Abstract
PurposePatients with neovascular age-related macular degeneration (nARMD) will not deteriorate on visual acuity and retinal thickness when treated with bevacizumab injection frequencies of 6 or 8 weeks compared to 4 weeks. This study aimed to investigate this non-inferiority in quality of life (QoL). We hypothesized that less frequent bevacizumab injections are not inferior regarding patients reported QoL.MethodsPatients were randomized to bevacizumab every 4 (n = 64), 6 (n = 63), and 8 weeks (n = 64). Patients were at least 65 years old, have a best-corrected visual acuity of 20/200 to 20/20, no previous ARMD treatment and active leakage. Vision-related QoL questionnaire NEI VFQ-39 was used to assess QoL at baseline and after 1 year. General QoL questionnaire SF-36 was included for secondary analysis. Multilevel analyses were performed, correcting for age, gender and baseline.ResultsThe 6 (3.68; 95% CI − 0.63 to 8.00) and 8 (2.15; 95% CI − 2.26 to 6.56) weeks bevacizumab regimens resulted in non-inferior QoL differences compared to 4 weeks on the NEI VFQ-39. Also on the SF-36 the differences were well within the non-inferiority limits.ConclusionNon-inferiority of the 6 and 8 weeks frequencies was demonstrated compared to 4 weeks on vision-related and general QoL in patients with nARMD. These results are in line with previously published results of lower frequency injections regarding visual acuity and central retinal thickness. Lower injection frequency may reduce burden, side effects, and treatment costs. In consideration of these results, 8 weeks frequency injections of intravitreal bevacizumab could be considered in patients with nARMD.
Highlights
Age-related macular degeneration (ARMD) is the leading cause of severe vision loss and blindness among people aged over 50 years in Western countries [1, 2]
Bevacizumab has been approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of various tumors, such as colorectal cancer [14], but not for neovascular age-related macular degeneration (nARMD)
The IVAN study showed similar results on QoL for bevacizumab and ranibizumab measured with the EuroQol-5D [21], macular disease-specific quality of life [22] and treatment satisfaction [23]
Summary
Age-related macular degeneration (ARMD) is the leading cause of severe vision loss and blindness among people aged over 50 years in Western countries [1, 2]. Since there is interest in the patients’ perspective of satisfaction, in terms of outcome, several patient-reported outcome measures (PROMs). Several studies have suggested that the use of PROMs have a positive effect on the doctor-patient communication, and patients’ satisfaction [7]. The efficacy of ranibizumab and aflibercept has been proven and appear clinically equivalent, and are approved both by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for intraocular use in nARMD [8,9,10,11,12,13]. The IVAN study showed similar results on QoL for bevacizumab and ranibizumab measured with the EuroQol-5D [21], macular disease-specific quality of life [22] and treatment satisfaction [23]
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