First Author: V.Castro Navarro SPAIN
Co Author(s): E. Cervera Taulet J. Montero Hernández L. Hernández Bel C. Torralba Rull C. Navarro Palop N. Doménech Aracil 0 0 0 0 0 0 0 0 0
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Intravitreal antivascular endothelial growth factor (anti-VEGF) agents, ranibizumab (Lucentis ®), a drug approved for use, or bevacizumab (Avastin ®), off label use medication, have significantly improved visual outcomes in patients with wet age- related macular degeneration (AMD). Aflibercept, another new therapy, an inhibitor of multiple growth factors, bimonthly has shown in pivotal studies VIEW 1 and 2, non-inferiority to monthly ranibizumab administration. Our objective is to evaluate the anatomic and visual effect of intravitreal aflibercept in cases of recalcitrant wet-AMD after a single injection and after one year of treatment according to a pro re nata (PRN) schedule.
A retrospective observational case series in Hospital General de Valencia was conducted to identify patients with subfoveal choroidal neovascularization (CNV) in 1 or both eyes resistant to treatment with ranibizumab or bevacizumab who were switched to treatment with aflibercept according to PRN schedule during one year of follow-up
Retrospective observational study with patients diagnosed of wet-AMD with subfoveal CNV resistant to prior treatment with ranibizumab and/or bevacizumab who were switched to aflibercept PRN treatment. A written consent was obtained from the patients prior to each injection. The inclusion criteria included patients with wet-AMD showing insufficient or diminishing treatment effects under ranibizumab / bevacizumab therapy or no anatomical or functional improvement after the loading dose of three monthly ranibizumab/bevacizumab injections. Signs of active CNV were considered the persistence/recurrence of retinal fluid, new retinal hemorrhages and leakage from the CNV observed by fluorescein angiography. Each patient underwent distance best-corrected visual acuity (BCVA) measurements using an Early Treatment Diabetic Retinopathy Study chart at 4 metres, and qualitative/quantitative analysis of images was obtained by spectral-domain OCT scanning (OCT 3-D; Topcon Corporation). A Wilcoxon test for paired nonparametric variables was used. Statistical significance was defined as P values < 0,05.
Thirty eyes of 28 patients (10 males and 18 females) with a mean age of 78 ± 8 years were included. From the 30 eyes, 21 were the right eye (RE) and 9 were the left eye (LE). Patients had received previously a mean of 6 ± 3(range 3-15) intravitreal anti- VEGF injections at the study eye. During a mean follow-up of 267,90 ± 64,31 days, patients received a 3,83± 1,51 ( range 1-7) aflibercept injections. A statistically significant decrease (p=0.002683) in CMT(μ) after one single aflibercept injection was found; reducing from 305,5± 68,533µ to 257,07± 46,96µ. At the end of the study the average CMT was of 275,33± 33,67; 30 µ less (p=0.1623) than prior to aflibercept. The mean logMAR BCVA at baseline decreased from 0,59 to 0,60( p>0,05) after the first injection and improved to 0.5633 after twelve months( p> 0,05). After one single injection an anatomic response was observed in 83,3% of patients with complete resolution of the retinal fluid in 73,3% of them. After one year of follow –up 70% of patients presented an anatomic improvement with presence of subretinal/intrarretinal in 43% of the study eyes.
The purpose of this retrospective observational case series was to study the outcome and long-term effect at one year of follow-up after a switch to aflibercept treatment in eyes with exudative AMD that developed resistance to repeated treatments with either ranibizumab or bevacizumab. Taken together, our data showed a significant decrease in CMT suggesting that aflibercept therapy improved retinal thickness in previously unresponsive eyes. Although no stadistically significant changes in BCVA were found, at the end of the study patients presented an improvement in visual acuity increasing from 0,59 logMAR to 0,56 logMAR. There was a complete anatomic response after one single injection, with persistence of retinal fluid in 26,6 % of patients. After an average of 3,83 aflibercept injections only 13 of the 30 eyes presented intraretinal and/or subretinal fluid on OCT . Among these patients, the OCT appearance was unchanged or improved in 11 of them, when compared to baseline. We describe a new therapy for the treatment of wet-AMD that in preliminary studies, including ours, has shown its effectiveness with a single injection; while maintaining a reduction in foveal thickness and an anatomical improvement in a majority of patients after a year of treatment.