Incidence of New Choroidal Neovascularization in Fellow Eyes of Patients With Age-Related Macular Degeneration Treated With Intravitreal Aflibercept or Ranibizumab

Abstract

to neovascular age-related macular degeneration (nAMD) in untreated fellow eyes of patients who are treated for nAMD in 1 eye with anti-vascular endothelial growth factor agents provides important prognostic information to clinically manage patients. OBJECTIVE To investigate the association of treatment assignment (intravitreal aflibercept vs ranibizumab) and baseline characteristics with fellow eye conversion to nAMD in the VEGF (Vascular Endothelial Growth Factor) Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) studies. DESIGN, SETTING, AND PARTICIPANTS This post hoc analysis of the VIEW 1 and VIEW 2 studies (randomized, double-masked, active-controlled, multicenter, 96-week, phase 3 trials comparing the efficacy and safety of intravitreal aflibercept in 2457 patients with treatment-naive eyes with nAMD) analyzed a subgroup of participants treated for nAMD in 1 eye who had untreated fellow eyes without neovascularization at baseline. All participants in the VIEW studies were included in 1 of 4 groups: ranibizumab, 0.5 mg, every 4 weeks; aflibercept, 2 mg, every 4 weeks; aflibercept, 0.5 mg, every 4 weeks; or aflibercept, 2 mg, every 8 weeks after 3 injections at 4-week intervals. Data collection in the VIEW studies occurred from July 2007 to August 2011; the data analysis presented in this report took place from April 2016 to November 2018. INTERVENTIONS Patients received no treatment in the fellow eyes unless after conversion to nAMD, when any treatment approved by heath authorities was given per the investigators' discretion. MAIN OUTCOMES AND MEASURES Incidence of conversion to nAMD in patients with untreated fellow eyes that had not had clinical signs of neovascularization at baseline. RESULTS A total of 1561 participants were included in this analysis. At 96 weeks, 375 patients (24.0%) experienced cases of conversion to neovascular disease in the fellow eye, including 107 of the 399 individuals who received ranibizumab, 0.5 mg, every 4 weeks; 93 of the 387 individuals who received aflibercept, 2 mg, every 4 weeks; 84 of the 387 individuals who received aflibercept, 0.5 mg, every 4 weeks; and 91 of the 388 individuals who received aflibercept, 2 mg, every 8 weeks after 3 doses at 4-week intervals. The rates were 18.1, 16.2, 14.7, and 16.0 per 100 patient-years at risk at week 96, respectively. On multivariate analysis, fellow eye conversion was associated with increasing patient age (per 10 years) at baseline (hazard ratio [HR], 1.20 [95% CI, 1.05-1.36]), female sex (HR, 1.32 [95% CI, 1.06-1.63]), intraretinal fluid in the study eye at baseline (HR, 1.28 [95% CI, 1.02-1.61]), and increasing choroidal neovascularization lesion size (per 10 mm 2) in the study eye at baseline (HR, 1.29 [95% CI, 1.06-1.57]). Rates of fellow eye conversion were similar with either of the treatments. CONCLUSIONS AND RELEVANCE In this secondary analysis of randomized clinical trial data, patients with active nAMD in 1 eye appeared to have a high risk for fellow eye conversion. Such patients should be monitored clo...

Fellow-Eye Conversion and Treatment in Exudative Age-Related Macular Degeneration

“…[11][12][13][14][15][16][17] Conversion in the fellow eye has been reported to occur in between 6% and 30% of patients having unilateral wet AMD for 5 years. [24][25][26] Our results reflect similar findings, with conversion rates ranging from 3.3% to 5.7% during the first 2 years of follow-up and treatment in 1 eye, to between 20.3% and 36.4% from 2 years onward ( Figure 2). Few studies have compared the frequency of intravitreal injections between initially diagnosed and fellow eyes.…”

“…24 This has been supported by more recent studies as well, showing a rate of conversion approximating 30% over the course of 5 years. 25,26 Furthermore, it has been suggested that the type of CNV presenting in the first eye could be predictive of the neovascularization patterns manifesting in the fellow eye, and response to treatment in one eye may potentially be used to predict responses to anti-VEGF therapy in the fellow eye. 27 To date, there is minimal evidence regarding the suggested frequency of screening of wet AMD in the fellow eye after unilateral diagnosis of wet AMD.…”

Influence of unilateral intravitreal bevacizumab injection on the incidence of symptomatic choroidal neovascularization in the fellow eye in patients with neovascular age‑related macular degeneration (Review)

“…Another key problem is the influence of anti-VEGF treatment in one eye on the fellow eye that has no clinical signs of neovascularization at baseline. Post hoc analysis of some major randomized, double-masked, active-controlled, multicenter clinical trials could not reveal any consistent influence of intravitreal ranibizumab or aflibercept injections on fellow eye conversion rates (17,18). When studying bevacizumab, also, no difference was noted in the first study year (7.2% of patients treated with bevacizumab vs. 7.9% of patients treated with ranibizumab).…”

“…Literature data largely vary on this topic. In clinical trials fellow eye involvement was noted at 22, 24 and 36.3% of patients by 24 months (16)(17)(18), regardless of the medication. A recent real-life evaluation reported a 32% fellow eye involvement rate at two years (19).…”

“…A recent real-life evaluation reported a 32% fellow eye involvement rate at two years ( 19 ). Severe macular changes in the affected eye (larger membranes, more intraretinal fluid) in addition to increased age, female sex and genetic disposition correlate to a higher risk of second eye involvement ( 18 , 20 ). Optical coherence tomography angiography (OCTA) evaluation suggests that the presence of subclinical CNV in fellow-eye is associated with an increased risk of exudation ( 21 , 22 ).…”