Abstract
The use of anti-vascular endothelial growth factor (VEGF) agents has profoundly changed the prognosis of neovascular age-related macular degeneration (nAMD). As clinical experiences have accumulated, it has become mandatory to summarize data to give information that can be useful in everyday practice. We conducted a systematic review to identify randomized controlled trials (RCTs) and observational studies that reported 12-month changes in best-corrected visual acuity (BCVA) in patients with nAMD on anti-VEGF monotherapy. Data were analyzed in a random-effects meta-analysis with BCVA change as the primary outcome. Meta-regression was conducted to evaluate the impact of multiple covariates. Four hundred and twelve heterogeneous study populations (109,666 eyes) were included. Anti-VEGFs induced an overall improvement of +5.37 ETDRS letters at 12 months. Meta-regression showed that mean BCVA change was statistically greater for RCTs (p = 0.0032) in comparison with observational studies. Populations following a proactive regimen had better outcomes than those following a reactive treatment regimen. Mean BCVA change was greater in younger populations, with lower baseline BCVA and treated with a higher number of injections (p < 0.001). Our results confirm that anti-VEGFs may produce a significant functional improvement at 12 months in patients with nAMD.
Highlights
Neovascular age-related macular degeneration is the leading cause of irreversible vision loss among the over-50s living in developed countries, with a prevalence rate between 5.8% and 15.1% of the population, which constantly increases with age [1]
Studies based on a pro re nata (PRN) or a treat and extend (TAE) dosing strategy led to results that in some cases emulated those obtained with monthly dosing [2]
This meta-analysis consists of 109,666 eyes and it is the largest and most comprehensive research to date that aim at synthetizing the clinical efficacy of intravitreal ranibizumab, aflibercept, bevacizumab, and brolucizumab in the treatment of Neovascular age-related macular degeneration (nAMD) at 12 months
Summary
Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has become the treatment of choice for nAMD, supported by evidence from randomized clinical trials (RCTs) as well as routine clinical practice, demonstrating efficacy in preventing visual loss and improving vision [1,2]. Three anti-VEGF drugs (ranibizumab, aflibercept, and brolucizumab) are authorized for the treatment of nAMD, whilst bevacizumab, developed and approved for different types of tumors, is widely employed in an off-label fashion in many countries. Patients in real-world clinical settings may be treated with dosing and/or regimens that differ from what recommended in the product’s label, mainly due to logistic problems and economic considerations [3–6]. The objective of this study was to synthesize the evidence available about the efficacy of intravitreal anti-VEGFs for the treatment of nAMD based on a systematic review and a meta-analysis of published RCTs and observational/real-life studies. The aim of this work is to give an answer to the following ten questions: Are results between RCTs and real-life/observational studies different?
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