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. 2024 Nov;13(11):2839-2853.
doi: 10.1007/s40123-024-01021-x. Epub 2024 Sep 5.

Predictors of Disease Activity After Anti-VEGF Treatment for Neovascular Age-Related Macular Degeneration Using Real-World Data from the PROOF Study

Min Sagong  1 , Jae Hui Kim  2 , Se Joon Woo  3 , Yu Cheol Kim  4 , Heeyoon Cho  5 , Young Hoon Lee  6 , Iksoo Byon  7 , Young Joon Jo  8 , Hee Seung Chin  9 , Jeonghee Kim  10 , Jae Eun Chae  11 , Se Woong Kang  12
Affiliations

Predictors of Disease Activity After Anti-VEGF Treatment for Neovascular Age-Related Macular Degeneration Using Real-World Data from the PROOF Study

Min Sagong et al. Ophthalmol Ther. 2024 Nov.

Abstract

Introduction: The aim of this study was to investigate the predictive factors for persistent disease activity following anti-vascular endothelial growth factors (anti-VEGF) and their long-term effects in patients to be treated for neovascular age-related macular degeneration (nAMD) under real-world conditions.

Methods: Retrospective data analysis of the PROOF study, a multi-center real-world retrospective chart review conducted across Korea in patients with nAMD included treatment-naive patients with nAMD who received first anti-VEGF (ranibizumab, bevacizumab, or aflibercept) between January 2017 and March 2019 was performed. All 600 patients (cohort 1) had a minimum follow-up of 12 months of which 453 patients (cohort 2) were followed-up for 24 months from baseline.

Results: At month 12 after anti-VEGF therapy, 58.10% (95% confidence interval [CI]: 54.09, 62.12) of patients and at month 24, 66.02% of patients continued to have persistent retinal fluid. At both months 12 and 24, predictive factors for persistent disease activity were fibrovascular pigment epithelial detachments (PED) (P = 0.0494) and retinal fluid at month 3 after loading phase (P = 0.0082). The mean changes in visual acuity were + 6.2, + 10.1, and + 13.3 letters and in the central subfield thickness were - 79.1 µm, - 96.3 µm, and - 134.4 µm at 12 months from baseline, in the bevacizumab, aflibercept, and ranibizumab groups, respectively.

Conclusions: The presence of retinal fluid after loading phase and fibrovascular PED were predictors of persistent disease activity after at least 1 year of anti-VEGF treatment.

Keywords: Aflibercept; Age-related macular degeneration; Anti-vascular endothelial growth factor; Best-corrected visual acuity; Bevacizumab; Ranibizumab; Real world.

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Conflict of interest statement

Min Sagong reports honoraria from Allergan, Bayer, Novartis, and Roche for lecture fees, consultancy, and board membership and reports research grants from Allergan, Bayer, and Novartis. Jae Hui Kim reports grants from Novartis and Bayer. Se Joon Woo is a consultant of Samsung Bioepis, Alteogen, Curacle, Novelty Nobility, Sometech, and Pharmabcine; reports grants from Samsung Bioepis, Curacle, Alteogen, Bayer, Novartis, Geneuintech and Roche; reports lecture fees from Novartis, Bayer, Allergan/AbbVie, Roche and Samil; and owns equity of RetiMark and Panolos Bioscience. Yu Cheol Kim is a consultant for Novartis and Bayer; received honoraria from Allergan, Bayer, and Novartis; and research grants from Chong Kun Dang Pharm., SCD Pharm., Bayer, and Novartis. Heeyoon Cho reports lecture fees and consultancy from Allergan, Bayer, and Novartis. Young Hoon Lee and Hee Seung Chin have no financial disclosures. Iksoo Byon is a consultant/advisor for Novartis, Bayer, and AIinsight Inc and reports grants from Novartis and Busan Technopark. Young Joon Jo reports grants from Bayer and Novartis. Jeonghee Kim is an employee of Novartis Korea Ltd. Jae Eun Chae is an employee of LSK Global Pharma Services, Korea. Se Woong Kang has served on advisory boards for Novartis, Bayer, Allergan, Alcon, and Samchundang and has received consultancy fees and payments for lectures from these companies.

Figures

Fig. 1
Fig. 1
Patient disposition
Fig. 2
Fig. 2
Presence of retinal fluid from baseline to 24 months. Cohort 1, N = 600. IRF intra-retinal fluid, RPE retinal pigment epithelium, SRF sub-retinal fluid, VEGF vascular endothelial growth factor
Fig. 3
Fig. 3
Predictive factors of treatment outcomes (persistent disease activity) at year 1 and 2. AFL aflibercept, BL baseline, BVZ bevacizumab, CI confidence interval, DA disease activity, Inj injection, M month, PCV polypoidal macular vasculopathy, PED pigment epithelial detachment, VA visual acuity. Testing for finding predictive factors of treatment outcomes (persistent disease activity) using GEE analysis using robust standard errors or parameter estimates
Fig. 4
Fig. 4
A VA gain in patients staying on index therapy. B CST reduction in patients staying on index therapy. C VA before and after index therapy switch. D CST before and after index therapy switch. *Testing for difference among staying-on index therapy groups at each timepoint (Kruskal–Wallis test); **Testing for difference between ranibizumab and each staying-on index therapy groups at each timepoint (Wilcoxon signed-rank test). A aflibercept, B bevacizumab, BL baseline, CST central subfield thickness, EDTRS Early Treatment Diabetic Retinopathy Study, R ranibizumab, VA visual acuity
Fig. 5
Fig. 5
Change in (A) VA and (B) CST from baseline stratified by frequency of injection over 24 months. Frequent injection group: patients who were treated with at least seven injections in the first year. * Testing for difference between frequent and infrequent injections at each timepoint (Wilcoxon signed-rank test). BL baseline, CST central subfield thickness, EDTRS Early Treatment Diabetic Retinopathy Study, VA visual acuity
See this image and copyright information in PMC

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