First Author: M.Silva PORTUGAL
Co Author(s): M. Falcao S. Penas F. Pedro V. Fernandes V. Rosas F. Falcao Reis
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Diabetic macular edema (DME) is caused by breakdown of the blood-retinal barrier and leaking microaneurysms. Because vascular endothelial growth factor (VEGF) is the primary factor for retinal vascular hyperpermeability, anti-VEGF agents are used as first line therapy for DME, improving edema and vision in some patients. In contrast, anti-VEGF resistant DME, suggests chronic inflammation. Recently, many clinical studies have found that some eyes with DME have poor visual outcomes despite successful treatment and complete resolution of edema. The purpose of this analysis is to report the efficacy outcomes after treatment with 0.2 μg/day FAc implant in real-life practice.
São João Hospital, Oporto - Portugal
Twelve patients (12 eyes) with chronic DME who had undergone FAc single implant insertion were assessed. All patients had previously been treated with anti-vascular endothelial growth factor agents and/or short-acting steroids. The mean follow-up was 7.3±1.2 months (mean± standard error). Mean functional and anatomical responses were assessed by best corrected visual acuity (BCVA) in early treatment diabetic retinopathy study (ETDRS) letters and optical coherence tomography (OCT) examinations, respectively. Safety outcome measures included mean change in intraocular pressure (IOP).
All eyes had previously been injected with intravitreal anti-VEGF (mean, 5.3±1.3; range, 0 to 14) and/or steroid (mean, 4.7±0.5; range, 2 to 7). The mean duration of DME was 5±0.4 years. The mean BCVA went from 54.3±3.9 to 56.4±3.9 ETDRS letters (p=0.466) and mean central macular thickness (CMT) decreased from 533.3±73.5 to 332.6±31.1 µm (p=0.025). The mean IOP increase at last observation was -0.1± 0.90 versus 14.2±1.1 (p=0.905).
Data from real-life clinical practice shows that the FAc implant contribute to improvements in BCVA and statistically significant improvements in CMT in chronic DME patients insufficiently responsive to current treatment options. These results are in line with the latest observations that imply that visual acuity is likely multi-factorial and maybe related to damage or disruption of the retinal architecture or direct photoreceptor damage. In this analysis patients received an elevated number of previous anti-VEGF and/or short-acting corticosteroids and presented a long duration of DME, which may have compromised the integrity of the retinal and the visual outcomes. This hypothesis still should be proven but many papers have addressed the use of imagining techniques for the identification of reliable markers of current and future visual acuity in patients with DME. The real-life clinical practice of the FAc intravitreal implant has shown efficacy equivalent to that seen in a few cases reports in the public domain. This results have also shown that the number of patients experiencing an elevation in IOP may be fewer than reported in the FAME studies. This suggests that FAc intravitreal implant may be considered early in the DME treatment pathway. Further follow-up and monitoring is ongoing.