First Author: F.Manco Lavado SPAIN
Co Author(s): L. Lima Modino C. Blando Labrandero S. Crespo Millas M. Ramoa Osorio M. Lopez Galvez
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The purpose of this study was to assess the changes in optical coherence tomography (OCT) and visual effect at 6 months of intravitreal aflibercept 2.0 mg in patients with refractory and long-term evolution of exudative age-related macular degeneration (AMD) treated with ranibizumab 0.5 mg. The null hypothesis was the lack of anatomical and functional improvements in study eyes after switching from ranibizumab to aflibercept at 6 months of treatment.
Retrospective and interventional study conducted at the Department of Ophthalmology at the University Clinic Hospital of Valladolid, Spain of patients with refractory exudative AMD treated with a pro re nata (PRN) regimen with intravitreal aflibercept. These patients were previously long-term treated with intravitreal ranibizumab obtaining an incomplete therapeutic response.
All patients underwent a complete ophthalmic examination every month, including best-corrected visual acuity (BCVA), intraocular pressure (IOP), slit lamp examination and spectral domain OCT (Topcon OCT 3D Model 1000) evaluation. Patients were followed-up for at least 6 months. Inclusion criteria were males and females, an age of 60 years or older, active choroidal neovascularization (CNV) lesions due to AMD that affect the central subfield in the study eye that was treated with ranibizumab for at least 12 months, and presence of OCT signs of incomplete therapeutic response. The incomplete therapeutic response was defined as the presence in OCT analysis of macular edema, intraand/or subretinal fluid and/or a 10% increase in pigment epithelial detachment (PED) height affecting the central subfield of the study eye. Main exclusion criteria were retinal pigment epithelium (RPE) rip/tear in the study eye, and any evidence of a concurrent intraocular condition that limits the potential to gain visual acuity upon switching to aflibercept therapy. Main outcome measures were mean average change in BCVA (LogMAR: logarithm of minimum angle of resolution), central subfield macular thickness (CSMT), intraand/or subretinal fluid and PED height from baseline to month 6. Two single masked investigators performed all OCT measurements.
A total of 51 eyes of 51 patients with exudative AMD were switched to aflibercept. At the beginning of aflibercept therapy, the mean age of patients was 77.75±8.8 years-old and 51% were male. The switch to aflibercept was performed after a mean numbers of intravitreal ranibizumab injections of 11.16±6.8 and a mean duration of active CNV lesions of 40.08±25.9 months At the onset of aflibercept therapy, type 1 CNV (under the RPE) was found in 51.1% of cases and type 2 CNV (under the neurosensory retina) in 48.9%. Spectral domain OCT evaluation showed that the mean baseline CSMT was 298.72±91.8 microns, 92% of cases had subretinal fluid, 78% PEDs, and 60% intraretinal fluid. The mean baseline BCVA was 0.46±0.2 LogMAR. At 6 months, the CSMT improved to 276.64±90.6 microns (p<0.05) after an average of 3.15 aflibercept injections (range 1–6). In addition, a decrease of intraand subretinal fluid and PEDs of 43.3%, 26.1% and 25.6% respectively were evidenced. However, 13.7% of cases developed macular atrophy and 21.5% subretinal fibrosis. The BCVA did not improve at 6 months (0.48±0.3 LogMAR, p=0.6). Intravitreal aflibercept therapy was well tolerated with no adverse events reported.
Switching from ranibizumab 0.5 mg to aflibercept 2.0 mg produced significant improvements in central macular thickness and OCT measurements, but not in the visual acuity, in patients with long-term ranibizumab treatment for exudative AMD in clinical practice. Long-term AMD and delay of treatment change can avoid visual recovery. Post-treatment adverse events were uncommon.