The earliest approach, a fixed reduction to injections of ranibizumab every 3 months, resulted in the loss of initial VA improvement and was shown to be significantly inferior to monthly injections, although a subset of patients did well on this regimen. Soon after the introduction of anti-VEGF treatment for nAMD, alternative retreatment regimens were explored in order to reduce the treatment burden. 4 In addition, the incidence of nAMD is growing, and the increase in life expectancy is expected to contribute further to this problem. However, this high treatment frequency placed a heavy burden on the management of patients with chronic nAMD, thereby requiring many clinical and therapeutic interventions over the course of the patient's lifespan due to the repetitive treatment scheme and the inability to “cure” the disease. This overwhelming improvement in the prognosis of nAMD was achieved on the basis of monthly injections. The pivotal trials, the “Minimally classic/occult trial of the anti-VEGF antibody ranibizumab in the treatment of neovascular age-related macular degeneration” 1 and the “Anti-VEGF antibody for the treatment of predominantly classic choroidal neovascularization in age-related macular degeneration” 1 were two multicenter, randomized, controlled, phase 3 clinical trials in which the efficacy of monthly intravitreal injections of the anti-VEGF ranibizumab was shown to significantly improve visual acuity (VA) compared with sham treatment 2 or photodynamic therapy 3 in patients with nAMD. One of the major breakthroughs in the management of AMD was the introduction of antivascular endothelial growth factor (anti-VEGF) treatment for neovascular AMD (nAMD). Major scientific advancements have recently been made in the management of age-related macular degeneration (AMD), one of the most frequent macular pathologies, and AMD has been the focus of numerous genetic, histologic, pathogenic, ocular imaging, and therapeutic studies. The related scientific procedure includes the exploration of the concept, evaluation of security, and finally proof of efficacy. The article discusses this translational process which– although not the classical interpretation of translation from fundamental to clinical research, but a subsequent process after the pivotal clinical trials – represents an important translational step from the clinical proof of efficacy to optimization in terms of patients' and clinics' needs. Translational Relevance: This perspective reviews the process from the pivotal clinical trials to the development of treatment regimens which are adjusted to real life requirements. The Observe-and-Plan regimen achieves this goal with good functional results. This includes an individualized treatment approach, optimization of the number of retreatments, a minimal number of monitoring visits, and ease of planning ahead. This progressive development of variable dosing regimens is a response to the real-life circumstances of limited human, technical, and financial resources. Studies investigating the observe-and-plan regimen also showed that this could be used in individualized fixed treatment plans, allowing for dramatically reduced clinical burden and good outcomes, thus meeting the real life requirements. The parallel development of the Observe-and-Plan regimen demonstrated that the future need for retreatment (interval) could be reliably predicted. The Treat-and-Extend regimen uses an interval based approach and has become widely accepted for its ease of preplanning and the reduced number of office visits required. Moreover, application of the PRN regimen revealed inferior results in real-life circumstances due to problems with resource allocation. The PRN regimen showed good visual results but requires monthly monitoring visits and can therefore be difficult to implement. After the initial pivotal trials of anti-VEGF therapy, the variable dosing regimens pro re nata (PRN), Treat-and-Extend, and Observe-and-Plan, a recently introduced regimen, aimed to optimize the anti-VEGF treatment strategy for nAMD. This Perspective discusses the pertinence of variable dosing regimens with anti-vascular endothelial growth factor (VEGF) for neovascular age-related macular degeneration (nAMD) with regard to real-life requirements.
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