Evidence for Whom? A Systematic Review of Eligibility Criteria in RCTs of Anti-VEGF for Neovascular Age-Related Macular Degeneration

Purpose: To summarize the eligibility criteria used in randomized controlled trials (RCT) of intravitreal anti-VEGF treatments for neovascular age-related macular degeneration (AMD). Design: Systematic review. Methods: A search of 12 literature databases was conducted on 15 April 2024. RCTs of intra...

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Main Authors: Andreas Arnold-Vangsted, Emil Alexander Rosenørn, Emilie Theresa Sørrig Butler, Rodrigo Anguita, Rita Serrano Anjos, Lasse Jørgensen Cehofski, Vibeke Christensen, Lorenzo Ferro Desideri, Jakob Grauslund, Javad Nouri Hajari, Musa Yasin Kaya, Oliver Niels Klefter, Celine Lee, Line Petersen, Miklos Schneider, Yousif Subhi
Format: Article
Language:English
Published: Elsevier 2025-07-01
Series:AJO International
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Online Access:http://www.sciencedirect.com/science/article/pii/S2950253525000279
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author Andreas Arnold-Vangsted
Emil Alexander Rosenørn
Emilie Theresa Sørrig Butler
Rodrigo Anguita
Rita Serrano Anjos
Lasse Jørgensen Cehofski
Vibeke Christensen
Lorenzo Ferro Desideri
Jakob Grauslund
Javad Nouri Hajari
Musa Yasin Kaya
Oliver Niels Klefter
Celine Lee
Line Petersen
Miklos Schneider
Yousif Subhi
author_facet Andreas Arnold-Vangsted
Emil Alexander Rosenørn
Emilie Theresa Sørrig Butler
Rodrigo Anguita
Rita Serrano Anjos
Lasse Jørgensen Cehofski
Vibeke Christensen
Lorenzo Ferro Desideri
Jakob Grauslund
Javad Nouri Hajari
Musa Yasin Kaya
Oliver Niels Klefter
Celine Lee
Line Petersen
Miklos Schneider
Yousif Subhi
author_sort Andreas Arnold-Vangsted
collection DOAJ
description Purpose: To summarize the eligibility criteria used in randomized controlled trials (RCT) of intravitreal anti-VEGF treatments for neovascular age-related macular degeneration (AMD). Design: Systematic review. Methods: A search of 12 literature databases was conducted on 15 April 2024. RCTs of intravitreal anti-VEGF for the treatment of neovascular AMD in treatment-naïve eyes were identified. Data on the eligibility criteria for visual function, disease definition and stage, ocular comorbidities, systemic comorbidities, demographics, and other factors not included in other categories were extracted. Results: A total of 49 eligible studies were included in this review, which together included 26,995 eyes of 26,995 patients. We identified a range of eligibility criteria on areas of visual function (minimum 18–50 ETDRS letters; maximum 69–78 ETDRS letters), disease definition and stage (FA only vs. multimodal approach), ocular and systemic comorbidities (most frequent exclusion criteria across studies were any history of the following: intraocular surgery, diabetic retinopathy, panretinal photocoagulation, glaucoma, and myopia), demographics, as well as a miscellaneous category with other topics. Studies employed a set of criteria so stringent that it could be questioned to which extent patients included were generalizable to real-world patients with AMD. Conclusions: RCTs of anti-VEGF treatments for neovascular AMD employ stringent eligibility criteria, which in consequence may reduce the generalizability of findings to real-world populations.
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spelling doaj-art-230268b1a7644e83b57966aff5cee5c42025-08-20T03:19:54ZengElsevierAJO International2950-25352025-07-012210012410.1016/j.ajoint.2025.100124Evidence for Whom? A Systematic Review of Eligibility Criteria in RCTs of Anti-VEGF for Neovascular Age-Related Macular DegenerationAndreas Arnold-Vangsted0Emil Alexander Rosenørn1Emilie Theresa Sørrig Butler2Rodrigo Anguita3Rita Serrano Anjos4Lasse Jørgensen Cehofski5Vibeke Christensen6Lorenzo Ferro Desideri7Jakob Grauslund8Javad Nouri Hajari9Musa Yasin Kaya10Oliver Niels Klefter11Celine Lee12Line Petersen13Miklos Schneider14Yousif Subhi15Department of Ophthalmology, University Hospital of Southern Denmark, Vejle Hospital, Vejle, DenmarkDepartment of Ophthalmology, Hospital Sønderjylland, Sønderborg, DenmarkDepartment of Ophthalmology, Rigshospitalet, Glostrup, DenmarkMoorfields Eye Hospital, NHS Foundation Trust, London, United Kingdom; Department of Ophthalmology, Inselspital, University Hospital Bern, University of Bern, Bern, SwitzerlandDepartment of Ophthalmology, Centro Hospitalar Universitário Lisboa Central, Lisbon, Portugal; Nova Medical School, Lisbon, PortugalDepartment of Ophthalmology, Aalborg University Hospital, Aalborg, DenmarkDepartment of Ophthalmology, Rigshospitalet, Glostrup, DenmarkDepartment for Bio Medical Research, University of Bern, Bern, Switzerland; Bern Photographic Reading Center, Inselspital, University Hospital Bern, Bern, SwitzerlandDepartment of Ophthalmology, Odense University Hospital, Odense, Denmark; Department of Ophthalmology, Vestfold Hospital Trust, Tønsberg, Norway; Department of Clinical Research, University of Southern Denmark, Odense, DenmarkDepartment of Ophthalmology, Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Ophthalmology, Aarhus University Hospital, Aarhus, DenmarkDepartment of Ophthalmology, Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Ophthalmology, Aalborg University Hospital, Aalborg, DenmarkDepartment of Ophthalmology, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus, DenmarkDepartment of Ophthalmology, Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Ophthalmology, Semmelweis University, Budapest, HungaryDepartment of Ophthalmology, Rigshospitalet, Glostrup, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Corresponding author at: Yousif Subhi, Department of Ophthalmology, Rigshospitalet, Valdemar Hansens Vej 13, DK-2600 Glostrup, Denmark.Purpose: To summarize the eligibility criteria used in randomized controlled trials (RCT) of intravitreal anti-VEGF treatments for neovascular age-related macular degeneration (AMD). Design: Systematic review. Methods: A search of 12 literature databases was conducted on 15 April 2024. RCTs of intravitreal anti-VEGF for the treatment of neovascular AMD in treatment-naïve eyes were identified. Data on the eligibility criteria for visual function, disease definition and stage, ocular comorbidities, systemic comorbidities, demographics, and other factors not included in other categories were extracted. Results: A total of 49 eligible studies were included in this review, which together included 26,995 eyes of 26,995 patients. We identified a range of eligibility criteria on areas of visual function (minimum 18–50 ETDRS letters; maximum 69–78 ETDRS letters), disease definition and stage (FA only vs. multimodal approach), ocular and systemic comorbidities (most frequent exclusion criteria across studies were any history of the following: intraocular surgery, diabetic retinopathy, panretinal photocoagulation, glaucoma, and myopia), demographics, as well as a miscellaneous category with other topics. Studies employed a set of criteria so stringent that it could be questioned to which extent patients included were generalizable to real-world patients with AMD. Conclusions: RCTs of anti-VEGF treatments for neovascular AMD employ stringent eligibility criteria, which in consequence may reduce the generalizability of findings to real-world populations.http://www.sciencedirect.com/science/article/pii/S2950253525000279EligibilityExclusion criteriaAnti-VEGFIntravitreal treatmentNeovascular age-related macular degeneration
spellingShingle Andreas Arnold-Vangsted
Emil Alexander Rosenørn
Emilie Theresa Sørrig Butler
Rodrigo Anguita
Rita Serrano Anjos
Lasse Jørgensen Cehofski
Vibeke Christensen
Lorenzo Ferro Desideri
Jakob Grauslund
Javad Nouri Hajari
Musa Yasin Kaya
Oliver Niels Klefter
Celine Lee
Line Petersen
Miklos Schneider
Yousif Subhi
Evidence for Whom? A Systematic Review of Eligibility Criteria in RCTs of Anti-VEGF for Neovascular Age-Related Macular Degeneration
AJO International
Eligibility
Exclusion criteria
Anti-VEGF
Intravitreal treatment
Neovascular age-related macular degeneration
title Evidence for Whom? A Systematic Review of Eligibility Criteria in RCTs of Anti-VEGF for Neovascular Age-Related Macular Degeneration
title_full Evidence for Whom? A Systematic Review of Eligibility Criteria in RCTs of Anti-VEGF for Neovascular Age-Related Macular Degeneration
title_fullStr Evidence for Whom? A Systematic Review of Eligibility Criteria in RCTs of Anti-VEGF for Neovascular Age-Related Macular Degeneration
title_full_unstemmed Evidence for Whom? A Systematic Review of Eligibility Criteria in RCTs of Anti-VEGF for Neovascular Age-Related Macular Degeneration
title_short Evidence for Whom? A Systematic Review of Eligibility Criteria in RCTs of Anti-VEGF for Neovascular Age-Related Macular Degeneration
title_sort evidence for whom a systematic review of eligibility criteria in rcts of anti vegf for neovascular age related macular degeneration
topic Eligibility
Exclusion criteria
Anti-VEGF
Intravitreal treatment
Neovascular age-related macular degeneration
url http://www.sciencedirect.com/science/article/pii/S2950253525000279
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