PERSEUS-IT 24-month analysis: a prospective observational study to assess the effectiveness of intravitreal aflibercept in routine clinical practice in Italy in patients with neovascular age-related macular degeneration

Massimo Nicolò, Francesco Ciucci, Marco Nardi, Barbara Parolini, Andrea Russo, Andrea Scupola, Salvatore Torregrossa, Maria Vadalà, PERSEUS-IT study investigators, Massimo Nicolò, Francesco Ciucci, Marco Nardi, Barbara Parolini, Andrea Russo, Andrea Scupola, Salvatore Torregrossa, Maria Vadalà, PERSEUS-IT study investigators

Abstract

Purpose: PERSEUS-IT (NCT02289924) was a prospective, observational, 2-year study evaluating the effectiveness and treatment patterns of intravitreal aflibercept (IVT-AFL) in patients with neovascular age-related macular degeneration (nAMD) in routine clinical practice in Italy.

Methods: Treatment-naïve patients with nAMD receiving IVT-AFL per routine clinical practice were enrolled. The primary endpoint was mean change in visual acuity (VA; decimals) from baseline to month (M) 12 and M24. Outcomes were evaluated for the overall study population and independently for the 2 treatment cohorts: regular (3 initial monthly doses, ≥ 7 injections by M12, and ≥ 4 injections between M12 and M24) and irregular (any other pattern).

Results: Of 813 patients enrolled, 709 were included in the full analysis set (FAS); VA assessments were available for 342 patients at M12 (FAS1Y, 140 regular and 202 irregular) and 233 patients at M24 (FAS2Y, 37 regular and 196 irregular). In the overall FAS, the mean ± SD change in VA from baseline to M12 and M24 was + 0.09 ± 0.24 and + 0.02 ± 0.25 decimals, and there was a statistically significant difference between the regular and irregular cohorts in both FAS1Y (p = 0.0034) and FAS2Y (p = 0.0222). Ocular treatment-emergent adverse events were reported in 4.1% (n = 33/810 [safety set]) of patients.

Conclusion: In PERSEUS-IT, clinically relevant functional and anatomic improvements were observed within the first 12 months of IVT-AFL treatment in routine clinical practice in Italy in patients with treatment-naïve nAMD. These gains were generally maintained across the 2-year study. The safety profile of IVT-AFL was consistent with prior studies.

Trial registration number: ClinicalTrials.gov Identifier: NCT02289924.

Date of registration: November 13, 2014.

Keywords: Aflibercept; Intravitreal injections; Neovascular age-related macular degeneration; Observational study; Treatment outcomes.

Conflict of interest statement

MV received consulting fees from Bayer Italia S.p.A., Novartis Italia S.p.A, and Allergan Italia S.p.A. outside the scope of the submitted work. The remaining authors have no competing interests to declare.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Trend in VA from baseline. a Absolute mean VA for the overall FAS over 24 months, b least square mean VA from baseline to month 12 for the FAS1Y by regular and irregular cohort, and c least square mean VA from baseline to month 24 for the FAS2Y by regular and irregular cohort. BL, baseline; FAS, full analysis set; FAS1Y, year 1 FAS; FAS2Y, year 2 FAS; VA, visual acuity
Fig. 2
Fig. 2
Mean change in CRT from baseline to month 24 for the overall FAS. CRT was not recorded for all patients for whom optical coherence tomography was performed. BL, baseline; CRT, central retinal thickness; FAS, full analysis set

References

    1. Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, Ho AC, Ogura Y, Simader C, Jaffe GJ, Slakter JS, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Sowade O, Zeitz O, Norenberg C, Sandbrink R, Heier JS. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014;121(1):193–201. doi: 10.1016/j.ophtha.2013.08.011.
    1. Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;355(14):1432–1444. doi: 10.1056/NEJMoa062655.
    1. Mitchell P, Holz FG, Hykin P, Midena E, Souied E, Allmeier H, Lambrou G, Schmelter T, Wolf S. Efficacy and safety of intravitreal aflibercept using a treat-and-extend regimen for neovascular age-related macular degeneration: the ARIES study: a randomized clinical trial. Retina. 2021;41(9):1911–1920. doi: 10.1097/IAE.0000000000003128.
    1. Ohji M, Takahashi K, Okada AA, Kobayashi M, Matsuda Y, Terano Y. Efficacy and safety of intravitreal aflibercept treat-and-extend regimens in exudative age-related macular degeneration: 52- and 96-week findings from ALTAIR. Adv Ther. 2020;37(3):1173–1187. doi: 10.1007/s12325-020-01236-x.
    1. Silva R, Berta A, Larsen M, Macfadden W, Feller C, Monés J, TREND Study Group Treat-and-extend versus monthly regimen in neovascular age-related macular degeneration: results with ranibizumab from the TREND study. Ophthalmology. 2018;125(1):57–65. doi: 10.1016/j.ophtha.2017.07.014.
    1. Dugel PU, Singh RP, Koh A, Ogura Y, Weissgerber G, Gedif K, Jaffe GJ, Tadayoni R, Schmidt-Erfurth U, Holz FG. HAWK and HARRIER: ninety-six-week outcomes from the phase 3 trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2021;128(1):89–99. doi: 10.1016/j.ophtha.2020.06.028.
    1. Okada M, Mitchell P, Finger RP, Eldem B, Talks SJ, Hirst C, Paladini L, Barratt J, Wong TY, Loewenstein A. Non-adherence or non-persistence to intravitreal injection therapy for neovascular age-related macular degeneration: a mixed-methods systematic review. Ophthalmology. 2021;128(2):234–247. doi: 10.1016/j.ophtha.2020.07.060.
    1. Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Cortez R, Hoyng CB, Hykin P, Staurenghi G, Heldner S, Bogumil T, Heah T, Sivaprasad S. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015;99(2):220–226. doi: 10.1136/bjophthalmol-2014-305327.
    1. Framme C, Eter N, Hamacher T, Hasanbasic Z, Jochmann C, Johnson KT, Kahl M, Sachs H, Schilling H, Thelen U, Wiedemann P, Wachtlin J. Aflibercept for patients with neovascular age-related macular degeneration in routine clinical practice in Germany: twelve-month outcomes of PERSEUS. Ophthalmol Retina. 2018;2(6):539–549. doi: 10.1016/j.oret.2017.09.017.
    1. Eter N, Hasanbasic Z, Keramas G, Rech C, Sachs H, Schilling H, Wachtlin J, Wiedemann P, Framme C. PERSEUS 24-month analysis: a prospective non-interventional study to assess the effectiveness of intravitreal aflibercept in routine clinical practice in Germany in patients with neovascular age-related macular degeneration. Graefe's Arch Clin Exp Ophthalmol. 2021;259(8):2213–2223. doi: 10.1007/s00417-021-05073-8.
    1. Weber M, Kodjikian L, Coscas F, Faure C, Aubry I, Dufour I, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration in routine clinical practice in France: results from the RAINBOW study. BMJ Open Ophthalmol. 2020;5(1):e000377. doi: 10.1136/bmjophth-2019-000377.
    1. Weber M, Dominguez M, Coscas F, Faure C, Baillif S, Kodjikian L, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration: 2-year results of RAINBOW. BMC Ophthalmol. 2020;20(1):206. doi: 10.1186/s12886-020-01468-z.
    1. Weber M, Velasque L, Coscas F, Faure C, Aubry I, Cohen SY. Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study. BMJ Open Ophthalmol. 2019;4(1):e000109. doi: 10.1136/bmjophth-2017-000109.
    1. Arrigo A, Saladino A, Aragona E, Mercuri S, Introini U, Bandello F, Parodi MB. Different outcomes of anti-VEGF treatment for neovascular AMD according to neovascular sutypes and baseline features: 2-year real-life clinical outcomes. Biomed Res Int. 2021;2021:5516981. doi: 10.1155/2021/5516981.
    1. Gharbiya M, Iannetti L, Parisi F, De Vico U, Mungo ML, Marenco M. Visual and anatomical outcomes of intravitreal aflibercept for treatment-resistant neovascular age-related macular degeneration. Biomed Res Int. 2014;2014:273754. doi: 10.1155/2014/273754.
    1. Kiernan DF, Hariprasad SM, Chin EK, Kiernan CL, Rago J, Mieler WF. Prospective comparison of cirrus and stratus optical coherence tomography for quantifying retinal thickness. Am J Ophthalmol. 2009;147(2):267–275. doi: 10.1016/j.ajo.2008.08.018.
    1. Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U, VEIW 1 and VIEW 2 Study Groups Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537–2548. doi: 10.1016/j.ophtha.2012.09.006.
    1. Almuhtaseb H, Johnston RL, Talks JS, Lotery AJ. Second-year visual acuity outcomes of nAMD patients treated with aflibercept: data analysis from the UK Aflibercept Users Group. Eye (Lond) 2017;31(11):1582–1588. doi: 10.1038/eye.2017.108.
    1. Mitchell P, Rodríguez FJ, Joussen AM, Koh A, Eter N, Wong DT, Korobelnik JF, Okada AA. Management of retinal pigment epithelium tear during anti-vascular endothelial growth factor therapy. Retina. 2021;41(4):671–678. doi: 10.1097/IAE.0000000000003083.
    1. Schmidt-Erfurth U, Chong V, Loewenstein A, Larsen M, Souied E, Schlingemann R, Eldem B, Monés J, Richard G, Bandello F, European, Society of Retina Specialists Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA) Br J Ophthalmol. 2014;98(9):1144–1167. doi: 10.1136/bjophthalmol-2014-305702.
    1. Scondotto G, Sultana J, Ientile V, Ingrasciotta Y, Fontana A, Copetti M, Mirabelli E, Trombetta CJ, Rapisarda C, Reibaldi M, Avitabile T, Longo A, Toro PI, Vadalà M, Cillino S, Virgili G, Gini R, Leoni O, Pollina Addario SW, Cananzi P, La Cavera C, Puzo MR, De Sarro G, De Francesco A, Trifirò G. How have intravitreal anti-VEGF and dexamethasone implant been used in Italy? A multiregional, population-based study in the years 2010–2016. Biomed Res Int. 2020;2020:7582763. doi: 10.1155/2020/7582763.
    1. Lim JH, Wickremasinghe SS, Xie J, Chauhan DS, Baird PN, Robman LD, Hageman G, Guymer RH. Delay to treatment and visual outcomes in patients treated with anti-vascular endothelial growth factor for age-related macular degeneration. Am J Ophthalmol. 2012;153(4):678–686, 686.e1-2. doi: 10.1016/j.ajo.2011.09.013.
    1. Arias L, Armadá F, Donate J, García-Arumí J, Giralt J, Pazos B, Piñero A, Martinez F, Mondéjar JJ, Ortega I, Zlateva G, Buggage R. Delay in treating age-related macular degeneration in Spain is associated with progressive vision loss. Eye (Lond) 2009;23(2):326–333. doi: 10.1038/sj.eye.6703053.
    1. Lovie-Kitchin JE. Is it time to confine Snellen charts to the annals of history? Ophthalmic Physiol Opt. 2015;35(6):631–636. doi: 10.1111/opo.12252.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj