Name

Comparaison des stratégies pro re nata et treat and extend dans la dégénérescence maculaire liée à l’âge exsudative : une étude de non-infériorité

Age-related macular degeneration (AMD) accounts for 5% of all blindness worldwide. The introduction of anti-vascular endothelial growth factor (anti-VEGF) therapy has revolutionized the management for neovascular AMD (nAMD). Our objective is to prove non-inferiority between two different treatment regimens (pro-re-nata (PRN) and treat and extend (T&E)) using every available anti-VEGF treatment in France.

A two-year prospective open-label, monocentric study conducted in the Department of Ophthalmology of the University Hospital of Besançon in France randomized not naïve T&E and PRN treated patients for nAMD with anti-VEGF in two groups. The primary objective was to compare the effectiveness of two treatment regimens by assessing the mean change in best corrected visual acuity (BCVA) (ETDRS letters) from baseline to month 24. A non-inferiority margin of -4 letters was applied. Secondary outcomes were central retinal thickness (CRT) and number of intravitreal injection (IVI) progression.

A total of 124 eyes received the T&E (n=61) or PRN (n=63) regimen. Patient demographic and baseline ocular characteristics were well balanced between the two treatment groups. At month 24, the mean BCVA change from baseline was -4.4 ETDRS letters in the T&E group and -3.4 ETDRS letters in the PRN group (last observation carried forward (LOCF) method). The mean difference between the treatment groups was +1.1 ETDRS letters (95% CI [-2.25]; p = 0.006). The mean change in CRT (LOCF method) was -10.6 µm (T&E) and -7.9 µm (PRN) with a mean difference of +2.6 µm (95% CI [+19.2]; p = 0.004). The mean number of injections received (per protocol analysis) was 15.5 and 10.9 injections respectively at month 24 with a mean of +4.6 more injections in the T&E group (95% CI [-7.06; -2.12]; p < 0.001).

In the current study, we demonstrated that eyes previously treated for nAMD for several years did not benefit of a treatment regimen switch from PRN to T&E, neither in terms of visual nor anatomical outcomes in a setting close to a real-life practice. T&E regimen did reduce by one-third the number of visits during the 24-month study duration but necessitated four additional injections. Non-inferiority between T&E and PRN was demonstrated in both visual and anatomical outcomes. In both groups, visual acuity declined moderately over the two year-course of the study.

Non-inferiority between PRN and T&E regimen in visual and anatomical outcomes is statistically proven until 24 months with significantly more IVI in the T&E regimen. The decision to switch from PRN to T&E should be based on practical consideration such as reducing the burden of the frequent visits rather than targeting a better visual or anatomical outcome.