研究目的
Evaluating the efficacy of intravitreal aflibercept injection (IAI) in subjects previously treated with ranibizumab and/or bevacizumab for neovascular age-related macular degeneration (AMD).
研究成果
Fixed IAI dosing regimen for 12 months demonstrated improved anatomic and vision endpoints in subjects with active exudative AMD. All subjects were considered visually stable, and the majority had either stable or improved anatomical OCT findings.
研究不足
Small sample size (n=26) and only 12 months of follow-up.
1:Experimental Design and Method Selection:
A prospective, single-arm, investigator-initiated study evaluating the efficacy, safety, and tolerability of intravitreal aflibercept injection in subjects with exudative AMD previously treated with ranibizumab or bevacizumab. Subjects were given monthly 2 mg of IAI for 3 months, followed by 2 mg once every 2 months for up to 12 months.
2:Sample Selection and Data Sources:
Subjects (n=26) with active subfoveal choroidal neovascularization secondary to exudative AMD confirmed by fluorescein angiography, E-ETDRS vision of 25–80 letters, and at least one prior injection of bevacizumab or ranibizumab within 3 months of enrollment.
3:List of Experimental Equipment and Materials:
Intravitreal aflibercept (Eylea; Regeneron Pharmaceuticals, Inc.), optical coherence tomography (Cirrus SDOCT; Humphrey Zeiss, Inc.), E-ETDRS chart (M&S Systems).
4:Experimental Procedures and Operational Workflow:
Subjects were evaluated every month for the first 3 months, and then every 2 months thereafter until month
5:Assessments included BCVA, comprehensive eye examination, and spectral domain OCT scanning. Data Analysis Methods:
Measures were summarized using means, standard deviations, median, and range. Comparisons were performed using two-sided paired t-tests. Analyses were performed using SAS software version 9.2.
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