Treat and extend versus pro re nata regimens of ranibizumab and aflibercept in neovascular age-related macular degeneration: a comparative study

Abstract

Purpose To compare treatment efficacy of anti-VEGF medications following pro re nata (PRN, "as needed", monthly injections only in case of active disease) or treat and extend (T&E, progressive extension of treatment intervals up to 12 weeks depending on the clinical findings) treatment protocols in real-world conditions. Methods Retrospective, observational study. Patients diagnosed with age-related macular degeneration and without pre-treatment undergoing routine anti-VEGF treatment in one eye clinic in Switzerland were included. Treatment was performed according to local practices, using ranibizumab or aflibercept, and following T&E or PRN regimens. Changes in logMAR and injection intervals (time between two injections) for specific treatment periods were evaluated descriptively and using mixed models. Results In total, 1071 patients with 1332 treated eyes (ranibizumab/PRN 722, ranibizumab/T&E 191, aflibercept/T&E 419) were included in the analyses. At baseline, logMAR (mean ± SD) was similar in both ranibizumab treatment groups (PRN 0.63 ± 0.43, T&E 0.57 ± 0.42). In the ranibizumab/PRN group, logMAR was about 0.1 lower for all time intervals in the initial and maintenance phases in comparison with baseline, indicating an improvement in VA. By comparison, logMAR improved more strongly in the ranibizumab/T&E group (16 to < 22 months, − 0.19 [− 0.23-0.15]) in comparison with baseline. Comparing ranibizumab/T&E vs. aflibercept/T&E groups, improvements in logMAR were similar over time. In the maintenance phase, the rate of patients with a clinically relevant improvement in visual acuity (> 0.2 logMAR) was higher in both T&E groups compared with the ranibizumab/PRN group. Injection intervals in the maintenance phase in ranibizumab/T&E group gradually expanded over time; whereas in the aflibercept/T&E group, injection intervals remained relatively stable. Conclusions Ranibizumab used according to T&E protocol yielded a stronger improvement in logMAR, compared with PRN protocol with longer injection intervals than aflibercept/T&E. This large real-world data assessment supports previous data on the superiority of T&E treatment. Keywords Age-related macular degeneration (AMD). Pro re nata (PRN). Treat and extend (T&E). Anti-VEGF treatment .

Long-Term Outcomes of Switching from Fixed-Dose to As-Needed Regimen for Treating Submacular Hemorrhage Secondary to Polypoidal Choroidal Vasculopathy

“…In an early clinical trial, an as-needed regimen led to a similar visual outcome with markedly fewer injections compared with a fixed-dose regimen [19]. However, recent studies have suggested that the visual outcome of an as-needed regimen is generally inferior to proactive treatment regimens such as fixed-dose [26] or treat-and-extend [20,27] regimens. Intravitreal anti-VEGF injection imposes a substantial financial and time burden on the patient [28,29] and is frequently associated with pain and anxiety [30,31].…”

Treatment algorithm with dexamethasone intravitreal implant in patients with diabetic macular edema

“…Since it requires many clinical visits and frequent injections, different treatment regimens have been discussed, from monthly treatment to pro re nata (treatment when needed) and treat and extend (T&E), a proactive treatment regimen where injection is given at every follow-up visit with extended intervals. In the treatment of wet AMD, T&E regimen has been shown to be superior to other regimens with a better visual outcome despite fewer injections (Augsburger et al 2019).…”

Saudi Arabia Guidelines for diabetic macular edema

“…We prefer the TE strategy due to the high cost of the monthly visit, difficulty for some old patients, and better results of TE shown in real-world practice. 118 The experts' panel stipulated that the following criteria define the improvement of anti-VEGF treatment: if VA improved by more than 5 letters or the central subfield thickness on OCT improved by more than 20% since the last assessment before treatment as per the protocol I. 107 The experts' panel stipulated that the following criteria define non-responders to anti-VEGF: signs of massive edema, reduction of <20% in CRT or macular volume, and no or <5 letter improvement in VA after initial loading course (as per protocol I sub-analysis).…”