First Author: A.Hamoud UK
Co Author(s): S. Younis C. Quijano E. Yang M. Habeb S. Pasu A. AlHassany F. Rahman
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Wet age-related macular degeneration (wARMD) is the leading cause of central visual loss in elderly patients in the developed countries. Overexpression of vascular endothelial grown factor (VEGF) is known to play a major role in the pathogenesis of choroidal neovascularization. Aflibercept is a fully human, recombinant fusion protein that inhibits VEGF. Most of the previous studies focused on bevacizumab and ranibizumab for treating wARMD. As Aflibercept was approved more recently, its effect when used in Treat-and-Extend fashion is still unclear. Our study assess the long term effectiveness and safety of Aflibercept intravitreal injections in a Treat-and-Extend regimen for wARMD.
Macula clinic - Western Eye Hospital Imperial Healthcare NHS trust, London UK.
We performed a retrospective observational review of clinical notes of 185 consecutive patients (206 eyes) diagnosed with wARMD and treated between October 2013 and early March 2017 at the Western Eye Hospital. They were all treatment-naïve and the eyes had macular fluid on OCT with active leakage confirmed by fundus fluorescein angiography (FFA) at baseline. Treatment with 0.05ml/2mg intravitreal Alibercept was given at monthly intervals for three months, then an injection of Aflibercept was given on a two monthly basis during the first year. In the second and third year, if the macula was stable, then an injection was given every 12 weeks. If the disease was active we kept injecting the eye bi-monthly. The disease was considered to be active if there was sign of macular haemorrhage, macular pigment epithelial detachment (PED) with subretinal fluid/intrretinal fluid or if there is loss of 5 letters or more in the best corrected visual acuity (BCVA). We collected data on demographics. Best corrected visual acuity (BCVA) and optical coherence tomography (OCT) at baseline and BCVA and OCT in every visit. All patients underwent fundus fluorescein angiography (FFA) on their first visit. Complications and secondary effects from the injections were also recorded.
185 clinical notes were reviewed. The mean age at baseline was 80 years (50-95). 40% of patients were males, 60% were females. The mean duration of their treatment was 11.7 months (3-30 range). 88 patients reached the 24 months and 24 patients 36 month treatment. The mean BCVA changed from 0.63 LogMAR to 0.46 (P<0.00000004) after the first 12 months, to 0.42 LogMAR (P<0.0001) after 24 months and to 0.37 LogMAR (P<0.05) after 36 months. After the 1st year of treatment 79% of the patients improve vision compared to 11% that remained the same and 13% that got worse. 65% of patients gained 15 letters or more after 12 month treatment. 34% and 17% of patients gained 15 or more letters after 24 and 36 months of treatment respectively. The OCT Central Retinal Thickness (CRT) measurement changed from 316 μm to 255 μm (P<0.000004) after the first 12months, to 253 μm after 24 months (P<0.000000015) and to 242 μm after 36 months (P<0.023) The mean number of injections during the first year was 6 ±0.9. 4 ±1.5, 3.6 ±1.2 during 2nd third years. No complications or secondary effects of the treatment were reported.
Aflibercept showed to be effective and safe for improving and maintaining the BCVA and CRT for wARMD for up to 36 months in a Treat and Extend regime. After 12 months following the Treat-and-Extend Aflibercept protocol regimen 90% of patients either maintained or get their vision improved and 88% after 36 months. Using a treat-and-extend regimen is effective for improving BCVA and CRT in eyes with wARMD in the long term