Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Graefe's Archive for Clinical and Experimental Ophthalmology
Published in: Graefe's Archive for Clinical and Experimental Ophthalmology 3/2020

Open Access 01-03-2020 | Macular Degeneration | Retinal Disorders

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

Authors: Tomas Bro, Magdalena Derebecka, Øystein Kalsnes Jørstad, Andrzej Grzybowski

Published in: Graefe's Archive for Clinical and Experimental Ophthalmology | Issue 3/2020

Login to get access

Abstract

Purpose

To analyse current off-label use of bevacizumab for wet age-related macular degeneration (AMD) in Europe.

Methods

The study was conducted as a combined survey and literature review. It included the 22 most populous countries in Europe. In each country, ophthalmologists with particular knowledge about off-label treatment responded to a questionnaire.

Results

Answers were obtained from twenty European countries. The off-label use of bevacizumab for wet AMD greatly differed between nations; the bevacizumab proportion varied from non-existent (0%) to very high (97%). There were also large disparities within single countries (e.g. 0–80%), which were attributable to differences in regional decision-making. Both governmental institutions and national ophthalmological societies expressed highly diverging opinions on the use of off-label treatment. Intravitreal administration of bevacizumab had been a matter of legal dispute in several countries. The question about responsibility for off-label therapy mainly remained unanswered.

Conclusions

There was a highly varying utilization of bevacizumab between European countries. Despite an intention of a consistent approach to medical regulations, Europe has not yet reached a professional or political consensus on the ophthalmic off-label use of bevacizumab.
Literature
1.
2.
3.
4.
5.
6.
7.
8.
9.
Krebs I, Schmetterer L, Boltz A, Told R, Vecsei-Marlovits V, Egger S, Schonherr U, Haas A, Ansari-Shahrezaei S, Binder S, Group MR (2013) A randomised double-masked trial comparing the visual outcome after treatment with ranibizumab or bevacizumab in patients with neovascular age-related macular degeneration. Br J Ophthalmol 97:266–271. https://​doi.​org/​10.​1136/​bjophthalmol-2012-302391 CrossRefPubMed
10.
11.
12.
13.
Tuuminen R, Sipila R, Komulainen J, Saarela V, Kaarniranta K, Tuulonen A (2019) The first ophthalmic Choosing Wisely recommendations in Finland for glaucoma and wet age-related macular degeneration. Acta Ophthalmol. https://​doi.​org/​10.​1111/​aos.​14031
14.
15.
16.
17.
18.
19.
20.
Martin W, Burkhard Dick H, Scharrer A, Schayan K, Reinhard T (2018) Umfrage von BDOC, BVA, DGII und DOG zur ambulanten und stationären Intraokularchirurgie: Ergebnisse für das Jahr 2017. OPHTHALMO-CHIRURGIE 30:255–266
21.
den Exter A, Foldes ME (2014) Casebook on European Union Health Law. Maklu Publishers
22.
Court of Justice of the European Union (2013) Judgment of the Court C-535/11
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
Stanca HT, Stanca S, Tabacaru B, Boruga M, Balta F (2019) Bevacizumab in Wet AMD treatment: A tribute to the thirteen years of experience from the beginning of the anti-VEGF era in Romania. Exp Ther Med 18:4993–5000PubMedPubMedCentral
34.
35.
36.
Seregard S (2011) Avastin eller Lucentis? En fortsättning. Ett Ögonblick 3
37.
38.
Läkemedelsverket (2016) Läkemedelsverkets syn på användning av läkemedel utanför det regulatoriska godkännandet. Information från Läkemedelsverket 27:13–14
39.
40.
41.
42.
43.
44.
45.
46.
47.
THE COUNCIL OF THE EUROPEAN UNION (2006) Council Conclusions on Common values and principles in European Union Health Systems (2006/C 146/01)Official Journal of the European Union
48.
49.
50.
51.
NIVA RIVM EPHA, Weda M, Hoebert J, Vervloet M, Puigmarti CM, Damen N, Marchange S, Langedijk J, Lisman J, Dijk Lv (2017) Study on off-label use of medicinal products in the European Union European Union
Metadata
Title
Off-label use of bevacizumab for wet age-related macular degeneration in Europe
Authors
Tomas Bro
Magdalena Derebecka
Øystein Kalsnes Jørstad
Andrzej Grzybowski
Publication date
01-03-2020
Publisher
Springer Berlin Heidelberg
Published in
Graefe's Archive for Clinical and Experimental Ophthalmology / Issue 3/2020
Print ISSN: 0721-832X
Electronic ISSN: 1435-702X
DOI
https://doi.org/10.1007/s00417-019-04569-8

Other articles of this Issue 3/2020

Graefe's Archive for Clinical and Experimental Ophthalmology 3/2020 Go to the issue

Retinal Disorders

Microvascular retinal changes in pre-clinical diabetic retinopathy as detected by optical coherence tomographic angiography

Retinal Disorders

Foveal vasculature changes and nonperfusion in patients with diabetes types I and II with no evidence of diabetic retinopathy

Glaucoma

Association between optic nerve head morphology in open-angle glaucoma and corneal biomechanical parameters measured with Corvis ST

Oculoplastics and Orbit

Analysis of blink activity and anomalous eyelid movements in patients with hemifacial spasm

Pediatrics

Multifocal electroretinography in amblyopia

Retinal Disorders

Bevacizumab versus triamcinolone for persistent diabetic macular edema: a randomized clinical trial