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