Effectiveness of anti-vascular endothelial growth factors in neovascular age-related macular degeneration and variables associated with visual acuity outcomes: Results from the EAGLE study.

Giovanni Staurenghi,Stela Vujosevic,Francesco Bandello,Giulia Barbati,Maria Vadalà,Claudio Furino,Chiara Biancotto,Monica Varano,Michele Reibaldi,Elena Peruzzi,Federico Ricci,Vito Fenicia,Francesco Viola,Stefania Bassanini,Vikas Khetan

doi:10.1371/journal.pone.0256461

Abstract

To assess the overall effectiveness of anti-vascular endothelial growth factor (VEGF) therapy in treatment-naïve patients with neovascular age-related macular degeneration (nAMD) in a clinical practice setting. EAGLE was a retrospective, 2-year, cohort observational, multicenter study conducted in Italy that analyzed secondary data of treatment-naïve patients with nAMD. The primary endpoint evaluated the mean annualized number of anti-VEGF injections at Years 1 and 2. The main secondary endpoints analyzed the mean change in visual acuity (VA) from baseline and variables associated with visual outcomes at Years 1 and 2. Of the 752 patients enrolled, 745 (99.07%) received the first dose of anti-VEGF in 2016. Overall, 429 (57.05%) and 335 (44.5%) patients completed the 1- and 2-year follow-ups, respectively. At baseline, mean (standard deviation, SD) age was 75.6 (8.8) years and the mean (SD) VA was 53.43 (22.8) letters. The mean (SD) number of injections performed over the 2 years was 8.2 (4.1) resulting in a mean (SD) change in VA of 2.45 (19.36) (P = 0.0005) letters at Year 1 and -1.34 (20.85) (P = 0.3984) letters at Year 2. Linear regression models showed that age, baseline VA, number of injections, and early fluid resolution were the variables independently associated with visual outcomes at Years 1 and 2. The EAGLE study analyzed the routine clinical practice management of patients with nAMD in Italy. The study suggested that visual outcomes in clinical practice may be improved with earlier diagnosis, higher number of injections, and accurate fluid resolution targeting during treatment induction.

Highlights

Age-related macular degeneration (AMD) is a progressive degenerative disease affecting the retina and is a leading cause of severe irreversible vision loss in the elderly, if left untreated
Linear regression models showed that age, baseline visual acuity (VA), number of injections, and early fluid resolution were the variables independently associated with visual outcomes at Years 1 and 2
The study suggested that visual outcomes in clinical practice may be improved with earlier diagnosis, higher number of injections, and accurate fluid resolution targeting during treatment induction

Summary

Study design

EAGLE was a retrospective, 2-year, cohort observational, multicenter study conducted at 27 clinical sites across Italy. The association of variables such as age, gender, baseline VA, time from diagnosis to treatment, number of injections in the first year of treatment, LP, bilateral diagnosis and baseline type of MNV lesion on VA outcomes of the treated eye were assessed by means of linear regression models at Years 1 and 2 in the whole population and in the subgroup of patients who completed the LP. To evaluate factors associated with VA outcomes, linear regression models were estimated at Years 1 and 2 in the 1stCA_EA and 2ndCA_EA populations, using the following covariates: age, gender, baseline VA, time from diagnosis to treatment, baseline type of MNV lesion, number of injections during the first year, bilateral diagnosis, and loading phase completion. CI, confidence interval; EA, effectiveness analysis; n, number of patients who had at least two injections; SD, standard deviation

Results

Conclusions

Introduction

Discussion