Authors' objectives: Background: Age-related macular degenerative disease (AMD) is the most common cause of permanent visual handicap in the Western population. Previous treatment modalities like laser coagulation had very limited effect and the introduction of anti-vascular growth factor (VGEF) inhibitors for intraocular use was therefore a major breakthrough. The idea emanated from the observation in case reports that a VGEF inhibitor used as an anti-tumour agent, bevacizumab, had a positive effect on visual acuity in patients with AMD. Bevacizumab was however never evaluated for intraocular use, instead a new similar substance, ranibizumab, went through the registration process. Ranibizumab was later followed by a third substance, aflibercept. The price for these substances is quite high and use of the considerably cheaper bevacizumab started. There is now an extensive off label use of intraocularly administered bevacizumab on all approved indications for ranibizumab and aflibercept. Objective: Are there any clinically relevant differences in efficacy or safety between the three antiVGEF compounds bevacizumab, ranibizumab and aflibercept, when used for intraocular treatment of age-related macular degeneration, diabetic macular edema, retinal vein occlusion or choroidal neovascularization due to pathologic myopia?

Authors' results and conclusions: The analysis did not identify any clinically relevant differences in efficacy (measured as change in visual acuity) or safety (measured as risk for mortality, cardiovascular mortality, myocardial infarction, stroke, endophthalmitis or serious ocular events) between intraocular bevacizumab, ranibizumab or aflibercept. The degree of certainty of this conclusion varies with indication and outcome, the highest certainty of evidence exist for patients with AMD and for the comparison bevacizumab versus ranibizumab (for most outcomes GRADE⊕⊕⊕). For safety related outcomes, the highest certainty of evidence (GRADE⊕⊕⊕) for a lack of clinically relevant difference, is available for the comparison bevacizumab versus ranibizumab for patients with AMD and DME regarding mortality, cardiovascular mortality, myocardial infarction, stroke, serious ocular events, and for the outcome endophthalmitis regarding patients with AMD but not those with DME. A similar certainty of evidence (GRADE⊕⊕⊕), regarding safety related outcomes is available for the comparison bevacizumab versus aflibercept for patients with AMD or DME (i.e. mortality, cardiovascular mortality, myocardial infarction, stroke, serious ocular events). For the remaining indications and outcomes, the certainty of evidence is less extensive or somewhat inconsistent, and largely lacking for the indications RVO and PM.

Project Status: Completed

Year Published: 2017

URL for published report: https://mellanarkiv-offentlig.vgregion.se/alfresco/s/archive/stream/public/v1/source/available/sofia/su4372-1728378332-332/native/2017_96%20HTA-rapport%20%c3%96gon.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Organisation Name: The Regional Health Technology Assessment Centre

Contact Address: The Regional Health Technology Assessment Centre, Region Vastra Gotaland, HTA-centrum, Roda Straket 8, Sahlgrenska Universitetssjukhuset, 413 45 GOTHENBORG, Sweden

Contact Name: hta-centrum@vgregion.se

Contact Email: hta-centrum@vgregion.se