Abstract
PurposeTo 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.MethodsRetrospective, 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.ResultsIn 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.ConclusionsRanibizumab 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.
Highlights
Age-related macular degeneration (AMD) is a common, chronic retinal disease that may cause dramatic impairment of visual acuity (VA)
Results of the pivotal phase III trials on the use of ranibizumab and aflibercept were based on regular, uninterrupted dosing protocols. [2,3,4,5] As a first attempt to alleviate high treatment burden, the pro re nata (PRN) regimen was introduced, a treatment protocol where follow-up intervals remain fixed, while decisions to carry out an injection are based on the anatomic findings at each respective visit. [6,7,8] Notably, by following such a PRN treatment protocol, injections are based on prior pathological optical coherence tomography (OCT) findings and, fall short of preventing the damaging yo-yo effect of retinal fluid accumulation
Functional PRN results fared worse as compared with the pivotal phase III trials; in particular, initial VA gains could not be maintained as well during a longer follow-up time. [7,8,9] In order to develop a protocol with a reduced treatment burden, while at the same time ensuring timely treatment before any macular fluid accumulation occurs, another treatment regimen, the treat and extend (T&E) protocol, was developed
Summary
Age-related macular degeneration (AMD) is a common, chronic retinal disease that may cause dramatic impairment of visual acuity (VA). [2,3,4,5] As a first attempt to alleviate high treatment burden, the pro re nata (PRN) regimen was introduced, a treatment protocol where follow-up intervals remain fixed, while decisions to carry out an injection are based on the anatomic findings at each respective visit. [6,7,8] Notably, by following such a PRN treatment protocol, injections are based on prior pathological OCT findings and, fall short of preventing the damaging yo-yo effect of retinal fluid accumulation. In T&E regimens, the time interval of follow-up visits will be adjusted based on the patient’s clinical course—i.e. if a patient shows no sign of an active disease (e.g. the macula remains dry, without any leakage), intervals will be extended; if there is fluid accumulation, the interval will be shortened. Prior studies have shown efficacy of T&E, but are mostly still limited to smaller studies. [10,11,12,13,14,15] As pointed out by the American Academy of Ophthalmology, larger studies on the efficacy of T&E regimens are clearly warranted. [16]
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