One-year anti-VEGF therapy outcomes in diabetic macular edema based on treatment intensity: Data from the FRB! registry

Hemal Mehta; Pierre-Henry Gabrielle; Yohei Hashimoto; Getiye Dejenu Kibret; Jennifer Arnold; Tremeur Guillaumie; Wajiha Jurdi Kheir; Gerhard Kok; Stela Vujosevic; Louise O'Toole; Els Mangelschots; Nandor Jaross; Lala Ceklic; Vincent Daien; Francesco Viola; David Squirrell; Francisco Javier Lavid; Catherine Creuzot-Garcher; Daniel Barthelmes; Mark Gillies; Fight Retinal Blindness! Study Group

doi:10.1016/j.oret.2024.04.008

One-year anti-VEGF therapy outcomes in diabetic macular edema based on treatment intensity: Data from the FRB! registry

Ophthalmol Retina. 2024 Apr 12:S2468-6530(24)00182-9. doi: 10.1016/j.oret.2024.04.008. Online ahead of print.

Authors

Hemal Mehta¹, Pierre-Henry Gabrielle², Yohei Hashimoto³, Getiye Dejenu Kibret³, Jennifer Arnold⁴, Tremeur Guillaumie⁵, Wajiha Jurdi Kheir⁶, Gerhard Kok⁷, Stela Vujosevic⁸, Louise O'Toole⁹, Els Mangelschots¹⁰, Nandor Jaross¹¹, Lala Ceklic¹², Vincent Daien¹³, Francesco Viola¹⁴, David Squirrell¹⁵, Francisco Javier Lavid¹⁶, Catherine Creuzot-Garcher¹⁷, Daniel Barthelmes¹⁸, Mark Gillies³; Fight Retinal Blindness! Study Group

Collaborators

Fight Retinal Blindness! Study Group:
Admir Miri, Adrian Fung, Alejandro Higueras, Alessandro Invernizzi, Alex Hamilton, Amy Cohn, Ann Vanderschueren, Benjamin Wolff, Bougamha Walid, Charles Hennings, Charmaine Chung, Chris Hornsby, Cinthia Rethati, Daniel Barthelmes, Daniel Velazquez Villoria, David Squirrell, Derek Chan, Elaine Chong, Els Mangelschots, Ester Carreño, Florian Baudin, Francesco Viola, Francisco Javier Lavid, Gerhard Kok, Graham Furness, Guillaume Michel, Heather Mack, Helen Steiner, Hemal Mehta, Ian Reddie, James Acton, Jane Wells, Jennifer Arnold, Joel Suarez, Jolly Gilhotra, Justin Oday, Lala Ceklic, Laura Sararols, Les Manning, Li Ping Chow, Louise OToole, Luis Cordoves, Maite Arrazola, María Eugenia Tena Sempere, Maria Pilar Navarro, Mark Gillies, Mark Morgan, Marta Rodriguez Núñez, Michel Weber, Miguel Castilla Marti, Miguel de la Fuente, Monica Asencio Duran, Nandor Jaross, Pablo Catalán Muñoz, Pablo Carnota, Patrick Lockie, Paul Beaumont, Peter Hinchcliffe, Pierre-Henry Gabrielle, Pilar Calvo, Rachel Barnes, Raj Chalasani, Richard Barry, Robert Chong, Roberto Gallego-Pinazo, Ross Ferrier, Samantha Fraser-Bell, Sandrine Allieu, Sanjeev Wickremasinghe, Sarah Tick, Sarah Welch, Saturnino Manuel Gismero Moreno, Simon Nothling, Sonia Aparicio-Sanchis, Stela Vujosevic, Stephanie Young, Sue Wan, Terence Tan, Tremeur Guillaumie, Vincent Daien, Wajiha Kheir, Xavier Valldeperas, Zanne Louw, Ziad Bashshur

Affiliations

¹ The University of Sydney, Sydney Medical School, Discipline of Ophthalmology, Save Sight Institute, New South Wales, Australia; Department of Ophthalmology, Royal Free London NHS Foundation Trust, London, United Kingdom.
² The University of Sydney, Sydney Medical School, Discipline of Ophthalmology, Save Sight Institute, New South Wales, Australia; Department of Ophthalmology, Dijon University Hospital, Dijon, France Eye Clinic. Electronic address: phgabrielle@gmail.com.
³ The University of Sydney, Sydney Medical School, Discipline of Ophthalmology, Save Sight Institute, New South Wales, Australia.
⁴ Marsden Eye Specialists, Sydney, New South Wales, Australia.
⁵ Department of Ophthalmology, Saint Brieuc Hospital, 22000 Saint Brieuc, France.
⁶ Department of Ophthalmology, American University of Beirut Medical Center, Beirut, Lebanon.
⁷ Dr. Gerhard Kok Inc. (private ophthalmology practice), Pretoria, South Africa.
⁸ Department of Biomedical, Surgical and Dental Sciences University of Milan, Milan, Italy; Eye Clinic IRCCS MultiMedica, Milan, Italy.
⁹ Mater Private Network, Dublin & University College Dublin, Ireland.
¹⁰ Oogartsenpraktijk Alken and Jessa Ziekenhuis Hasselt, Belgium.
¹¹ Australian Eye Specialists (Wyndham), Werribee, Victoria, Australia.
¹² University of Vitez, Travnik, Bosnia and Herzegovina.
¹³ The University of Sydney, Sydney Medical School, Discipline of Ophthalmology, Save Sight Institute, New South Wales, Australia; Department of Ophthalmology, Gui de Chauliac Hospital, 80 Avenue Augustin Fliche, 34000, Montpellier, France.
¹⁴ Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
¹⁵ Auckland District Health Board, Auckland, New Zealand.
¹⁶ Department of Ophthalmology, Hospital Punta Europa, Algeciras, Cádiz, Spain.
¹⁷ Department of Ophthalmology, Dijon University Hospital, Dijon, France Eye Clinic.
¹⁸ The University of Sydney, Sydney Medical School, Discipline of Ophthalmology, Save Sight Institute, New South Wales, Australia; Department of Ophthalmology, University Hospital Zurich and University of Zurich, Zurich, Switzerland.

PMID: 38615818
DOI: 10.1016/j.oret.2024.04.008

Abstract

Purpose: To compare one-year outcomes of eyes with diabetic macular edema (DME) treated in routine clinical practice based on the proportion of visits where intravitreal vascular endothelial growth factor (VEGF) inhibitor injections were delivered.

Design: Cohort study PARTICIPANTS: There were 2288 treatment-naïve eyes with DME starting intravitreal VEGF inhibitor therapy from 31 October 2015 to 31 October 2021 from the Fight Retinal Blindness! international outcomes registry.

Methods: Eyes were grouped according to the proportion of visits at which an injection was received, Group A with less than the median of 67% (n=1172) versus Group B with greater than the median (n=1116).

Main outcome measure: Mean visual acuity (VA) change after 12 months of treatment.

Results: The mean (95% confidence interval [CI]) VA change after 12 months of treatment was 3.6 (2.8, 4.4) letters for eyes in Group A versus 5.2 (4.4, 5.9) letters for eyes in Group B (p=0.005). The mean (95% CI) central subfield thickness (CST) change was -69 (-76, -61) μm and -85 (-92, -78) μm for eyes in Group A versus Group B, respectively (p=0.002). A moderate positive correlation was observed between the number of injections received over 12 months of treatment and the change in VA (p<0.001). Additionally, eyes that received more injections had a moderately greater CST reduction.

Conclusions: This registry analysis found that overall VA and anatomic outcomes tended to be better in DME eyes treated at a greater proportion of visits in the first year of intravitreal VEGF inhibitor therapy.

Keywords: Diabetic macular edema; Pro-Re-Nata; VEGF inhibitor; anti-VEGF; fixed; proactive; reactive regimen; real-world evidence; registry; treat-and-extend; treatment pattern.