EFFECTIVENESS AND SAFETY OF BROLUCIZUMAB IN TREATING DIABETIC MACULAR EDEMA
Keywords:
Diabetic Macular Edema (DME), Vascular Endothelial Growth Factor (VEGF), Brolucizumab, Aflibercept, Intravitreal Injection, Visual Acuity ImprovementAbstract
While current treatments targeting vascular endothelial growth factor (VEGF) show effectiveness, there's still a call for more therapeutic options that can either enhance treatment outcomes or lessen the need for frequent injections and monitoring in diabetic macular edema (DME) patients. This study aims to assess the performance and safety of brolucizumab compared to aflibercept, administered every four weeks to individuals with DME. Conducted over 52 weeks and double-blinded, this phase 3 trial included adults new to treatment and those who had previously undergone anti-VEGF therapy, with data collection from September 2019 to March 2020 and analysis from April 2020 to February 2021. The intervention involved administering 6 mg of brolucizumab or 2 mg of aflibercept via intravitreal injection every four weeks. Participants were assigned in a 2:1 ratio to either treatment, focusing on primary outcomes like the change in best-corrected visual acuity by week 52, and secondary outcomes including improvements in the Diabetic Retinopathy Severity Scale score, absence of subretinal and intraretinal fluid, changes in central subfield thickness, and overall safety. The trial randomized 217 participants, with a majority being male and an average age of 60.7 years. Brolucizumab showed comparable efficacy to aflibercept regarding visual acuity improvement and demonstrated superiority in reducing subretinal and intraretinal fluid and central subfield thickness. The occurrence of intraocular inflammation, retinal vasculitis, and vascular occlusion was slightly higher in the brolucizumab group, with one case of retinal artery occlusion. Ultimately, the study found no significant difference in visual outcomes between the two treatments, though brolucizumab exhibited certain anatomical advantages without raising new safety issues.
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Статья поступила в редакцию 05.03.2024; одобрена после рецензирования 20.04.2024; принята к публикации 26.04.2024.
The article was submitted 05.03.2024; approved after reviewing 20.04.2024; accepted for publication 26.04.2024.
Информация об авторах:
Хамидуллаев Фирдавс Фаридунович - ассистент кафедры ФПДО Травматологии-ортопедии, нейрохирургии и офтальмологии Самаркандского государственного университета, Самаркандский государственный медицинский университет, Самарканд, Узбекистан. Е-mail: firdavsfaridunovich@gmail.com, https://orcid.org/0009-0000-1652-6988
Норматова Наргиза Миршавкатовна . - доктор медицинских наук, доцент кафедры Офтальмологии, Центр развития профессиональной квалификации медицинских работников при Министерстве здравоохранения Республики Узбекистан,normatovanargiza07@gmail.com, +998931805070, https://orcid.org/0009-0008-0158-5529
Нематуллоев Тухтасин Комилжонович – ассистент кафедры Анестезиологии, реанимации и неотложной помощи Самаркандского государственного университета, Самаркандский государственный медицинский университет, Самарканд, Узбекистан. Е-mail: boboshercc@gmail.com, https://orcid.org/ 0000-0002-6987-7519
Источники финансирования: Работа не имела специального финансирования.
Конфликт интересов: Авторы декларируют отсутствие явных и потенциальных конфликтов интересов, связанных с публикацией настоящей статьи.
Вклад авторов:
Нематуллоев Т.К. — идеологическая концепция работы, написание текста; редактирование статьи;
Хамидуллаев Ф.Ф., Норматова Н.М..— сбор и анализ источников литературы, написание текста.
Information about the authors:
Khamidullaev Firdavs Faridovich Assistant Professor at the Department of Traumatology orthopedics, neurosurgery and ophthalmology of Samarkand State University, Samarkand State Medical University, Samarkand, Uzbekistan. E-mail: firdavsfaridovich@gmail.com, https://orcid.org/0009-0000-1652-6988
Normatova Nargiza Mirshavkatovna - Doctor of Medical Sciences, Associate Professor, Department of Ophthalmology, Center for Professional Development of Healthcare Workers under the Ministry of Health of the Republic of Uzbekistan. Email: normatovanargiza07@gmail.com, ORCID: https://orcid.org/0009-0008-0158-5529
Nematulloev Tuhtasin Komiljonovich - Assistant Professor at the Department of Anesthesiology, Reanimation, and Emergency Medicine of Samarkand State University, Samarkand State Medical University, Samarkand, Uzbekistan. E-mail: boboshercc@gmail.com, https://orcid.org/0000-0002-6987-7519
Sources of funding: The work did not receive any specific funding.
Conflict of interest: The authors declare no explicit or potential conflicts of interest associated with the publication of this article.
Contribution of the authors:
Nematullaev T.K. — ideological concept of the work, writing the text; editing the article;
Khamidullaev F.F., Normatova N.M. — collection and analysis of literature sources, writing the text.
