 0.094) in pretreated eyes. Central subfield thickness decreased in both groups (naïve: 448.9 ± 154.3 μm to 320.0 ± 80.1 μm, P < 0.001; pretreated: 336.6 ± 90.5 μm to 310.2 ± 69.9 μm, P = 0.047). After 12 months, 38.1% of naïve eyes and 27.2% of pretreated eyes were free of retinal fluid in the central 1 mm. In treatment-naïve eyes, the mean treatment interval was 15.3 ± 12.0 weeks at 12 months. In pretreated eyes, the interval increased from 7.6 ± 3.7 weeks at the time of switching to 13.0 ± 9.0 weeks (P < 0.001). Two eyes (4.8%) in the naïve group and 16 eyes (14%) in the switcher group were switched away within the first year due to insufficient response to Afl 8 therapy. No AEs were reported in the treatment-naïve group. In the pretreated group, 3 cases of noninfectious intraocular inflammation (IOI; 1.9%; 1 recurrent), 2 instances of acute intraocular pressure rise, and 1 vitreous hemorrhage were reported.Conclusions
Afl 8 offers a promising approach to reducing the treatment burden in DME. It enables extended dosing intervals without compromising efficacy and safety, especially in refractory eyes. However, a possibly increased rate of mild IOI has been observed.Financial Disclosures
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.