Eyes that Do Not Meet the Eligibility Criteria of Clinical Trials on Age-Related Macular Degeneration: Proportion of the Real-World Patient Population and Reasons for Exclusion

作者: Jong Woo Kim , Chul Gu Kim , Jae Hui Kim

DOI: 10.1155/2021/6635467

关键词:

摘要: Background. To evaluate the proportion of eyes that do not meet eligibility criteria clinical trials on neovascular age-related macular degeneration (AMD) and reasons for exclusion. Methods. This retrospective, observational study included 512 463 patients diagnosed with treatment-naive AMD. The did Vascular Endothelial Growth Factor Trap-Eye: Investigation Efficacy Safety in Wet AMD (VIEW) studies were evaluated. two most common exclusion also evaluated each subtype (typical AMD, polypoidal choroidal vasculopathy (PCV), type 3 neovascularization). Results. Among eyes, 229 (44.7%) criteria. In all good or poor visual acuity (169 33.0%), followed by presence subretinal hemorrhage (47 9.5%). Moreover, was reason three subtypes second a fovea-involving scar fibrosis typical PCV, other vascular diseases affecting retina neovascularization. Conclusions. cases, 44.7% VIEW study, suggesting conclusion derived from may directly reflect real-world outcomes. Additionally, ineligibility differed among different

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