COMPARISON OF CLINICAL AND REAL-LIFE TRIALS OF THE EFFECTIVENESS OF ANTI-VEGF THERAPY FOR AGE-RELATED MACULAR DEGENERATION

Author: Budzinskaya M.V.¹, Plyukhova A.A.², Shelankova A.V.³, Kuznetsov A.V.⁴, Andreeva I.V.⁵

Abstract

In recent years, the approaches to assessing results have been changed in both clinical and real life trials with the introduction of Aflibercept to clinical practice. In most countries, ranibizumab and aflibercept are licensed for the treatment of neovascular age-related macular degeneration (AMD). The assessment of the treatment effectiveness and economic cost was carried out within the frame of different clinical trials with existing strict limitations. The article reviews the results of studies conducted in various clinical trials. Data on long-term follow-up after anti-VEGF therapy for neovascular AMD form, especially in real-life studies, are limited. In the framework of the HORIZON study, representing an extended four-year follow-up of ANCHOR and MARINA patients, the gradual reduction in visual acuity has been revealed in the first 2 years of follow-up period. The re-examination of 10 % of patients from the initial ANCHOR and MARINA studies has been described in the SEVEN-UP study; herewith the decrement in visual activity has been detected after 7 years on the beginning of the clinical studies examination (loss of 8.6 letters against initial letter). The data obtained can not be directly transmitted into routine clinical practice, due to the patients’ inclusion and exclusion Criterion presence, protocols for the introduction of drugs, etc. A study of the therapy’s effectiveness and economic cost in real time allows optimizing the treatment of patients with neovascular AMD.

Key words

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About Authors (Correspondence):

Budzinskaya M.V. – doctor of medical sciences, head of clinical research in ophthalmology department, deputy director on the scientific work, e-mail: m_budzinskaya@mail.ru

Full Text

snmzh_5-2018_budzinskaya_i_dr_102-107.pdf

Received: 29/10/2018

Accepted: 29/10/2018