Authors' objectives: To review evidence on the efficacy and safety of treatment with Ranibizumab, Pegaptanib and Bevacizumab in AMD.

Authors' results and conclusions: Of the search, 495 paper references were achieved. The first selection was focused on: discarding duplicates; excluding those papers whose title did not match the topic to be assessed; and selecting those papers, which met the inclusion criteria, through reading their summaries. After this selection, 453 papers were excluded (86 of them were duplicates) and 42 were selected for full reading. After reading these 42 papers, 25 were selected for systematic review. Of them, only 4 were phase III clinical trials (which resulted in 5 papers), two on Ranibizumab (both with medium quality) and two on Pegaptanib (one of medium and another of low quality). The remaining 20 papers corresponded to studiesof a range of designs; and they were only used to extract additional information on the drugs’ adverse effects, except for the case of Bevacizumab, which –as there were no clinical trials- were also used to assess the effectiveness. Ranibizumab, as compared to placebo as to Verteporfin, is the drug that gets better results in terms of AMD stabilization(between 0 and 1.2% of severe visual losses as opposed to 13-14% in the control groups), and it even achieves improvement in visual acuity in some cases. Pegaptanib was only compared to placebo, also showing less frequency of visual severe losses. The case series on Bevacizumab showed improvements in visual acuity after treatment and reduction in the lesions’ size. Serious adverse effects hardly happened in all treatments. The adverse effects’ sum (of any magnitude, although most of them were mild and transitory) was more frequent in the groups treated with Ranibizumab and Pegaptanib than in the control ones (placebo and Verteporfin). The case series on Bevacizumab showed similar adverse effects with this drug than the clinical trials on Ranibizumab.

Authors' recommendations: The treatment with Ranibizumab showed the best results as regards to efficacy based on evidence of a medium quality. The evidence on efficacy and safety of Bevacizumab is limited, for no clinical trial has been published up to date. However the results from the case series show improvements after treatment and it had similar adverse effects to Ranibizumab’s. The treatment with Pegaptanib showed better results than placebo, above all in terms of severe visual losses, but of a lesser magnitude than those found with Ranibizumab (indirect comparison).

Authors' methods: Review

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/eficacia-y-seguridad-de-las-nuevas-terapias-para-la-degeneracion-macular-asociada-a-la-edad/

Year Published: 2007

URL for published report: https://www.aetsa.org/download/publicaciones/antiguas/AETSA_P_2007_10_Deg_Macular.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)