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[This corrects the article DOI: 10.1371/journal.pone.0246626.].
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BACKGROUND: Diabetic macular oedema (DMO) is the leading cause of sight impairment in working age populations in developed countries. Current first line treatment for centre-involving DMO involves intravitreal anti-VEGF but treatment response can be variable. In this retrospective, real world, multi-centre cohort study, we aim to identify ocular and systemic characteristics that correlate with anatomical and functional outcomes for treatment-naive DMO patients treated with intravitreal aflibercept. METHODS: Retrospective multicentre cohort study of treatment-naive DMO patients initiated on aflibercept at three North West London hospitals between 2016 and 2018. Baseline systemic and ocular factors, best corrected visual acuity (BCVA) and central macular thickness (CMT) at 12 months were determined and statistically analysed. RESULTS: A total of 270 eyes of 221 DMO patients met inclusion criteria. Mean age was 62.8 ± 12.1, mean baseline HbA1c was 67 ± 20 mmol/mol, and mean eGFR was 72 mL/min/1.7m2. Mean number of aflibercept injections at 12 months was 6.2. Better baseline BCVA, lower baseline CMT, and absence of epiretinal membrane (ERM) were associated with better BCVA at 12 months whilst lower baseline CMT and proliferative retinopathy status were associated with lower CMT at 12 months. CONCLUSION: Our study is the largest real-world dataset examining factors influencing functional and anatomical response to aflibercept in DMO in the UK. Older age, lower baseline BCVA, higher baseline CMT and more severe diabetic retinopathy were associated with poorer visual acuity at 12 months and prioritisation of these patients within a pressured healthcare setting is recommended.
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PURPOSE: To evaluate the clinical outcomes of patients with treatment-naïve diabetic macula oedema (DMO) treated with Aflibercept in routine clinic settings in ethnically diverse North West London (NWL) and compare to outcomes reported in the VIVID and VISTA clinical trials. METHODS: This was a retrospective multicentre interventional case series. Two hundred and seventy eyes of 221 treatment-naïve patients at three NWL hospitals initiated on Aflibercept and who had at least 12 months follow-up were included in the study. Visual acuity, central subfield thickness and macula volume were recorded at baseline, month 3, 6 and 12. RESULTS: There were significant differences between the NWL cohort and participants in the VIVID and VISTA trials at baseline including higher HbA1c and a higher proportion of eyes with proliferative diabetic retinopathy in the NWL cohort. The mean VA, mean CSFT and mean MV at baseline was 66.4 (± 14.6) letters, 417 (± 94) µm and 10.3 (± 1.9) mm3. The mean VA gain at 12 months was 4.0 (± 11.8) letters (p < 0.001); a total of 26% of eyes gained ≥ 10 letters, 15% of eyes gained ≥ 15 letters and 6% lost ≥15 letters. At 12-months, the mean reduction in CSFT was 108 (± 96) µm (p<0.001) and the mean reduction in MV was 1.05 (± 1.21) mm3 (p<0.001). An average of 6.2 (± 2.3) injections was given over 12 months. There was a significant association between functional and anatomical response category at 3 months and response category at 12 months (p<0.001). CONCLUSION: The effectiveness of treatment with Aflibercept for patients in NWL was meaningfully lower than was reported in the VIVID and VISTA clinical trials. A high proportion of patients with good visual acuity at baseline, poorer glycaemic control, worse diabetic retinopathy and under-treatment likely contributed to lower functional and anatomical outcomes.
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Inhibidores de la Angiogénesis/administración & dosificación , Retinopatía Diabética/tratamiento farmacológico , Edema Macular/tratamiento farmacológico , Receptores de Factores de Crecimiento Endotelial Vascular/administración & dosificación , Proteínas Recombinantes de Fusión/administración & dosificación , Anciano , Inhibidores de la Angiogénesis/farmacología , Ensayos Clínicos como Asunto , Retinopatía Diabética/fisiopatología , Humanos , Londres/etnología , Edema Macular/fisiopatología , Persona de Mediana Edad , Proteínas Recombinantes de Fusión/farmacología , Estudios Retrospectivos , Resultado del Tratamiento , Agudeza Visual/efectos de los fármacosRESUMEN
The management of diabetic retinopathy (DR) has evolved considerably over the past decade, with the availability of new technologies (diagnostic and therapeutic). As such, the existing Royal College of Ophthalmologists DR Guidelines (2013) are outdated, and to the best of our knowledge are not under revision at present. Furthermore, there are no other UK guidelines covering all available treatments, and there seems to be significant variation around the UK in the management of diabetic macular oedema (DMO). This manuscript provides a summary of reviews the pathogenesis of DR and DMO, including role of vascular endothelial growth factor (VEGF) and non-VEGF cytokines, clinical grading/classification of DMO vis a vis current terminology (of centre-involving [CI-DMO], or non-centre involving [nCI-DMO], systemic risks and their management). The excellent UK DR Screening (DRS) service has continued to evolve and remains world-leading. However, challenges remain, as there are significant variations in equipment used, and reproducible standards of DMO screening nationally. The interphase between DRS and the hospital eye service can only be strengthened with further improvements. The role of modern technology including optical coherence tomography (OCT) and wide-field imaging, and working practices including virtual clinics and their potential in increasing clinic capacity and improving patient experiences and outcomes are discussed. Similarly, potential roles of home monitoring in diabetic eyes in the future are explored. The role of pharmacological (intravitreal injections [IVT] of anti-VEGFs and steroids) and laser therapies are summarised. Generally, IVT anti-VEGF are offered as first line pharmacologic therapy. As requirements of diabetic patients in particular patient groups may vary, including pregnant women, children, and persons with learning difficulties, it is important that DR management is personalised in such particular patient groups. First choice therapy needs to be individualised in these cases and may be intravitreal steroids rather than the standard choice of anti-VEGF agents. Some of these, but not all, are discussed in this document.
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Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Inhibidores de la Angiogénesis/uso terapéutico , Niño , Consenso , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/tratamiento farmacológico , Femenino , Humanos , Inyecciones Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Embarazo , Tomografía de Coherencia Óptica , Reino Unido , Factor A de Crecimiento Endotelial Vascular/uso terapéuticoRESUMEN
The title compound, (sodium magnesium) [magnesium iron(III) silicon] disilicate, (Na(0.97)Mg(0.03))(Mg(0.43)Fe(0.17) (3+)Si(0.40))Si(2)O(6), is isotypic with ordered P2/n omphacite. Its structure is characterized by single chains of corner-sharing SiO(4) tetra-hedra, extending along the c axis, which are crosslinked by bands of edge-sharing octa-hedra (site symmetry 2), statistically occupied by (Mg(2+) + Fe(3+) + Si(4+)). Between the bands built up of the octahedra are two non-equivalent highly distorted six-coordinated sites (site symmetry 2), statistically occupied by (Na + Mg). In contrast to omphacites, the great differences in size and charge between Mg(2+) and Si(4+) result in complete, rather than partial, ordering of Mg and Si into two distinct octa-hedral sites, whereas Fe(3+) is disordered between the two sites. The octa-hedron filled by (Mg + Fe) is larger and markedly more distorted than that occupied by (Si + Fe). The average (Mg + Fe)-O and ((VI)Si + Fe)-O bond lengths are 2.075 and 1.850â Å, respectively.