Abstract
BackgroundIntravitreal injections are a mandatory treatment for macular edema due to nAMD, DME and RVO. These chronic diseases usually need chronic treatment using intravitreal injections with anti-VEGF agents. Thus, many trials were performed to define the best treatment interval using pro re nata regimes (PRN), fixed regimes or treat-and-extend regimes (TE). However, real-world studies reveal a high rate of losing patients within a 2-year interval of treatment observation causing worse results. In this study we analyzed retrospectively 2 years of real-world experience with an individualized treat-and-extend injection scheme.MethodsSince 2015 our treatment scheme for intravitreal injections has been switched from PRN to TE. Out of 102 patients 59 completed a follow up time of 2 years. Every patient received visual acuity testing, SD-OCT and slit lamp examination prior to every injection. At each visit an injection was performed and the treatment interval was adjusted mainly on SD-OCT based morphologic changes by increasing or reducing in 2-week steps. Individual changes of the treatment protocol by face-to-face communication between physician and patient were possible.ResultsAfter 1 year of treatment visual acuity gain in nAMD was 7.4 ± 2.2 ETDRS letters (n = 34; injection frequency: 7.4 ± 0.4) respectively 6.1 ± 4.7 in DME (n = 9; injection frequency: 8.4 ± 1.1) and 9.7 ± 4.5 in RVO (n = 16; injection frequency: 7.6 ± 0.5). After 2 years of treatment results were as following: nAMD: visual acuity gain 6.9 ± 2.1 (injection frequency: 12.6 ± 0.7); DME: 11.1 ± 5.1 (injection frequency: 14.0 ± 1.0); RVO: 7.5 ± 5.0 (injection frequency: 11.2 ± 0.9). Planned treatment exit after 2 year was achieved in 29.4% of patients in nAMD (0% after 1 year); 0% in DME (0% after 1 year); and 31.3% in RVO (0% after 1 year). Patients’ persistence was 94.1% during the follow-up.ConclusionUsing a consequent and individualized TE regime in daily practice may lead to a high patients’ persistence and visual acuity gains nearly comparable to those of large prospective clinical trials. Crucial factors are face-to-face communication with the patient as well as a stringent management regime. At this time TE may be the only instrument for proactive therapy which should therefore be regarded as a first-line tool in daily practice.
Highlights
Intravitreal injections are a mandatory treatment for macular edema due to Neovascular age related macular disease (nAMD), diabetic macular edema (DME) and retinal vein occlusion (RVO)
Since Ranibizumab therapy was introduced in Europe as a pro re nata regime (PRN) starting with three injections at 4-week intervals, it has taken several years to learn, that in real world patients were not optimally treated
In 2015 treatment strategy was switched from pro re nata regimes (PRN) to treat-and-extend regimes (TE) for all three main macular diseases as nAMD, DME and RVO
Summary
Intravitreal injections are a mandatory treatment for macular edema due to nAMD, DME and RVO. Real-world studies reveal a high rate of losing patients within a 2-year interval of treatment observation causing worse results. Since the start in treating nAMD with VEGF-inhibitors on an on-label base in the year 2006 using Ranibizumab many studies have been performed to evaluate the best injection frequency and optimal exit strategies. Since Ranibizumab therapy was introduced in Europe as a pro re nata regime (PRN) starting with three injections at 4-week intervals, it has taken several years to learn, that in real world patients were not optimally treated. The real world observational German PERSEUS study using Aflibercept showed, that injection frequency and adequate continuous treatment is important to achieve stable visual gains [8]. Other real-world observational studies as AURA [7] and WAVE [9] showed same insufficient results in treating nAMD on a continuous base
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