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To investigate treat and extend versus pro re nata regimen in neovascular age-related macular degeneration: results from the IDEM study

  • Retinal Disorders
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Abstract

Purpose

The purpose of this study is to report the 24-month outcomes of a pro re nata (PRN) compared with a treat and extend (T&E) regimen in patients previously treated for neovascular age-related macular degeneration (nAMD).

Methods

This was a 2-year prospective, single-center study. Previously treated patients for nAMD were randomized into two regimen groups: T&E and PRN groups. Main outcome measured was change in best corrected visual acuity (BCVA) from baseline to month 24. Secondary outcomes encompassed anatomical features such as central retinal thickness (CRT), number of intravitreal injections (IVI), and visits required.

Results

A total of 124 eyes received the T&E (n = 61) or PRN (n = 63) regimen. At month 24, the mean BCVA change was −4.4 early treatment diabetic retinopathy study (ETDRS) letters (T&E) and −3.4 ETDRS letters (PRN), with a difference of +1.1 ETDRS letters (95% CI [−2.25]; p = 0.006). The mean change in CRT was −10.6 µm (T&E) and −7.9 µm (PRN), with a difference of +2.6 µm (95% CI [+19.2]; p = 0.004). The T&E group had received a mean of +4.6 more injections (95% CI [−7.06; −2.12]; p < 0.001) at month 24.

Conclusion

There was statistically proven non-inferiority between the PRN and T&E regimens in terms of visual and anatomical outcomes at 24 months, with significantly more IVI administered in the T&E regimen.

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References

  1. Pascolini D, Mariotti SP (2012) Global estimates of visual impairment: 2010. Br J Ophthalmol 96:614–618. https://doi.org/10.1136/bjophthalmol-2011-300539

    Article  PubMed  Google Scholar 

  2. Rosenfeld PJ, Brown DM, Heier JS et al (2006) Ranibizumab for neovascular age-related macular degeneration. N Engl J Med 355:1419–1431. https://doi.org/10.1056/NEJMoa054481

    Article  CAS  PubMed  Google Scholar 

  3. Brown DM, Kaiser PK, Michels M et al (2006) Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med 355:1432–1444. https://doi.org/10.1056/NEJMoa062655

    Article  CAS  PubMed  Google Scholar 

  4. Holz FG, Tadayoni R, Beatty S et al (2015) Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol 99:220–226. https://doi.org/10.1136/bjophthalmol-2014-305327

    Article  PubMed  Google Scholar 

  5. Holz FG, Amoaku W, Donate J et al (2011) Safety and efficacy of a flexible dosing regimen of ranibizumab in neovascular age-related macular degeneration: the SUSTAIN study. Ophthalmology 118:663–671. https://doi.org/10.1016/j.ophtha.2010.12.019

    Article  PubMed  Google Scholar 

  6. Lalwani GA, Rosenfeld PJ, Fung AE et al (2009) A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the PrONTO Study. Am J Ophthalmol 148:43-58.e1. https://doi.org/10.1016/j.ajo.2009.01.024

    Article  CAS  PubMed  Google Scholar 

  7. Spaide R (2007) Ranibizumab according to need: a treatment for age-related macular degeneration. Am J Ophthalmol 143:679–680. https://doi.org/10.1016/j.ajo.2007.02.024

    Article  PubMed  Google Scholar 

  8. Engelbert M, Zweifel SA, Freund KB (2010) Long-term follow-up for type 1 (subretinal pigment epithelium) neovascularization using a modified “treat and extend” dosing regimen of intravitreal antivascular endothelial growth factor therapy. Retina (Philadelphia, Pa) 30:1368–1375. https://doi.org/10.1097/IAE.0b013e3181d50cbf

    Article  Google Scholar 

  9. Chin-Yee D, Eck T, Fowler S et al (2016) A systematic review of as needed versus treat and extend ranibizumab or bevacizumab treatment regimens for neovascular age-related macular degeneration. Br J Ophthalmol 100:914–917. https://doi.org/10.1136/bjophthalmol-2015-306987

    Article  PubMed  Google Scholar 

  10. Shah GK, Stone TW (eds) (2017) Global trends in retina survey: Chicago, IL. American Society of Retina Specialists.

  11. Gillies MC, Walton RJ, Arnold JJ et al (2014) Comparison of outcomes from a phase 3 study of age-related macular degeneration with a matched, observational cohort. Ophthalmology 121:676–681. https://doi.org/10.1016/j.ophtha.2013.09.050

    Article  PubMed  Google Scholar 

  12. Guymer RH, Markey CM, McAllister IL et al (2019) Tolerating subretinal fluid in neovascular age-related macular degeneration treated with ranibizumab using a treat-and-extend regimen: FLUID study 24-month results. Ophthalmology 126:723–734. https://doi.org/10.1016/j.ophtha.2018.11.025

    Article  PubMed  Google Scholar 

  13. Heier JS, Brown DM, Chong V et al (2012) Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology 119:2537–2548. https://doi.org/10.1016/j.ophtha.2012.09.006

    Article  PubMed  Google Scholar 

  14. Grunwald JE, Daniel E, Huang J et al (2014) Risk of geographic atrophy in the comparison of age-related macular degeneration treatments trials. Ophthalmology 121:150–161. https://doi.org/10.1016/j.ophtha.2013.08.015

    Article  PubMed  Google Scholar 

  15. Mathalone N, Arodi-Golan A, Sar S et al (2012) Sustained elevation of intraocular pressure after intravitreal injections of bevacizumab in eyes with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol 250:1435–1440. https://doi.org/10.1007/s00417-012-1981-0

    Article  CAS  PubMed  Google Scholar 

  16. Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group, Martin DF, Maguire MG et al (2012) Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results. Ophthalmology 119:1388–1398. https://doi.org/10.1016/j.ophtha.2012.03.053

    Article  Google Scholar 

  17. Cohen SY, Mimoun G, Oubraham H et al (2013) Changes in visual acuity in patients with wet age-related macular degeneration treated with intravitreal ranibizumab in daily clinical practice: the LUMIERE study. Retina (Philadelphia, Pa) 33:474–481. https://doi.org/10.1097/IAE.0b013e31827b6324

    Article  CAS  Google Scholar 

  18. Kim LN, Mehta H, Barthelmes D et al (2016) Metaanalysis of real-world outcomes of intravitreal ranibizumab for the treatment of neovascular age-related macular degeneration. Retina (Philadelphia, Pa) 36:1418–1431. https://doi.org/10.1097/IAE.0000000000001142

    Article  CAS  Google Scholar 

  19. Monés J, Singh RP, Bandello F et al (2020) Undertreatment of neovascular age-related macular degeneration after 10 years of anti-vascular endothelial growth factor therapy in the real world: the need for a change of mindset. Ophthalmologica 243:1–8. https://doi.org/10.1159/000502747

    Article  PubMed  Google Scholar 

  20. Silva R, Berta A, Larsen M et al (2018) Treat-and-extend versus monthly regimen in neovascular age-related macular degeneration: results with ranibizumab from the TREND study. Ophthalmology 125:57–65. https://doi.org/10.1016/j.ophtha.2017.07.014

    Article  PubMed  Google Scholar 

  21. Wykoff CC, Croft DE, Brown DM et al (2015) Prospective trial of treat-and-extend versus monthly dosing for neovascular age-related macular degeneration: TREX-AMD 1-year results. Ophthalmology 122:2514–2522. https://doi.org/10.1016/j.ophtha.2015.08.009

    Article  PubMed  Google Scholar 

  22. Ohji M, Takahashi K, Okada AA 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. Adv Ther 37:1173–1187. https://doi.org/10.1007/s12325-020-01236-x

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  23. Berg K, Pedersen TR, Sandvik L, Bragadóttir R (2015) Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to LUCAS treat-and-extend protocol. Ophthalmology 122:146–152. https://doi.org/10.1016/j.ophtha.2014.07.041

    Article  PubMed  Google Scholar 

  24. Barthelmes D, Nguyen V, Daien V et al (2018) Two year outcomes of “treat and extend” intravitreal therapy using aflibercept preferentially for neovascular age-related macular degeneration. Retina (Philadelphia, Pa) 38:20–28. https://doi.org/10.1097/IAE.0000000000001496

    Article  CAS  Google Scholar 

  25. Kim JH (2020) Results of switching from pro re nata to treat-and-extend regimen in treatment of patients with type 3 neovascularization. Seminars in Ophthalmology 35:33–40. https://doi.org/10.1080/08820538.2019.1701045

    Article  PubMed  Google Scholar 

  26. Kvannli L, Krohn J (2017) Switching from pro re nata to treat-and-extend regimen improves visual acuity in patients with neovascular age-related macular degeneration. Acta Ophthalmol 95:678–682. https://doi.org/10.1111/aos.13356

    Article  CAS  PubMed  Google Scholar 

  27. Johnston RL, Carius H-J, Skelly A et al (2017) A Retrospective study of ranibizumab treatment regimens for neovascular age-related macular degeneration (nAMD) in Australia and the United Kingdom. Adv Ther 34:703–712. https://doi.org/10.1007/s12325-017-0483-1

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  28. Brown DM, Tuomi L, Shapiro H, Pier Study Group (2013) Anatomical measures as predictors of visual outcomes in ranibizumab-treated eyes with neovascular age-related macular degeneration. Retina (Philadelphia, Pa) 33:23–34. https://doi.org/10.1097/IAE.0b013e318263cedf

    Article  CAS  Google Scholar 

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Correspondence to Maher Saleh.

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Ethics approval

The ethical committee of the Besancon University Hospital (Bourgogne & Franche-Comté University) approved the study.

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The authors declare no competing interests.

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Summary statement

Treat and extend regimen is a popular treatment strategy for neovascular age-related macular degeneration. However, data on the efficacy of a regimen switch are limited in patients already treated according to a pro re nata regimen. At 24 months, the non-inferiority of the pro re nata regimen was demonstrated in previously treated patients.

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Faudi, E., Gauthier, AS., Delbosc, B. et al. To investigate treat and extend versus pro re nata regimen in neovascular age-related macular degeneration: results from the IDEM study. Graefes Arch Clin Exp Ophthalmol 260, 2149–2156 (2022). https://doi.org/10.1007/s00417-021-05543-z

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  • DOI: https://doi.org/10.1007/s00417-021-05543-z

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