Abstract
BackgroundAnti–vascular endothelial growth factor (anti-VEGF) agents have become the standard of care in neovascular age-related macular degeneration (nAMD). Despite generally excellent response rates to anti-VEGF therapy, some patients do not respond or may respond suboptimally. In the case of refractory or rapidly recurring fluid in nAMD, clinicians may switch to another anti-VEGF agent. TITAN was an observational study that assessed the effectiveness and safety of intravitreal aflibercept (IVT-AFL) in patients with nAMD refractory to ranibizumab who switched to IVT-AFL after less than 12 months of ranibizumab treatment in routine clinical practice in France.MethodsTITAN was an observational, retrospective and prospective 12-month study conducted at 28 centres in France. Patients with nAMD refractory to ranibizumab were enrolled. Patients who were switched from ranibizumab to IVT-AFL were followed for 12 months. Data were obtained from medical records for retrospectively included patients, and at routine follow-up visits for those included prospectively. The main outcome measure was percentage of patients who achieved treatment success (gain of ≥1 Early Treatment Diabetic Retinopathy Study letters in best-corrected visual acuity [BCVA] and/or any reduction in central retinal thickness [CRT]) from baseline to 12 months after switching. A sample size of 225 patients was determined based on a 2-sided 95% confidence interval with a width equal to 0.12 when the sample proportion was 0.70.ResultsWe analysed safety data (N = 217) and clinical outcomes from patients in the per-protocol population (n = 125). The mean (standard deviation) number of IVT-AFL injections was 7.5 (2.6). Treatment success was achieved in 68.8% of patients. Mean BCVA change from baseline to Month 12 was + 1.5 letters (P = 0.105) and the mean CRT change was − 45.0 μm (P < 0.001). In a subgroup analysis, in patients who received three initial monthly IVT-AFL injections, mean BCVA gain was 3.3 letters at Month 12 (P = 0.015). Excluding lack of efficacy and inappropriate scheduling of drug administration, the most common adverse event was eye pain (2.3%).ConclusionsSwitching ranibizumab-refractory patients with nAMD to IVT-AFL may improve visual outcomes in some patients, particularly those who receive three initial monthly injections.Trial registrationClinicalTrials.gov, NCT02321241. First posted: December 22, 2014; Last update posted: July 2, 2018
Highlights
Anti–vascular endothelial growth factor agents have become the standard of care in neovascular age-related macular degeneration
In the case of refractory or rapidly recurring fluid in neovascular age-related macular degeneration (nAMD), clinicians may switch from the current antiVEGF agent to another anti-VEGF agent [12]
75% of patients had their first injection of ranibizumab < 0.3 months after diagnosis of nAMD
Summary
Anti–vascular endothelial growth factor (anti-VEGF) agents have become the standard of care in neovascular age-related macular degeneration (nAMD). In the case of refractory or rapidly recurring fluid in nAMD, clinicians may switch to another anti-VEGF agent. TITAN was an observational study that assessed the effectiveness and safety of intravitreal aflibercept (IVT-AFL) in patients with nAMD refractory to ranibizumab who switched to IVT-AFL after less than 12 months of ranibizumab treatment in routine clinical practice in France. Anti–vascular endothelial growth factor (anti-VEGF) agents, including intravitreal aflibercept (IVT-AFL) and ranibizumab, have become standard of care in nAMD [3,4,5,6,7,8]. In the case of refractory or rapidly recurring fluid in nAMD, clinicians may switch from the current antiVEGF agent to another anti-VEGF agent [12]. The VIEW 1 and VIEW 2 studies [13] assessed the efficacy and safety of IVT-AFL in patients with nAMD and demonstrated non-inferiority of IVT-AFL 2 mg, given every 8 weeks after three initial monthly doses, versus ranibizumab 0.5 mg, every 4 weeks, in maintaining vision (loss of < 15 Early Treatment Diabetic Retinopathy [ETDRS] letters in best-corrected visual acuity [BCVA]) in treatment-naïve patients over a 12-month period [14,15,16,17]
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