Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2021 Mar;259(3):601-611.
doi: 10.1007/s00417-020-04803-8. Epub 2020 Aug 13.

Importance of continuous treatment with intravitreal aflibercept injections in patients with neovascular age-related macular degeneration-12-month post hoc analysis of the PERSEUS real-world evidence study

Joachim Wachtlin  1   2 , Nicole Eter  3 , Zoran Hasanbasic  4 , Georgios Keramas  4 , Christine Rech  5 , Helmut Sachs  6 , Harald Schilling  7 , Peter Wiedemann  8 , Carsten Framme  9
Affiliations
Multicenter Study

Importance of continuous treatment with intravitreal aflibercept injections in patients with neovascular age-related macular degeneration-12-month post hoc analysis of the PERSEUS real-world evidence study

Joachim Wachtlin et al. Graefes Arch Clin Exp Ophthalmol. 2021 Mar.

Abstract

Purpose: To investigate the influence of treatment regularity with intravitreal aflibercept injections (IVT-AFL injections) on visual acuity (VA) outcomes in patients with neovascular age-related macular degeneration (nAMD) enrolled in the PERSEUS trial who received at least 7 IVT-AFL injections during the first year.

Methods: This was a post hoc analysis of the PERSEUS trial, a prospective, non-interventional, multicenter cohort study, and included 370 patients with nAMD who had received ≥ 7 IVT-AFL injections during year 1. In addition to the prespecified subgroups of treatment-naïve and previously treated patients, results were compared between patients with regular (n = 209) and irregular (n = 161) treatment. Regular treatment was defined as initial dosing with monthly IVT-AFL injections for 3 months, then bimonthly IVT-AFL injections until month 12. Irregular treatment was defined as any deviation from regular treatment (provided ≥ 7 injections were received). The outcome of primary interest was the mean change in VA from baseline after 12 months. Further outcomes of interest included VA gain or loss, proportion of patients achieving reading vision, and percentage of patients with fluid.

Results: At month 12, the mean (± standard deviation, SD) VA improvement from baseline was 6.1 ± 15.6 Early Treatment Diabetic Retinopathy Study letters in the regular cohort and 2.5 ± 16.7 letters in the irregular cohort with ≥ 7 IVT-AFL injections (P = 0.0514). Best results were obtained in the treatment-naïve regular sub-cohort with a mean ± SD VA improvement of 8.0 ± 17.7 letters, whereas treatment-naïve patients with irregular treatment experienced a considerably lower VA gain (2.8 ± 20.0 letters). Irregular treatment consistently correlated with inferior results in treatment-naïve patients. At month 12, the proportion of treatment-naïve patients who had experienced a worsening of ≥ 5 letters was 29.6% in the irregular sub-cohort versus 13.6% in the regular sub-cohort (P = 0.0049). However, among the treatment-naïve patients, the mean number of injections was significantly higher in the irregular than in the regular sub-cohort (8.0 ± 1.2 vs. 7.4 ± 0.6; P = 0.0001). Furthermore, compared with the treatment-naïve, regular sub-cohort, patients in the irregular sub-cohort had more visits (19.1 ± 8.6 vs. 16.1 ± 5.7), VA tests (14.2 ± 6.9 vs. 12.0 ± 4.6), and optical coherence tomography examinations (5.1 ± 3.7 vs. 3.4.0 ± 3.0).

Conclusions: Although irregularly treated patients received more injections and more monitoring visits during the first year of IVT-AFL treatment, they experienced worse VA outcomes than regularly treated patients.

Keywords: Intravitreal aflibercept; Intravitreal injection; Neovascular age-related macular degeneration; Visual acuity.

PubMed Disclaimer

Conflict of interest statement

Nicole Eter has received lecturer fees from Novartis, Bayer, Allergan, and Roche; has received a research grant from Novartis and Bayer; and serves on advisory boards for Novartis, Bayer, Allergan, and Roche. Carsten Framme has received research support from Novartis; has received lecturer fees from Bayer, Novartis, Zeiss, Allergan, and Heidelberg Engineering; and is a consultant for Bayer. Zoran Hasanbasic is an employee at Bayer Vital GmbH. Georgios Keramas is an employee at Bayer Vital GmbH. Christine Rech is an employee at Bayer Vital GmbH. Helmut Sachs has received a speaker honorarium from Bayer and serves on advisory boards for Bayer. Harald Schilling has received travel reimbursements from Bayer, Allergan, and Dorc and has received lecturer fees from Bayer. Joachim Wachtlin has received consultation and speaking honoraria from Novartis, Bayer, Alcon, and Allergan and serves on advisory boards for Bayer, Novartis, and Allergan. Peter Wiedemann participated in clinical studies conducted by Alimera Sciences, Bayer, Regeneron, ThromboGenics, Novartis, Chengdu, Hoya Vision,and Allergan.

Figures

Fig. 1
Fig. 1
Mean change in VA within the first year in sub-cohorts of treatment-naïve (a) and previously treated (b) regular and irregular (≥ 7 IVT-AFL injections) patients (LOCF). IVT-AFL injections, intravitreal aflibercept injections; LOCF, last observation carried forward; VA, visual acuity. Adobe Illustrator CC 2020 was used to create the artwork.
Fig. 2
Fig. 2
Percentage of treatment-naïve patients with VA gain or loss with regular or irregular (≥ 7 IVT-AFL injections) treatment (LOCF) (a). Forest plots illustrating the effect of regular and irregular treatment on improvement or worsening of VA in treatment-naïve patients (LOCF) (b). IVT-AFL, intravitreal aflibercept; LOCF, last observation carried forward; CI, confidence interval; OR, odds ratio. Adobe Illustrator CC 2020 was used to create the artwork.
Fig. 3
Fig. 3
Proportion of treatment-naïve patients with reading vision (VA ≥ 70 letters) at baseline and at 12 months for regular and irregular (≥ 7 IVT-AFL injections) treatment (LOCF). IVT-AFL, intravitreal aflibercept; LOCF, last observation carried forward; VA, visual acuity. Adobe Illustrator CC 2020 was used to create the artwork.
Fig. 4
Fig. 4
Percentage of treatment-naïve patients without fluid at baseline, 4 months, and 12 months for regular and irregular (≥ 7 IVT-AFL injections) treatment (LOCF). IVT-AFL, intravitreal aflibercept injections; LOCF, last observation carried forward. Adobe Illustrator CC 2020 was used to create the artwork.
See this image and copyright information in PMC

References

    1. Jager RD, Mieler WF, Miller JW. Age-related macular degeneration. N Engl J Med. 2008;358(24):2606–2617. doi: 10.1056/NEJMra0801537. - DOI - PubMed
    1. Bloch SB, Larsen M, Munch IC. Incidence of legal blindness from age-related macular degeneration in Denmark: year 2000 to 2010. Am J Ophthalmol. 2012;153(2):209–213. doi: 10.1016/j.ajo.2011.10.016. - DOI - PubMed
    1. Campa C, Costagliola C, Incorvaia C et al (2010) Inflammatory mediators and angiogenic factors in choroidal neovascularization: pathogenetic interactions and therapeutic implications. Mediat Inflamm 2010. 10.1155/2010/546826 - PMC - PubMed
    1. Rosenfeld PJ, Brown DM, Heier JS, et al. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355(14):1419–1431. doi: 10.1056/NEJMoa054481. - DOI - PubMed
    1. Finger RP, Wiedemann P, Blumhagen F, et al. Treatment patterns, visual acuity and quality-of-life outcomes of the WAVE study - a noninterventional study of ranibizumab treatment for neovascular age-related macular degeneration in Germany. Acta Ophthalmol. 2013;91(6):540–546. doi: 10.1111/j.1755-3768.2012.02493.x. - DOI - PubMed

Publication types

MeSH terms

Grants and funding