BackgroundWe set out a systemic review to evaluate whether off-label bevacizumab is as safe as licensed ranibizumab, and whether bevacizumab can be justifiably offered to patients as a treatment for age-related macular degeneration with robust evidence of no differential risk.Methods and FindingsMedline, Embase and the Cochrane Library were searched with no limitations of language and year of publication. We included RCTs with a minimum follow-up of one year which investigated bevacizumab or ranibizumab in direct comparison or against any other control group (indirect comparison). Direct comparison (3 trials, 1333 patients): The one year data show a significantly higher rate of ocular adverse effects (AE) with bevacizumab compared to ranibizumab (RR = 2.8; 95% CI 1.2–6.5). The proportion of patients with serious infections and gastrointestinal disorders was also higher with bevacizumab than with ranibizumab (RR = 1.3; 95% CI 1.0–1.7). Arterial thromboembolic events were equally distributed among the groups. Indirect comparison: Ranibizumab versus any control (5 trials, 4054 patients): The two year results of three landmark trials showed that while absolute rates of serious ocular AE were low (≤2.1%), relative harm was significantly raised (RR = 3.1; 95% CI 1.1–8.9). A significant increase in nonocular haemorrhage was also observed with ranibizumab (RR = 1.7; 95% CI 1.1–2.7). Bevacizumab versus any control (3 trials, 244 patients): We were unable to judge the safety profile of bevacizumab due to the poor quality of AE monitoring and reporting in the trials.ConclusionsEvidence from head-to-head trials raises concern about an increased risk of ocular and multiple systemic AE with bevacizumab. Therefore, clinicians and patients should continue to carefully weight up the benefits and harms when choosing between the two treatment options. We also emphasize the need for studies that are powered not just for efficacy, but for defined safety outcomes based on the signals detected in this systematic review.

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ObjectivesThe aim of this study was to assess patients’ views and expectations with regard to neovascular age-related macular degeneration (nAMD) and intravitreal anti-VEGF therapy (IVT).MethodsWe conducted a multicenter, non-interventional, prospective cohort study including nAMD patients treated with IVT in Germany. Patients with at least one IVT before study enrollment and aged ≥50 years were included. Three telephone interviews were conducted during a 12-month observational period. Here, patient’s beliefs/expectations with regard to the nAMD disease and the IVT treatment were discussed. Only patients who completed all three phone interviews were included in the analyses. We used a two-step cluster analysis to identify patient clusters regarding specific patient attitudes towards nAMD and its treatment.ResultsThree hundred and thirty-two patients completed all interviews (mean age of 76.4 ± 7.2 years, 59.0% women). Out of these, 57.8% acknowledged that they needed general assistance in daily life, while 77.4% stated being able to attend general medical appointments on their own. However, 64.7% needed a driver or an accompanying person to attend their IVT appointments.In addition, 3.9% of the patients were afraid of IVT side effects. Also, 87.3% and 43.1% of the patients could name their disease or the anti-VEGF drug administered, respectively. More than three-quarters of the patients (83.1%) were aware of possible consequences of nAMD by stating vision loss or blindness, but only 16.6% knew that nAMD is a chronic disease.Generally, patients were optimistic: 70.2%, 5.1% and 13.0% of them expected stable visual acuity (VA), a significant improvement or expected worsening of VA in the next year, respectively. Almost two thirds of patients who provided their therapy expectations (47.0%) anticipated fewer injections/discontinuation of IVT.We identified five patient clusters differing significantly from each other with regard to four variables: being afraid of IVT, nAMD disease awareness, optimism with regard to effectiveness of IVT, and nAMD disease and treatment knowledge.ConclusionsOnly a minority of patients is aware of the chronic nature of nAMD. To motivate patients to accept a life-long IVT treatment, physicians and caregivers must know that there exist different patient types with significant differences in communication needs.