Efficacy and safety of intravitreal aflibercept in ranibizumab-refractory patients with neovascular age-related macular degeneration

• Published in: BMC ophthalmology 2021-02, Vol.21 (1), p.90-90, Article 90
• Main Authors: Razavi, Sam, Kodjikian, Laurent, Giocanti-Aurégan, Audrey, Dufour, Ingrid, Souied, Eric
• Format: Article
• Language: English
• Subjects: Acuity; Adverse events; Age; Age-related macular degeneration; Angiogenesis Inhibitors - therapeutic use; Diabetes; Diabetes mellitus; Diabetic retinopathy; Exudative; France; Humans; Immunotherapy; Intravitreal Injections; Macular degeneration; Macular Degeneration - drug therapy; Medical records; Monoclonal antibodies; Observational; Ophthalmology; Patients; Performance evaluation; Prospective Studies; Ranibizumab - therapeutic use; Receptors, Vascular Endothelial Growth Factor - therapeutic use; Recombinant Fusion Proteins - therapeutic use; Retina; Retinopathy; Retrospective Studies; Safety; Success; Switch; Treatment Outcome; Vascular endothelial growth factor; Visual Acuity
• ISSN: 1471-2415; 1471-2415
• DOI: 10.1186/s12886-021-01841-6

Anti-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. TITAN 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. We 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