Off-label use of bevacizumab for wet age-related macular degeneration in Europe

Bro, Tomas; Derebecka, Magdalena; Jørstad, Øystein Kalsnes; Grzybowski, Andrzej

doi:10.1007/s00417-019-04569-8

Cited by 44 publications

(38 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Bevacizumab (IVB) is a monoclonal, humanized, fulllength antibody inhibiting vascular endothelial growth factor (VEGF). Currently, bevacizumab is widely used in DME treatment as an off-label drug [9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Diabetic Macular Edema Treatment with Bevacizumab Does Not Depend on the Retinal Nonperfusion Presence

Sędziak-Marcinek

Teper

Chełmecka

et al. 2021

Journal of Diabetes Research

View full text Add to dashboard Cite

This study evaluated the relationship between the retinal nonperfusion area (NPA) presence and the effectiveness of bevacizumab treatment (IVB) in patients with diabetic macular edema (DME). It also tested the prognostic usefulness of ultra-wide-field fluorescein angiography (UWFFA) and OptosAdvance software for diabetic retinopathy monitoring. Eighty-nine patients with DME with a macular central subfield thickness CST ≥ 250 μ m , with ( N = 49 eyes) and without ( N = 49 eyes) retinal NPA, underwent nine bevacizumab injections over 12 months. NPA distribution, leakage area distribution, microaneurysm (MA) count, macular CST, diabetic retinopathy severity, and best-corrected visual acuity (BCVA) were assessed. The results show that bevacizumab reduced the macular CST from 420 to 280 μm ( p < 0.001 ) and improved BCVA ( p < 0.001 ) by about 10 ETDRS letters in both groups of patients. Additionally, the therapy reduced total retinal NPA from 29 (14-36) mm2 to 12 (4-18) mm2 (Me (Q1-Q3); p < 0.001 ) in patients with diagnosed nonperfusion. The effect of the therapy measured with vascular leakage, MA count, BCVArelative, and CSTrelative strongly depended on the zone of the retina and the NPA distribution. We conclude that the bevacizumab treatment had a positive effect on DME and BCVA in both study groups and on the size of retinal NPA in patients with retinal nonperfusion.

show abstract

Section: Introductionmentioning

confidence: 99%

Diabetic Macular Edema Treatment with Bevacizumab Does Not Depend on the Retinal Nonperfusion Presence

Sędziak-Marcinek

Teper

Chełmecka

et al. 2021

Journal of Diabetes Research

View full text Add to dashboard Cite

show abstract

“…While no significant drop of visual acuity was reported after the switch, 18-19% of patients were found to be non-responder to bevacizumab and switched back to ranibizumab or aflibercept [41]. Different attitudes towards the off-label use of bevacizumab in nAMD across the European Nations have been shown by a recent report [42]; indeed in Europe the use of bevacizumab in nAMD may vary considerably, ranging from non-existent (Switzerland, Hungary, Denmark) to very frequent (Romania, Bulgaria, Finland, Ireland, Netherlands). Moreover, large disparities within single countries, resulting from different organization of the National Health Systems and regional autonomies have been reported [42].…”

Section: Current Trends and Future Directionsmentioning

confidence: 98%

“…Different attitudes towards the off-label use of bevacizumab in nAMD across the European Nations have been shown by a recent report [42]; indeed in Europe the use of bevacizumab in nAMD may vary considerably, ranging from non-existent (Switzerland, Hungary, Denmark) to very frequent (Romania, Bulgaria, Finland, Ireland, Netherlands). Moreover, large disparities within single countries, resulting from different organization of the National Health Systems and regional autonomies have been reported [42]. In the United Kingdom, until recent years, the General Medical Council and the National Institute for Health and Care Excellence (NICE) guidelines have not encouraged ophthalmologists to use bevacizumab in nAMD [43].…”

Section: Current Trends and Future Directionsmentioning

confidence: 99%

Intravitreal Bevacizumab in Neovascular Age-Related Macular Degeneration as First Choice: a New Italian Ruling

Erba¹,

Scialdone²,

Casalino³

2020

Med Hypothesis Discov Innov Ophthalmol

View full text Add to dashboard Cite

Background: Intravitreal vascular endothelial growth factor (VEGF) inhibitors represent the mainstay of neovascular age-related macular degeneration (nAMD) treatment. Although bevacizumab has been the first anti-VEGF used in ophthalmology, it is unlicensed for intraocular use. However, the favourable cost-benefit balance has favoured its widespread use. We aimed to present relevant literature regarding the safety profile and the regulatory issues of intravitreal bevacizumab use. Methods: In this narrative review we report relevant studies regarding the safety profile of intravitreal bevacizumab. Expert commentary is provided and an overview of the current scenario and possible future directions discussed. Results: Randomized controlled trials have demonstrated that bevacizumab is not inferior to the licensed anti-VEGF agents showing similar efficacy and safety profiles. However, a significant debate on the regulatory issues of intravitreal bevacizumab used as ‘off label’ first-line treatment in nAMD still persists. Recently, the Regional Health System of Lombardia in Italy decided to only cover the expenses of bevacizumab, forcing clinicians to use bevacizumab as the first choice in the treatment of nAMD. Issues about the practical implications of this decision are discussed. Conclusion: The use of intravitreal bevacizumab as first-line therapy in nAMD remains controversial. Many differences in the regulatory aspects still persist among the European countries and sometimes within the same countries, like Italy. Of note the clinical scenario will be modified in future by the introduction of newly developed anti-VEGF agents and anti-VEGF biosimilars.

show abstract

“…Although multiple studies have confirmed the comparable efficacy and safety of intravitreal bevacizumab (Avastin ® ) administration to registered anti-VEGF drugs (4)(5)(6)(7)(8)(9), bevacizumab continues to have an off-label status. A recent study evaluating bevacizumab use in 20 European countries showed that a consensus on the ophthalmic off-label use of bevacizumab in Europe has not yet been reached and member states have different approaches (10). Bevacizumab intravitreal injections quota significantly varies in different European countries and even developed economies use bevacizumab after informed consent is obtained.…”

Section: Influence Of Unilateral Intravitreal Bevacizumab Injection Omentioning

confidence: 99%

Influence of unilateral intravitreal bevacizumab injection on the incidence of symptomatic choroidal neovascularization in the fellow eye in patients with neovascular age‑related macular degeneration (Review)

et al. 2020

View full text Add to dashboard Cite

Neovascular age-related macular degeneration (neovascular ARMD) represents only 10% of ARMD cases but is responsible, if untreated, for quick and severe central vision loss due to major macular changes. The presence of choroidal neovascularization (CNV) in one eye is associated with an approximately 10% risk of CNV development in the fellow eye each year. Intravitreal anti-VEGF therapy has quickly evolved as the standard treatment in neovascular ARMD in the last decade due to significant anatomical and functional improvements, especially in the early stages. In many reports an improvement in the untreated fellow eye was mentioned and systemic exposure was soon confirmed for all anti-VEGF agents after unilateral intravitreal injection. In particular, bevacizumab intravitreal injection is followed by a consistent reduction of serum VEGF levels and the drug was shown to have the longest serum half-life raising important debates about its safety. Once bevacizumab was detected in the fellow eye of an animal model after unilateral injection, the possible influence on fellow eye conversion rate into neovascular ARMD was questioned. Although comparative studies have not found statistically significant differences between drugs regarding the incidence of symptomatic CNV in the fellow eye during treatment, we observed, on a retrospective 36-month evaluation, a reduced incidence of symptomatic CNV in the fellow eye that might be explained by the consistent systemic exposure of bevacizumab. Contents 1. Introduction 2. The current state of knowledge regarding the systemic exposure and the influence of unilateral intravitreal anti-VEGF injection on the fellow eye 3. Conclusions

show abstract

Off-label use of bevacizumab for wet age-related macular degeneration in Europe

Cited by 44 publications

References 24 publications

Diabetic Macular Edema Treatment with Bevacizumab Does Not Depend on the Retinal Nonperfusion Presence

Diabetic Macular Edema Treatment with Bevacizumab Does Not Depend on the Retinal Nonperfusion Presence

Intravitreal Bevacizumab in Neovascular Age-Related Macular Degeneration as First Choice: a New Italian Ruling

Influence of unilateral intravitreal bevacizumab injection on the incidence of symptomatic choroidal neovascularization in the fellow eye in patients with neovascular age‑related macular degeneration (Review)

Contact Info

Product

Resources

About