Pro re nata take as needed cd pro#

if a patient shows no sign of an active disease (e.g.

In T&E regimens, the time interval of follow-up visits will be adjusted based on the patient’s clinical course-i.e. 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. In consequence, 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. Notably, by following such a PRN treatment protocol, injections are based on prior pathological OCT findings and, therefore, fall short of preventing the damaging yo-yo effect of retinal fluid accumulation.

Pro re nata take as needed cd pro#

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. Importantly, results of the pivotal phase III trials on the use of ranibizumab and aflibercept were based on regular, uninterrupted dosing protocols.

Ĭonsequently, there is still some uncertainty on the optimal treatment regimen that manages to balance all pros and cons optimally. Moreover, every single injection bears a small yet significant risk of endophthalmitis, a feared complication threatening eyesight, making any attempt of reducing injection frequency a crucial, patient-relevant objective. Thus, disease management, albeit highly effective, constitutes a high burden for patients and healthcare providers alike. Recent years have seen dramatic improvements in the therapeutic options of nvAMD, as anti-vascular endothelial growth factors (anti-VEGF), applied by intravitreal injection, inhibit development of these novel, aberrant blood vessels and the ensuing macular fluid leakage successfully.Īnti-VEGF treatment options have upended treatment of several retinal diseases, yet most notably of nvAMD, where treatment has to be applied often indefinitely and in short time intervals. NvAMD is characterized by leakage of fluid or blood into the macula, which severely affects central VA and may lead to legal blindness. Neovascular AMD (nvAMD), a subtype, may be associated with the development of defunct macular blood vessels. This large real-world data assessment supports previous data on the superiority of T&E treatment.Īge-related macular degeneration (AMD) is a common, chronic retinal disease that may cause dramatic impairment of visual acuity (VA). 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. 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. By comparison, logMAR improved more strongly in the ranibizumab/T&E group (16 to 0.2 logMAR) was higher in both T&E groups compared with the ranibizumab/PRN group. 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. At baseline, logMAR (mean ± SD) was similar in both ranibizumab treatment groups (PRN 0.63 ± 0.43, T&E 0.57 ± 0.42). In total, 1071 patients with 1332 treated eyes (ranibizumab/PRN 722, ranibizumab/T&E 191, aflibercept/T&E 419) were included in the analyses. Changes in logMAR and injection intervals (time between two injections) for specific treatment periods were evaluated descriptively and using mixed models. Treatment was performed according to local practices, using ranibizumab or aflibercept, and following T&E or PRN regimens. Patients diagnosed with age-related macular degeneration and without pre-treatment undergoing routine anti-VEGF treatment in one eye clinic in Switzerland were included. 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.