Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea

Abstract

Purpose

To investigate the efficacy and safety of intravitreal aflibercept (IVT-AFL) in Asian patients with neovascular age-related macular degeneration (nAMD) in a real-world clinical setting.

Patients and Methods

In this analysis of a prospective, regulatory, postmarketing surveillance study for IVT-AFL, 3115 patients with nAMD were included and followed for 8 months. The mean changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were analyzed using last observation carried forward method. A post hoc subgroup analysis and a multivariate logistic regression analysis were also performed to assess factors related to treatment outcomes.

Results

Mean BCVA improved from 0.62 to 0.51 logarithm of minimum angle resolution and mean CRT decreased from 383.3 to 289.7 μm, with a mean of 3.4 injections during the 8-month follow-up. In the subgroup analysis, patients who had received 3 initial monthly doses had significantly better anatomical improvements than those treated as needed. Patients with confirmed polypoidal choroidal vasculopathy (PCV) had significantly better anatomical improvements and better visual recovery than those with other types of nAMD. The multivariate regression analysis demonstrated that age, injection number, PCV, and baseline BCVA were significantly associated with higher odds of gaining 3 lines at 8 months, and sex, injection number, PCV, and baseline CRT were associated with CRT ≤250 µm at 8 months. No new safety findings were identified.

Conclusion

IVT-AFL was effective and well tolerated in a real-world setting with a large number of Asian patients with nAMD. Number of injections and PCV were important determinants for improved treatment outcomes.

Keywords:

• aflibercept
• Asian
• neovascular age-related macular degeneration
• polypoidal choroidal vasculopathy
• postmarketing surveillance
• real-world

Data Sharing Statement

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Statement of Ethics

Before conducting the study, institutional ethics approval was obtained from the Institutional Review Board of each participating study sites and the study was registered on ClinicalTrials.gov (NCT01783925). A complete list of study sites and investigators is in the Supplementary Table S7. Patients have given their written informed consent. All decisions in terms of diagnostic procedures, treatments, and management of the disease were fully dependent on mutual agreements between the patients and the investigator, following the principles of the Declaration of Helsinki.

Acknowledgments

The authors thank the investigators and their patients who participated in this PMS study. The authors thank Hyeseon Lee from Dream CIS Ltd., for medical writing and editorial support for this manuscript.

Disclosure

Min Sagong received research grants and consultation fees from Bayer, Novartis, and Allergan. Guihyun Moon is an employee of Bayer Korea, Seoul, Republic of Korea; also reports that Bayer Korea sponsored the study and was involved in the study conception, design, protocol writing, study coordination, data analysis, data interpretation, manuscript writing, editing, and submission, and reports that Dream CIS company, was a Contract research organization involved with data analysis, manuscript preparation and editing. Gahyung Ryu has nothing to declare. Donghyoun Noh has nothing to declare.