A single-arm, investigator-initiated study of the efficacy, safety and tolerability of intravitreal aflibercept injection in subjects with exudative age-related macular degeneration, previously treated with ranibizumab or bevacizumab: 6-month interim analysis

• Published in: British journal of ophthalmology Vol. 98; no. Suppl 1; pp. i22 - i27
• Main Authors: Singh, Rishi P, Srivastava, Sunil, Ehlers, Justis P, Bedi, Rumneek, Schachat, Andrew P, Kaiser, Peter K
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.06.2014; BMJ Publishing Group
• Subjects: Aged; Aged, 80 and over; Angiogenesis Inhibitors - administration & dosage; Antibodies, Monoclonal, Humanized - administration & dosage; Bevacizumab; Diabetic retinopathy; Drug dosages; Drug Therapy, Combination; Failure; Female; Fluorescein Angiography; Follow-Up Studies; Fundus Oculi; Health Insurance Portability & Accountability Act 1996-US; Humans; Intravitreal Injections; Macular degeneration; Male; Molecular weight; Original; Patients; Prospective Studies; Ranibizumab; Receptors, Vascular Endothelial Growth Factor - administration & dosage; Recombinant Fusion Proteins - administration & dosage; Single-Blind Method; Studies; Time Factors; Tomography, Optical Coherence; Treatment Outcome; Vascular endothelial growth factor; Visual Acuity; Wet Macular Degeneration - drug therapy; Wet Macular Degeneration - pathology; Neovascularisation; Angiogenesis; Macula; Retina; Clinical Trial
• ISSN: 0007-1161; 1468-2079
• DOI: 10.1136/bjophthalmol-2013-304798

Aim To evaluate efficacy and safety of intravitreal aflibercept injection (IAI) in subjects who were previously treated with ranibizumab and/or bevacizumab for active exudative age-related macular degeneration (AMD). Methods Patients (n=26) were enrolled in a 12-month prospective, interventional, single arm, investigator-initiated study with planned 6-month interim analysis. Patients with active exudative AMD, previously treated with ranibizumab and/or bevacizumab, were treated with 2 mg IAI every month for the first 3 months, followed by a fixed dosing schedule of 2 mg IAI every 2 months. The primary study endpoint was the mean absolute change from baseline central subfield thickness (CST) at month 12 as measured by SDOCT. Secondary outcomes included mean change from baseline best-corrected visual acuity (BCVA) score, percentage of subjects who gained or lost greater than or equal to 15 letters of vision, percentage of subjects who are 20/40 or better, percentage of subjects who are 20/200 or worse, and the incidence of adverse events (AE) and serious AEs. Results Planned 6-month interim analysis demonstrated a mean decrease in CST of 38.6 µm (p<0.001) and a mean increase in ETDRS BCVA of +5.9 letters (p<0.001). Fifteen percent of subjects experienced a greater than 15-letter improvement in visual acuity, 84.6% of patients gained visual acuity, and no patient lost 3 lines of vision from baseline. Forty-two percent of subjects were 20/40 or better, and 11.5% of subjects were 20/200 or worse at month 6. No serious ocular or systemic AEs were encountered. Conclusions IAI-treated eyes demonstrated improved short-term functional and anatomic endpoints in subjects with active exudative AMD switching from previous anti-VEGF treatment when given in a fixed dosing scheme for 6 months. Trial registration number NCT01617148.