RESUMEN
Objectives: This study aimed to report the demographic and clinical characteristics of diabetic macular edema (DME) patients treated with intravitreal injection (IVI) of anti-vascular endothelial growth factors (anti-VEGF) and provide an overview of outcomes during routine clinical practice in Türkiye. Materials and Methods: This retrospective, real-world study included 1,372 eyes (854 patients) treated with a pro re nata protocol by 21 ophthalmologists from 8 tertiary clinics on the Asian side of the Marmara region of Türkiye (MARMASIA Study Group). Five cohort groups were established by collecting the patients' baseline and 3, 6, 12, 24, and 36-month follow-up data, where each subsequent cohort may include the previous. Changes in best-corrected visual acuity (BCVA, approximate ETDRS letters) and central macular thickness (CMT, µm), number of visits and IVI, and rates of anti-VEGF switch and intravitreal dexamethasone implant (IDI) combination were evaluated. Results: The 3, 6, 12, 24, and 36-month cohorts included 1372 (854), 1352 (838), 1185 (722), 972 (581), and 623 (361) eyes (patients), respectively. The mean baseline BCVA and CMT were 51.4±21.4 letters and 482.6±180.3 µm. The mean changes from baseline in BCVA were +7.6, +9.1, +8.0, +8.6, and +8.4 letters, and in CMT were -115.4, -140.0, -147.9, -167.3, and -215.4 µm at the 3, 6, 12, 24, and 36-month visits (p<0.001 for all). The median cumulative number of anti-VEGF IVI was 3.0, 3.0, 5.0, 7.0, and 9.0, respectively. The overall anti-VEGF switch and IDI combination rates were 18.5% (253/1372 eyes) and 35.0% (480/1372 eyes), respectively. Conclusion: This largest real-life study of DME from Türkiye demonstrated BCVA gains inferior to randomized controlled trials, mainly due to the lower number of IVI. However, with the lower baseline BCVA and higher IDI combination rates in our cohorts, these gains were relatively superior to other real-life study counterparts.
Asunto(s)
Diabetes Mellitus , Retinopatía Diabética , Edema Macular , Humanos , Edema Macular/diagnóstico , Edema Macular/tratamiento farmacológico , Edema Macular/etiología , Retinopatía Diabética/complicaciones , Retinopatía Diabética/diagnóstico , Retinopatía Diabética/tratamiento farmacológico , Factores de Crecimiento Endotelial/uso terapéutico , Dexametasona , Estudios Retrospectivos , Turquía , Diabetes Mellitus/tratamiento farmacológico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
AIMS: This study aims to compare the effectiveness of treatment between anti-vascular endothelial growth factor (anti-VEGF) agents in diabetic macular edema (DME) patients with disorganization of retinal inner layers (DRIL). Epiretinal membrane, serous macular detachment, ellipsoid zone (EZ) disorder, external limiting membrane (ELM) disorder, and hyperreflective foci were also examined. METHODS: Patients treated for DME and also had DRIL were included in the study. The study design was retrospective and cross-sectional. The complete ophthalmologic records and imaging were scanned at the beginning, 3rd-month, 6th-month, and 12th-month follow-up, and the treatments administered were recorded. Anti-VEGF agents administered to the patients were examined in three groups: bevacizumab, ranibizumab, and aflibercept. RESULT: A total of 141 eyes of 100 patients were included in our study. One hundred and fifteen eyes (81.6%) had a BCVA of 0, 5, or less at the beginning. There was no statistically significant difference between the three groups regarding initial BCVA and CMT and the change in BCVA and CMT at the beginning and the 12th month (p > 0.05). There was a negative correlation between EZ and ELM disorders in patients and the change in BCVA at 12 months (r: 0.45 p < 0.001, r: 0.32 p < 0.001, respectively). The number of injections over five was positively correlated with the change in CMT but not with BCVA (r: - 2.35 p = 0.005 and r: 0.147 p = 0.082, respectively). CONCLUSIONS: No statistically significant difference was found between anti-VEGF agents when treating DME patients with DRIL. In addition, we have shown that anatomically better results were obtained in those who had five or more injections, although not in terms of BCVA.