International Classification System for Ocular Complications of Anti-VEGF Agents in Clinical Trials.

Autor:	Popovic MM; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada., Balas M; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada., Sadda SR; Doheny Eye Institute, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California., Sarraf D; Stein Eye Institute, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California., Huang R; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada., Bakri SJ; Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota., Berrocal A; Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Leonard M. Miller School of Medicine, Miami, Florida., Chang A; Sydney Retina Clinic, Sydney Eye Hospital, University of New South Wales, Sydney, Australia., Gemmy Cheung CM; Department of Ophthalmology, National University of Singapore, Singapore, Republic of Singapore., Garg S; Mid Atlantic Retina, The Retina Service of Wills Eye Hospital, Wills Eye Hospital, Philadelphia, Pennsylvania., Hillier RJ; Newcastle Eye Centre, Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom., Holz FG; Department of Ophthalmology, University of Bonn, Bonn, Germany., Johnson MW; Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan., Kaiser PK; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio., Kertes PJ; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada., Lai TYY; Department of Ophthalmology & Visual Sciences, The Chinese University of Hong Kong, Kowloon, Hong Kong, China., Noble J; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada., Park SS; Department of Ophthalmology & Vision Science, University of California Davis Eye Center, Sacramento, California., Paulus YM; Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan., Querques G; Department of Ophthalmology, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy., Rachitskaya A; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio., Ruamviboonsuk P; Department of Ophthalmology, College of Medicine, Rangsit University, Rajavithi Hospital, Bangkok, Thailand., Saidkasimova S; Tennent Institute of Ophthalmology, Glasgow, Scotland, United Kingdom., Sandinha MT; Department of Eye and Visual Science, University of Liverpool, Merseyside, United Kingdom., Steel DH; Sunderland Eye Infirmary, Sunderland, United Kingdom., Terasaki H; Nagoya University Hospital, Nagoya, Japan., Weng CY; Cullen Eye Institute, Baylor College of Medicine, Houston, Texas., Williams BK Jr; Cincinnati Eye Institute, Department of Ophthalmology, University of Cincinnati College of Medicine, Cincinnati, Ohio., Wu L; Department of Ophthalmology, Asociados de Mácula Vitreo y Retina de Costa Rica, San José, Costa Rica., Muni RH; Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada. Electronic address: rajeev.muni@utoronto.ca.
Jazyk:	angličtina
Zdroj:	Ophthalmology [Ophthalmology] 2024 Dec; Vol. 131 (12), pp. 1457-1467. Date of Electronic Publication: 2024 Jun 13.
DOI:	10.1016/j.ophtha.2024.06.011
Abstrakt:	Purpose: 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. Design: Systematic review and Delphi consensus process. Participants: Twenty-five international retinal specialists participated in the Delphi consensus survey. Methods: 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. Main Outcome Measures: The proportion of retinal specialists who choose to include or exclude complications associated with anti-VEGF administration. Results: 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. Conclusions: 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. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. (Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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