Aflibercept as First-Line Therapy in Patients with Treatment-Naïve Neovascular Age-Related Macular Degeneration: Prospective Case Series Analysis in Real-Life Clinical Practice

Udaondo, Patricia; Salom, David; García-Delpech, S.; Cisneros-Lanuza, Á.

doi:10.1159/000445724

Cited by 12 publications

(8 citation statements)

References 39 publications

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“…e functional and structural benefits achieved confirm those of the two large pivotal clinical trials [13], as well as those others observational studies in clinical practice [14][15][16][17][18][19][20]. However, visual outcomes were lower than those reported previously [13], which may be explained by sociodemographic and disease-related differences in the populations included [18].…”

Section: Discussionsupporting

confidence: 74%

“…In this sense, pivotal studies showed that intravitreal aflibercept administered in a fixed bimonthly regimen provided satisfactory improvement in visual acuity (VA) after 52 weeks of treatment [13]. Evidence in the clinical setting indicating that the functional results obtained are more modest than those observed in the pivotal clinical trials [8,10,[14][15][16][17][18][19][20]. Patients included in these studies vary greatly with respect to sociodemographic and disease characteristics because of the differences in the time of diagnosis or in local prescription recommendations.…”

Section: Introductionmentioning

confidence: 99%

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Fixed Regimen Treatment in Unselected Naïve Patients Cohort with Neovascular Age-Related Macular Degeneration

Casaroli‐Marano

Bernal-Morales

Chamorro-López

et al. 2020

Journal of Ophthalmology

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The current treatment of neovascular age-related macular degeneration (nAMD) generates an excessive care pressure in the public health system. The search for a satisfactory treatment regimen, whose anatomical and functional stability may be achieved, is a challenge and a goal to be reached. We analyzed the outcomes in a patient cohort under fixed regimen treatment with intravitreal aflibercept (IVA). A retrospective study, with at least 1-year follow-up, in consecutive treated unselected naïve patients was carried out. Standard protocol was performed and evaluated at baseline, month 4 (after loading dose, LD), and month 12 (after fixed bimonthly regimen). One hundred six patients (123 eyes) aged 80.3 ± 7.7 years were included, receiving 6.8 ± 0.7 IVA. Visual acuity gain after LD was 5.5 ± 12.0 letters ( p < 0.0001 ). At month 12, 23 eyes (18.7%) gained ≥15 letters and 58 (47.1%) had best-corrected visual acuity ≥20/40 (70 letters). The improvement in visual acuity was lower in patients with polypoidal choroidal vasculopathy (+4.9 ± 18.1 letters; p = 0.2544) and somewhat higher in patients with retinal angiomatous proliferation (+5.4 ± 12.3 letters; p = 0.0373 ). Dry macula was present in only 9.8% of cohort at baseline vs. 69.7% at month 12 ( p < 0.0001 ). Atrophy was the most observed complication and related to the elderly patients. The average of follow-up visits was 3 ± 0.5. Functional and anatomical improvement were observed with IVA in a fixed bimonthly regimen treatment after LD, with results maintained up to one year with a good compliance. The fixed bimonthly regimen optimized patient management and logistic issues.

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Section: Discussionsupporting

confidence: 74%

Section: Introductionmentioning

confidence: 99%

Fixed Regimen Treatment in Unselected Naïve Patients Cohort with Neovascular Age-Related Macular Degeneration

Casaroli‐Marano

Bernal-Morales

Chamorro-López

et al. 2020

Journal of Ophthalmology

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“…Four other studies looked at bimonthly dosing in a total of 140 patients and evaluated the efficacy of bimonthly dosing for a period of~1 year. [25][26][27][28] The studies showed that patients on average gained+9 EDTRS letters in all studies combined which was equivalent to the results of the larger RCT. Futhermore, the studies looked at a range of different CNV pathologies including PCV, PED and RAP and showed the efficacy of the drug in all subtypes.…”

Section: Beyond the First Yearsupporting

confidence: 58%

Aflibercept in age-related macular degeneration: evaluating its role as a primary therapeutic option

Ashraf

Souka

2017

Eye

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The recent VIEW studies have demonstrated the non-inferiority of monthly and bi-monthly aflibercept in the management of wet age related macular degeneration (AMD) compared with ranibizumab. However, the current data are limited mainly to fixed dosing regimens with few studies looking at flexible dosing regimens of aflibercept in wet AMD. In addition, recent data from the VIEW 96 week extension has shown that patients being shifted from fixed dosing regimens to PRN have shown a drop in visual acuity and increase in central macular thickness. This is an indication that fixed dosing, a non-sustainable option, is only effective as long as it is continued. Regimens such as treat and extend (TAE) and pro-re nata (PRN) have been studied extensively in ranibizumab and bevacizumab and have shown to be effective options. With the presence of effective, established and less costly drugs such as ranibizumab and bevacizumab, the role of aflibercept as a primary treatment modality has yet to be clearly defined. The current review provides an analysis of the VIEW studies, as well as the extension phases. It also looks at post hoc analysis of predictors of response and outcomes. We have also conducted a search on studies comparing between PRN regimens using aflibercept and other anti-VEGF agents. This review also explores cheaper off label aflibercept; ziv-aflibercept in the treatment of wet AMD. The main purpose of the review is to delineate the role of aflibercept as a primary therapeutic option and if there are any significant advantages that would advocate its use over alternative anti-VEGF drugs. Finally, we propose a treatment algorithm for patients being started on aflibercept during the first year and thereafter.

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“…Sample size estimation was based on previous nAMD studies on treatment use under real conditions in Spain. 11–18…”

Section: Methodsmentioning

confidence: 99%

Burden of disease assessment in patients with neovascular age-related macular degeneration in Spain: Results of the AMD-MANAGE study

Marín¹,

Paniagua

Gómez-Baldó

et al. 2021

European Journal of Ophthalmology

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Background/Aims: The present study evaluates the burden of neovascular age-related macular degeneration (nAMD) to Healthcare System and patients, describing the management and treatment effectiveness in routine clinical practice in Spain. Methods: Observational, non-interventional, cross-sectional, retrospective (24 months), multicentre study including patients who started treatment with licensed vascular endothelial growth factor inhibitors (anti-VEGF) for nAMD with a minimum follow up of 24 months. Results: 126 evaluable patients were included with mean (SD) age of 79.1 (7.5) years. From diagnosis, it took a mean (SD) of 0.5 (0.5) months for the first treatment. Throughout 24 months, mean (SD) number of visits per patient was 16.0 (5.0), 9.4 (4.3) associated intravitreal injection. There were 1186 injection visits, 53.6% of them only with injection and 46.3% with injection and tests. After loading phase, preferred treatment regimens were T&E (46.0%), PRN (44.4%), fixed regimen (4.0%), and others (5.6%). Total number of visits in patients with T&E and PRN were 16.5 (5.7) and 15.5 (4.7), respectively. After complete loading phase, mean (SD) time between two consecutive treatment injections was 2.2 (1.6) months. 27.8% patients underwent a treatment change, being lack of response the most frequent reason to change (43.2%). Mean (SD) best-corrected visual acuity change was 2.1 (15.9) letters at 24 months. Conclusion: This study showed an important burden to Healthcare System and patients related to monitoring visits. More efficacious and longer lasting treatments could be useful to increase treatment intervals, thus reducing the burden of patients and caregivers and the use of healthcare resources.

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Aflibercept as First-Line Therapy in Patients with Treatment-Naïve Neovascular Age-Related Macular Degeneration: Prospective Case Series Analysis in Real-Life Clinical Practice

Cited by 12 publications

References 39 publications

Fixed Regimen Treatment in Unselected Naïve Patients Cohort with Neovascular Age-Related Macular Degeneration

Fixed Regimen Treatment in Unselected Naïve Patients Cohort with Neovascular Age-Related Macular Degeneration

Aflibercept in age-related macular degeneration: evaluating its role as a primary therapeutic option

Burden of disease assessment in patients with neovascular age-related macular degeneration in Spain: Results of the AMD-MANAGE study

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