Clinical Ophthalmology (Aug 2021)
Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea
Abstract
Gahyung Ryu,1,2 Donghyoun Noh,1,2 Guihyun Moon,3 Min Sagong1,2 1Department of Ophthalmology, Yeungnam University College of Medicine, Daegu, Republic of Korea; 2Yeungnam Eye Center, Yeungnam University Hospital, Daegu, Republic of Korea; 3Bayer Korea Ltd, Seoul, Republic of KoreaCorrespondence: Min SagongDepartment of Ophthalmology, Yeungnam University College of Medicine, 170 Hyunchungro, Nam-gu, Daegu, 42415, Republic of KoreaTel +82-53-620-3443Fax +82-53-626-5936Email [email protected]: 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
