Session Title: New Drug Treatment and Technology II
Session Date/Time: Sunday 20/09/2015 | 09:00-10:30
Paper Time: 09:48
First Author: : R.Muhammed Bafiq UNITED KINGDOM
Co Author(s): : B. Patel S. Shafquat
PURPOSE:To demonstrate the non-inferiority outcome of intravitreal Aflibercept vs intravitreal Ranibizumab and to evaluate the changes in macular morphology and visual acuity in eyes switched to intravitreal Aflibercept injections for neovascular age related macular degeneration (nARMD)
Macula Clinic, Department of Ophthalmology, Russells Hall Hospital, Dudley, UK
A single centre, prospective, observational study was carried out on eyes with nARMD which were refractory to repeated treatment with intravitreal Ranibizumab injections. Treatment switch to intravitreal aflibercept was indicated when recurrent or persistent disease activity was demonstrated by the presence of any active choroidal neovascular membrane (CNV), haemorrhage, intra-retinal fluid (IRF), sub-retinal fluid (SRF) and pigment epithelial detachment (PED). The changes in macular morphology were evaluated by serial spectral domain Optical Coherence Tomography (OCT). Best Corrected Visual Acuity (BCVA) was assessed using ETDRS letters. Observations were made at the time of decision to switch from Ranibizumab to Aflibercept (baseline visit) and at the six week follow up visit after three Aflibercept injections given at monthly intervals (Loading dose). Relevant data was collected from clinical notes, Fundus Fluorescein Angiography (FFA) and OCT imaging using Snap survey software and analyzed by Excel descriptive statistics tool.
Forty two eyes of thirty eight patients were included in the study. The mean BCVA was 48 ETDRS letters (range 27 -72) after an average number of 21 Ranibizumab injections (range 12-43) at baseline. At follow up clinic visit (after 3 Aflibercept injections), there was no change in mean BCVA. Fourteen eyes (33%) had gained 1-5 letters and three (7%) had gained more than 6 letters. Seventeen eyes (40%) lost at least one letter and out of these, three eyes (7%) lost more than 15 letters. Mean Central foveal thickness (CFT) decreased by 62 microns (µ). Presence of PED, IRF and SRF had improved from baseline to follow up visit, from 72% down to 60%, 74% down to 29% and 24% down to 12%, respectively. Presence of hyper reflective dots and stalactites seen on OCT also showed improvement from baseline. However, number of eyes having sub-retinal fibrosis at baseline increased from 24 (57%) to 26 (62%) at follow up visit.
There was no significant change in visual acuity (more than15 letter loss or gain) after switching to Aflibercept from Ranibizumab which may reflect the non-inferiority of intravitreal Aflibercept injection. Improvement in macular morphology was noted in the form of reduction in central foveal thickness, pigment epithelial detachment, sub-retinal fluid, intra-retinal fluid, hyper reflective dots and stalactites after three doses of intravitreal Aflibercept injections. Relative increase in fibrosis following Aflibercept injections were noted which may cause some concern in the course of long term treatment. Follow up over a longer period is recommended in the future to address this issue. We plan to repeat the study at one year following switching from intravitreal Ranibizumab to intravitreal Aflibercept injections.