Journal Article

Aflibercept treatment for patients with exudative age-related macular degeneration who were incomplete responders to multiple ranibizumab injections (TURF trial)

Croft, Daniel E, Wykoff, Charles C, Brown, David M, Maldonado, Maria E

2014

Overview

Aim To determine the efficacy of 2.0 mg aflibercept in the management of patients with recalcitrant exudative age-related macular degeneration (AMD). Methods In this prospective, open-label, single-arm clinical trial, patients were seen monthly and given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT). End point at month 6: mean change in Early Treatment Diabetic Retinopathy Study best corrected visual acuity (ETDRS BCVA) and central subfield thickness (CST), mean number of aflibercept injections, percentage of PRN injections required, patients with no fluid on SD-OCT and patients losing >15 letters. Results At baseline, 46 patients with a mean of 42 prior antivascular endothelial growth factor-A (anti-VEGF) intravitreal treatments had a mean of 74.2 letters (Snellen equivalent 20/32) and mean CST of 347 µm. ETDRS letters remained stable throughout the trial; at month 6, mean BCVA change was +0.2 letters (range −10 to +13, p=0.71). Anatomically, mean CST improved significantly from baseline at each study visit including −23.6 µm at month 1 and −27.3 µm at month 6 (p=0.018). Seventy-one of 90 (79%) possible PRN injections were required and a mean of 5.6 aflibercept injections out of the maximum six were administered. Ten of 45 (22%) patients had no retinal fluid on SD-OCT at month 6. No patient lost >15 letters. Conclusions Aflibercept 2.0 mg treatment maintained mean visual acuity improvements previously achieved with high-dose 2.0-mg ranibizumab injections in recalcitrant wet AMD patients. Aflibercept 2.0 mg treatment led to significant anatomic improvement and was required monthly in most patients. Clinical Trials Registration FDA IND#12462. NCT 01543568. Trial Details IND 12462, NCT 01543568 http://clinicaltrials.gov/show/NCT01543568.

• Publisher: BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Age / Aged / Aged, 80 and over / Angiogenesis Inhibitors - adverse effects / Angiogenesis Inhibitors - therapeutic use / Antibodies, Monoclonal, Humanized - therapeutic use / Clinical Science / Diabetic retinopathy / Drug dosages / Exudates and Transudates / Female / Humans / Intravitreal Injections / Iodine / Macular degeneration / Male / Middle Aged / Prospective Studies / Ranibizumab / Receptors, Vascular Endothelial Growth Factor - adverse effects / Receptors, Vascular Endothelial Growth Factor - therapeutic use / Recombinant Fusion Proteins - adverse effects / Recombinant Fusion Proteins - therapeutic use / Single-Blind Method / Subretinal Fluid / Tomography, Optical Coherence / Treatment Outcome / Vascular endothelial growth factor / Vascular Endothelial Growth Factor A - antagonists & inhibitors / Visual Acuity - drug effects / Wet Macular Degeneration - diagnosis / Wet Macular Degeneration - drug therapy / Wet Macular Degeneration - physiopathology