The retinal world has been revolutionized by optical coherence tomography (OCT) and anti-vascular endothelial growth factor (VEGF) therapy. This overview of reviews and meta-analyses suggest that anti-VEGF treatments do not increase the risk of systemic adverse events, but that caution might be advisable in older patients with age-related macular degeneration who may be at higher risk of hemorrhagic events when receiving ranibizumab.
Compared with control treatments, ranibizumab may be associated with an increase in the risk of nonocular hemorrhage in patients with age-related macular degeneration. Compared with ranibizumab, bevacizumab did not appear to be associated with an increase in the risk of systemic adverse events in the most recent and exhaustive reviews. Anti-VEGF treatments did not increase the risk of systemic adverse events when compared with control regimens similarly, there was no increase in systematic adverse events when treatment was given on a monthly schedule vs an as-needed regimen. All reviews used an objective scale to assess methodological risk of bias in their included studies, the Cochrane Risk of Bias Tool being the most commonly used (16 reviews ). The median (interquartile range) PRISMA and AMSTAR scores were 23 of 27 (15-27) and 8 of 11 (5-11), respectively, but 5 reviews (25%) scored below 20 and 7, respectively. Of these, 11 analyzed systemic adverse events as the primary outcome. We retrieved 21 systematic reviews published between January 1, 2011, and June 30, 2016. The quality of the systematic reviews was assessed with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist and A Measurement Tool to Assess Systematic Reviews (AMSTAR) checklist, version 1. We describe the summary measures of association between anti-VEGF treatments and outcomes reported in each systematic review. This systematic search of PubMed and the Cochrane Central Register of Controlled Trials database includes meta-analyses and systematic reviews. This overview of systematic reviews evaluates systemic adverse events associated with intravitreal anti-VEGF treatments in patients with neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion. The systemic safety of intravitreal anti–vascular endothelial growth factor (anti-VEGF) medications is still a matter of debate.
Overall, the results indicate that an individualized treatment approach with anti-VEGF using visual acuity and OCT-guided re-treatment criteria may be appropriate for most patients with nAMD. There is a small increase in risk of systemic adverse events for PRN treated patients. PRN treatment resulted in minor but statistically significant decrease in mean BCVA which may not be clinically meaningful. The studies were considered to have a moderate risk of bias. After 2 years, the total number of intravitreal injections required by the patients in the PRN arms were 8.4 (95% CI 7.9 to 8.9) fewer than those having monthly treatment. Systemic adverse events were higher in PRN treated patients, but these differences were not statistically significant. After 2 years, the weighted mean difference in best corrected visual acuity (BCVA) was 1.9 (95% CI 0.5 to 3.3) ETDRS letters in favour of monthly treatment. We included 3 head-to-head studies (6 reports) involving more than 2000 patients. Risk of bias assessment was performed after the Cochrane Handbook for Systematic Reviews of Interventions.
The last literature search was conducted in December 2014. Four bibliographic databases were searched for randomised controlled trials comparing both treatment regimens directly (head-to-head studies). The intervention was PRN treatment and the comparator was monthly treatment with VEGF-inhibitors. Replacement of monthly by PRN treatment can only be justified if there is no difference in patient relevant outcomes. Regular monthly administration of vascular endothelial growth factor (VEGF) inhibitors is an established gold standard treatment, but this approach is costly. To investigate whether treatment as required 'pro re nata' (PRN) versus regular monthly treatment regimens lead to differences in outcomes in neovascular age-related macular degeneration (nAMD).
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