Treatment of age-related macular degeneration with aflibercept using a treat, extend and fixed protocol; A 4-year study of treatment outcomes, durability, safety and quality of life (An extension to the MATE randomised controlled trial).
aflibercept
durability
neovascular age-related macular degeneration
quality of life
safety
Journal
Acta ophthalmologica
ISSN: 1755-3768
Titre abrégé: Acta Ophthalmol
Pays: England
ID NLM: 101468102
Informations de publication
Date de publication:
30 Sep 2023
30 Sep 2023
Historique:
revised:
05
07
2023
received:
19
02
2023
accepted:
18
09
2023
medline:
30
9
2023
pubmed:
30
9
2023
entrez:
30
9
2023
Statut:
aheadofprint
Résumé
Data are limited pertaining to the long-term benefits of aflibercept treatment for neovascular age-related macular degeneration (nAMD). The aim of this study was to provide outcomes, safety, durability and quality-of-life data with aflibercept using a modified treat, extend and fixed regime over 4 years. Prospective, multicentre, single cohort observational study of treatment-naïve nAMD participants treated with aflibercept as 2-year extension of the MATE-trial that compared early and late Treat-and-Extend for 2 years. Refracted ETDRS best corrected visual acuity (BCVA), central retinal thickness (CRT), treatment interval and adverse events were assessed. Quality-of-life was measured using the Macular Disease Dependent Quality of Life (MacDQoL) and Macular Disease Treatment Satisfaction Questionnaires (MacTSQ). Twenty-six of 40 participants completing the MATE-trial were enrolled with 20 completing the total 4-year study. Mean BCVA was 60.7 at Month 0 and 64.8 ETDRS letters at Month 48 while CRT decreased from 423.7 μm to 292.2 μm. Five participants discontinued treatment due to inactivity. The mean number of treatments and visits for the remaining participants was 27 and 30.0, respectively, with treatment intervals extended to 12 weeks in four participants at Month 48. Both AMD-specific QoL and treatment satisfaction remained stable between Months 0 and 48 and mean BCVA significantly correlated with AMD-specific QoL scores at Months 12, 24 and 48. Results suggest that BCVA can be maintained over 48 months when following a treat-extend-and-fix regimen of aflibercept with intervals out to 12 weeks, while maintaining AMD-specific QoL and treatment satisfaction.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Bayer PLC
ID : Investigator-led Independent grant
Informations de copyright
© 2023 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.
Références
Airody, A., Baseler, H.A., Seymour, J., Allgar, V., Mukherjee, R., Downey, L. et al. (2023) The MATE trial: a multicentre, mixed-methodology, pilot, randomised controlled trial in neovascular age-related macular degeneration. Pilot and Feasibility Studies, 9(1), 1-14. Available from: https://doi.org/10.1186/s40814-023-01288-0
Brown, D.M., Kaiser, P.K., Michels, M., Soubrane, G., Heier, J.S., Kim, R.Y. et al. (2006) Ranibizumab versus verteporfin for neovascular age-related macular degeneration. New England Journal of Medicine, 355(14), 1432-1444. Available from: https://doi.org/10.1056/NEJMoa062655
Chakravarthy, U., Harding, S.P., Rogers, C.A., Downes, S.M., Lotery, A.J., Culliford, L.A. et al. (2013) Alternative treatments to inhibit VEGF in age-related choroidal neovascularisation: 2-year findings of the IVAN randomised controlled trial. Lancet, 382(9900), 1258-1267. Available from: https://doi.org/10.1016/S0140-6736(13)61501-9
Dugel, P.U., Singh, R.P., Koh, A., Ogura, Y., Weissgerber, G., Gedif, K. et al. (2021) HAWK and HARRIER: Ninety-Six-week outcomes from the phase 3 trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology, 128(1), 89-99. Available from: https://doi.org/10.1016/j.ophtha.2020.06.028
Eleftheriadou, M., Gemenetzi, M., Lukic, M., Sivaprasad, S., Hykin, P.G., Hamilton, R.D. et al. (2018) Three-year outcomes of aflibercept treatment for neovascular age-related macular degeneration: evidence from a clinical setting. Ophthalmology and Therapy, 7(2), 361-368. Available from: https://doi.org/10.1007/s40123-018-0139-5
Finger, R.P., Guymer, R.H., Gillies, M.C. & Keeffe, J.E. (2014) The impact of anti-vascular endothelial growth factor treatment on quality of life in neovascular age-related macular degeneration. Ophthalmology, 121(6), 1246-1251. Available from: https://doi.org/10.1016/j.ophtha.2013.12.032
Finger, R.P., Wiedemann, P., Blumhagen, F., Pohl, K. & Holz, F.G. (2013) 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 Ophthalmologica, 91(6), 540-546. Available from: https://doi.org/10.1111/j.1755-3768.2012.02493.x
Freund, K.B., Korobelnik, J.F., Devenyi, R., Framme, C., Galic, J., Herbert, E. et al. (2015) Treat-and-extend regimens with anti-Vegf agents in retinal diseases. Retina, 35(8), 1489-1506. Available from: https://doi.org/10.1097/IAE.0000000000000627
Gale, R., Gill, C., Pikoula, M., Lee, A.Y., Hanson, R.L.W., Denaxas, S. et al. (2021) Multicentre study of 4626 patients assesses the effectiveness, safety and burden of two categories of treatments for central retinal vein occlusion: intravitreal anti-vascular endothelial growth factor injections and intravitreal Ozurdex injections. British Journal of Ophthalmology, 105(11), 1571-1576. Available from: https://doi.org/10.1136/bjophthalmol-2020-317306
Gayadine-Harricham, Y., Rufin, V., Law-Koune, S., Tran, T.H.C. & Dirani, A. (2020) Four-year outcome of aflibercept treatment-Naïve patients for neovascular age-related macular degeneration: evidence from a clinical setting. Journal of Ophthalmology, 2020, 1-7. Available from: https://doi.org/10.1155/2020/7465270
Hanson, R.L.W., Airody, A., Sivaprasad, S. & Gale, R.P. (2022) Optical coherence tomography imaging biomarkers associated with neovascular age-related macular degeneration: a systematic review. Eye, 37, 2438-2453. Available from: https://doi.org/10.1038/s41433-022-02360-4
Inoue, M., Arakawa, A., Yamane, S. & Kadonosono, K. (2014) Intravitreal injection of ranibizumab using a pro re nata regimen for age-related macular degeneration and vision-related quality of life. Clinical Ophthalmology, 8, 1711-1716. Available from: https://doi.org/10.2147/OPTH.S68293
Jaggi, D., Nagamany, T., Ebneter, A., Munk, M., Wolf, S. & Zinkernagel, M. (2022) Aflibercept for age-related macular degeneration: 4-year outcomes of a “treat-and-extend” regimen with exit-strategy. British Journal of Ophthalmology, 106(2), 246-250. Available from: https://doi.org/10.1136/bjophthalmol-2020-316514
Khanani, A.M., Patel, S.S., Ferrone, P.J., Osborne, A., Sahni, J., Grzeschik, S. et al. (2020) Efficacy of every four monthly and quarterly dosing of Faricimab vs ranibizumab in neovascular age-related macular degeneration: the STAIRWAY phase 2 randomized clinical trial. JAMA Ophthalmology, 138(9), 964-972. Available from: https://doi.org/10.1001/jamaophthalmol.2020.2699
Koh, A., Lanzetta, P., Lee, W.K., Lai, C.C., Chan, W.M., Yang, C.M. et al. (2017) Recommended guidelines for use of intravitreal aflibercept with a treat-and-extend regimen for the management of neovascular age-related macular degeneration in the Asia-pacific region: report from a consensus panel. Asia-Pacific Journal of Ophthalmology, 6(3), 296-302. Available from: https://doi.org/10.22608/APO.2016125
Krezel, A.K., Hogg, R.E. & Azuara-Blanco, A. (2015) Patient-reported outcomes in randomised controlled trials on age-related macular degeneration. British Journal of Ophthalmology, 99(11), 1560-1564. Available from: https://doi.org/10.1136/bjophthalmol-2014-306544
Lanzetta, P. & Loewenstein, A. (2017) Fundamental principles of an anti-VEGF treatment regimen: optimal application of intravitreal anti-vascular endothelial growth factor therapy of macular diseases. Graefe's Archive for Clinical and Experimental Ophthalmology, 255(7), 1259-1273. Available from: https://doi.org/10.1007/s00417-017-3647-4
Mitchell, J. & Bradley, C. (2004) Design of an individualised measure of the impact of macular disease on quality of life (the MacDQoL). Quality of Life Research, 13(6), 1163-1175. Available from: https://doi.org/10.1023/B:QURE.0000031348.51292.4a
Mitchell, J. & Bradley, C. (2006) Quality of life in age-related macular degeneration: a review of the literature. Health and Quality of Life Outcomes, 4, 1-20. Available from: https://doi.org/10.1186/1477-7525-4-97
Mitchell, J. & Bradley, C. (2018) Design and development of the MacTSQ measure of satisfaction with treatment for macular conditions used within the IVAN trial. Journal of Patient-Reported Outcomes, 2, 5. Available from: https://doi.org/10.1186/s41687-018-0031-z
Mitchell, J., Wolffsohn, J., Woodcock, A., Anderson, S.J., Ffytche, T., Rubinstein, M. et al. (2008) The MacDQoL individualized measure of the impact of macular degeneration on quality of life: reliability and responsiveness. American Journal of Ophthalmology, 146(3), 183-191. Available from: https://doi.org/10.1016/j.ajo.2008.04.031
Mitchell, P., Holz, F.G., Hykin, P., Midena, E., Souied, E., Allmeier, H. et al. (2021) 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 (Philadelphia, Pa.), 41(9), 1911-1920. Available from: https://doi.org/10.1097/IAE.0000000000003128
Nishikawa, K., Oishi, A., Hata, M., Miyake, M., Ooto, S., Yamashiro, K. et al. (2019) Four-year outcome of aflibercept for neovascular age-related macular degeneration and polypoidal choroidal vasculopathy. Scientific Reports, 9(1), 1-7. Available from: https://doi.org/10.1038/s41598-019-39995-5
Ohji, M., Takahashi, K., Okada, A.A., Kobayashi, M., Matsuda, Y., Terano, Y. et al. (2020) Efficacy and safety of intravitreal aflibercept treat-and-extend regimens in exudative age-related macular degeneration: 52- and 96-week findings from ALTAIR: a randomized controlled trial. Advances in Therapy, 37(3), 1173-1187. Available from: https://doi.org/10.1007/s12325-020-01236-x
Patel, P.J., Devonport, H., Sivaprasad, S., Ross, A.H., Walters, G., Gale, R.P. et al. (2017) Aflibercept treatment for neovascular AMD beyond the first year: consensus recommendations by a UK expert roundtable panel, 2017 update. Clinical Ophthalmology, 11, 1957-1966. Available from: https://doi.org/10.2147/OPTH.S145732
Poku, E., Brazier, J., Carlton, J. & Ferreira, A. (2013) Health state utilities in patients with diabetic retinopathy, diabetic macular oedema and age-related macular degeneration: a systematic review. BMC Ophthalmology, 13(1), 1-13. Available from: https://doi.org/10.1186/1471-2415-13-74
Rosenfeld, P.J., Brown, D.M., Heier, J.S., Boyer, D.S., Kaiser, P.K., Chung, C.Y. et al. (2006) Ranibizumab for neovascular age-related macular degeneration. New England Journal of Medicine, 355(14), 1419-1431. Available from: https://doi.org/10.1056/NEJMoa054481
Ross, A.H., Downey, L., Devonport, H., Gale, R.P., Kotagiri, A., Mahmood, S. et al. (2020) Recommendations by a UK expert panel on an aflibercept treat-and-extend pathway for the treatment of neovascular age-related macular degeneration. Eye (Basingstoke), 34(10), 1825-1834. Available from: https://doi.org/10.1038/s41433-019-0747-x
Schmidt-Erfurth, U., Kaiser, P.K., Korobelnik, J.F., Brown, D.M., Chong, V., Nguyen, Q.D. et al. (2014) Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology, 121(1), 193-201. Available from: https://doi.org/10.1016/j.ophtha.2013.08.011
Taylor, D.J., Hobby, A.E., Binns, A.M. & Crabb, D.P. (2016) How does age-related macular degeneration affect real-world visual ability and quality of life? A systematic review. BMJ Open, 6(12), 1-13. Available from: https://doi.org/10.1136/bmjopen-2016-011504
Tosh, J., Brazier, J., Evans, P. & Longworth, L. (2012) A review of generic preference-based measures of health-related quality of life in visual disorders. Value in Health, 15(1), 118-127. Available from: https://doi.org/10.1016/j.jval.2011.08.002
Wang, L.L., Liu, W.J., Liu, H.Y. & Xu, X. (2015) Single-site baseline and short-term outcomes of clinical characteristics and life quality evaluation of Chinese wet age-related macular degeneration patients in routine clinical practice. Chinese Medical Journal, 128(9), 1154-1159. Available from: https://doi.org/10.4103/0366-6999.156083