Complications associated with intravitreal anti-VEGF therapies are reported inconsistently in the literature, thus limiting an accurate evaluation and comparison of safety between studies. This study aimed to develop a standardized classification system for anti-VEGF ocular complications using the Delphi consensus process. Systematic review and Delphi consensus process. Twenty-five international retinal specialists participated in the Delphi consensus survey. A systematic literature search was conducted to identify complications of intravitreal anti-VEGF agent administration based on randomized controlled trials (RCTs) of anti-VEGF therapy. A comprehensive list of complications was derived from these studies, and this list was subjected to iterative Delphi consensus surveys involving international retinal specialists who voted on inclusion, exclusion, rephrasing, and addition of complications. Furthermore, surveys determined specifiers for the selected complications. This iterative process helped to refine the final classification system. The proportion of retinal specialists who choose to include or exclude complications associated with anti-VEGF administration. After screening 18 229 articles, 130 complications were categorized from 145 included RCTs. Participant consensus via the Delphi method resulted in the inclusion of 91 complications (70%) after 3 rounds. After incorporating further modifications made based on participant suggestions, such as rewording certain phrases and combining similar terms, 24 redundant complications were removed, leaving a total of 67 complications (52%) in the final list. A total of 14 complications (11%) met exclusion thresholds and were eliminated by participants across both rounds. All other remaining complications not meeting inclusion or exclusion thresholds also were excluded from the final classification system after the Delphi process terminated. In addition, 47 of 75 proposed complication specifiers (63%) were included based on participant agreement. Using the Delphi consensus process, a comprehensive, standardized classification system consisting of 67 ocular complications and 47 unique specifiers was established for intravitreal anti-VEGF agents in clinical trials. The adoption of this system in future trials could improve consistency and quality of adverse event reporting, potentially facilitating more accurate risk-benefit analyses. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

中文翻译：

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临床试验中抗 VEGF 药物眼部并发症的国际分类系统


文献中对玻璃体内抗 VEGF 治疗相关并发症的报道不一致，因此限制了研究之间安全性的准确评估和比较。本研究旨在利用德尔菲共识流程开发抗 VEGF 眼部并发症的标准化分类系统。系统审查和德尔菲共识流程。二十五位国际视网膜专家参与了德尔菲共识调查。基于抗 VEGF 治疗的随机对照试验 (RCT)，进行了系统的文献检索，以确定玻璃体内抗 VEGF 药物给药的并发症。这些研究得出了一份全面的并发症清单，该清单经过了德尔菲共识迭代调查，国际视网膜专家对并发症的纳入、排除、改写和添加进行了投票。此外，调查还确定了所选并发症的具体说明。这个迭代过程有助于完善最终的分类系统。选择包括或排除与抗 VEGF 给药相关的并发症的视网膜专家比例。经过筛选 18 229 篇文章后，从 145 篇随机对照试验中对 130 种并发症进行了分类。 3 轮后，参与者通过德尔菲法达成共识，纳入了 91 种并发症 (70%)。在根据参与者的建议进行进一步修改后，例如重新措辞某些短语和组合相似的术语，删除了 24 个多余的并发症，最终列表中总共留下了 67 个并发症（52%）。两轮参与者总共消除了 14 种并发症（11%）。 德尔菲流程终止后，所有其他不符合纳入或排除阈值的剩余并发症也被排除在最终分类系统之外。此外，根据参与者的协议，纳入了 75 个提议的并发症说明中的 47 个（63%）。利用德尔菲共识流程，为临床试验中的玻璃体内抗 VEGF 药物建立了一个全面、标准化的分类系统，由 67 种眼部并发症和 47 种独特的分类系统组成。在未来的试验中采用该系统可以提高不良事件报告的一致性和质量，从而有可能促进更准确的风险效益分析。专有或商业披露可在本文末尾的脚注和披露中找到。