First Author: P.Reis PORTUGAL
Co Author(s): S. Pedro M. Cordeiro G. Pires D. Portela J. Carvalho L. Queiroz
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DME is the most common cause of acquired blindness in working-age adults. In the last years, treatment for DME faced a paradigm shift, from laser to intravitreal anti-vascular endothelial growth factor (anti-VEGF) and steroids. First-line therapy is anti-VEGF, however, some patients do not benefit from those treatments. Additionally, there is a significant burden from injections and office visits imposed by the anti-VEGF treatment regimens. After an inadequate response to three monthly anti-VEGF injections, the tendency is to move to steroids therapy. We aim to evaluate safety and efficacy of FAc in patients with chronic DME.
This study was carried out in the five public hospitals of the south of Portugal, between July 2015 and February 2017. Collection of demographic data, their medical and treatment history as well practice regarding diabetic eye care was carried out.
Retrospective data was collected from all chronic DME patients that were injected with FAc intravitreal implant. Efficacy parameters as visual acuity (VA), central retinal thickness (CRT) and macular volume (MV) were collected at baseline, month 1, 3 and 6. A safety parameter, intraocular pressure (IOP) was measured at the same time as efficacy parameters.
Our study included 20 patients, 10 males and 10 females, with a mean age of 64.2 years and a mean duration of DME of approximately 2.6 years. 95% of patients (n=19) had previous laser therapy, while 100% of the eyes performed previous anti-VEGF therapy (bevacizumab, ranibizumab or aflibercept). Only 35% (n=7) of patients were treated previously with steroids. At baseline VA, CRT, MV and IOP was: 52.9 ± 4.92 letters ETDRS (mean ± standard error), 556.1 ± 41.20 μm, 11.71 ± 0.81 mm3 and 15.67 ± 0.65 mmHg, respectively. Mean VA at month 1, month 3 and month 6 was 57.7 ± 4.68; 57.5 ± 5.72 and 67.6 ± 5.72 letters ETDRS, respectively. Mean CRT month 1, month 3 and month 6 was 397.3 ± 43.87; 378.0 ± 58.99 and 312.2 ± 31.58 μm, respectively. It was observed a mean MV decreased from baseline to 10.39 ± 0.76; 9.67 ± 0.33 and 9.62 ± 0.67 mm3 at month 1, 3 and 6 respectively. The safety parameter, mean IOP increased from baseline to month 1, 3 and 6 to 16.95 ± 0.94; 16.38 ± 0.88 and 16.57 ±1.17 mmHg. No adverse events related with the injection procedure were observed.
Our study showed a sustained gain in VA from baseline with FAc treatment in this chronic and previously treated population. CRT, as well as MV demonstrated a decrease after FAc therapy. FAc was safe in what concerns IOP: no significant increase of values was observed. Diabetic retinopathy is an incurable chronic eye disease, requiring long life management and thus, patients would benefit from a long-term treatment. FAc is an implant that allows a continuous release of the drug inside the eye which as proven its efficacy and safety. Its use can help free chronic patients from the burden of injections and office visits.