Macular Edema In Patients Research Articles

THE EFFECT OF AGE ON AFLIBERCEPT (EYLEA) RESPONSE IN DIABETIC MACULAR EDEMA.

To investigate the effect of age on aflibercept (Eylea) response in macular edema secondary to treatment-naive diabetic eyes. Two hundred seventy-three eyes of 273 treatment-naive patients with macular edema secondary to diabetes mellitus were enrolled in this study. The patients in the study were divided into the following 4 groups according to their ages: Group 1 (40-50 years), Group 2 (51-60 years), Group 3 (61-70 years), and Group 4 (>70 years). Three consecutive injections at intervals of 1 month were applied to all diabetic patients. The efficacy of the aflibercept treatment on macular edema according to age groups was assessed by optical coherence tomography by comparing the central foveal thickness (CFT) values and mean visual acuity changes after initial and three loading dose injections. After three consecutive aflibercept injections, the mean reduction of CFT in Groups 1, 2, 3, and 4 were -256.4 ± 110.9, -197.4 ± 96.4, -189.4 ± 110.8, and -186.2 ± 118.9 µm, respectively. The changes of CFT was significantly different between age groups (P = 0.003, analysis of covariance). The improvement of visual acuity was significantly different in each group (P < 0.001 in all groups, paired-samples t-test), and changes of visual acuity was significantly different between age groups (P < 0.05, analysis of covariance). In addition, ages of patients were correlated with the mean reduction of CFT and mean improvement of visual acuity for the whole study group (r = -0.183, P = 0.002 for CFT; r = -0.682, P < 0.001 for visual acuity, Pearson correlation). In this study, it was observed that the efficacy of aflibercept treatment was found to be more effective in younger patients in treatment-naive diabetic macular edema patients.

One-year real-life results on effect of intravitreal aflibercept in patients with diabetic macular oedema switched from ranibizumab.

To assess visual and optical coherence tomography-derived anatomical outcomes of treatment with intravitreal aflibercept (Eylea®) for diabetic macular oedema in patients switched from intravitreal ranibizumab (Lucentis®). Retrospective, cohort study. Ninety eyes (of 67 patients) receiving intravitreal anti-vascular endothelial growth factor therapy were included. This is a retrospective, real-life, cohort study. Each patient had visual acuity measurements and optical coherence tomography scans performed at baseline and 12 months after the first injection of aflibercept was given. We measured visual acuities in Early Treatment Diabetic Retinopathy Study letters, central foveal thickness and macular volume at baseline and at 12 months after the first aflibercept injection was given. Ninety switched eyes were included in this study. The mean (standard deviation) visual acuity was 63 (15.78) Early Treatment Diabetic Retinopathy Study letters. At baseline, the mean (standard deviation) central foveal thickness was 417.7 (158.4) μm and the mean macular volume was 9.96 (2.44) mm3. Mean change in visual acuity was +4 Early Treatment Diabetic Retinopathy Study letters (p = 0.0053). The mean change in macular volume was -1.53 mm3 in SW group (p = 0.21), while the change in central foveal thickness was -136.8 μm (p = 0.69). There was a significant improvement in visual acuity and in anatomical outcomes in the switched group at 12 months after commencing treatment with aflibercept for diabetic macular oedema.

Prevalence of and Risk Factors for Diabetic Retinopathy and Diabetic Macular Edema in Patients with Early- and Late-Onset Diabetes Mellitus

Purpose: The aim of this study was to compare the prevalence of diabetic retinopathy (DR) and diabetic macular edema (DME), as well as their risk factors in patients with early-onset diabetes (EOD, ≤40 years) and late-onset diabetes (LOD, >40 years). Methods: Patients were recruited from a community-based study, Fushun Diabetic Retinopathy Cohort Study (FS-DIRECT), conducted between July 2012 and May 2013 in China. The presence and severity of DR and DME were determined by a modified Early Treatment Diabetic Retinopathy Study (ETDRS) retinopathy scale of six-field fundus photographs. Results: A total of 1,932 patients (796 male, 41.2%) with gradable fundus photography were included. The prevalence of any DR and DME was 67.0% (95% confidence interval [CI]: 60.3–73.7%) and 39.3% (95% CI: 32.1–46.5%) in the EOD patients, respectively, which were both significantly higher than that in the LOD patients (DR: 41.9%, 39.6–44.2%, p < 0.001; DME: 14.4%, 12.7–16.1%, p < 0.001). Insulin use was associated with both the presence of DR and DME in both EOD and LOD patients. Besides insulin use, a high level of income (odds ratio [OR], 95% CI: 0.05, 0.01–0.51) was negatively associated with DR, and higher high-density lipoprotein (OR, 95% CI: 4.14, 1.44–11.91) was associated with DME among EOD patients. Conclusion: In this sample of patients with type 2 diabetes, both prevalence of DR and DME were apparently higher in patients who developed diabetes ≤40 years of age than those who developed it later.

The fellow eye effect of unilateral intravitreal conbercept injections in eyes with diabetic macular edema

To investigate whether intravitreal conbercept injection affects contralateral untreated eyes in bilateral diabetic macular edema (DME) patients. In this retrospective study, 15 patients (30 eyes) with type 2 diabetes were followed after bilateral DME diagnosis in the Department of Ophthalmology, Peking Union Medical College Hospital from 2015 to 2018. Patients underwent examinations including best corrected visual acuity (BCVA), slit-lamp microscopy, indirect ophthalmoscope, color fundus photography, fundus fluorescein angiography, optical coherence tomography, and glycated hemoglobin (HbA1c). Each patient received conbercept (0.5mg) intravitreally in the severe eye. Nonparametric Wilcoxon signed-rank tests and Pearson's correlation coefficient were used to assess changes in BCVA and central retinal thickness (CRT) and relations between BCVA changes in treated and untreated eyes, respectively. The mean follow-up time was 10.60 ± 2.29months, and the mean injection number of 15 treated eyes was 9.13 ± 0.68. HbA1c remained below 10% during treatment with no significant changes between the initial and final visits (7.81 ± 1.17 vs 7.62 ± 1.19%) (P = 0.576). In untreated eyes, CRT significantly decreased from the initial to final visits (368.93 ± 125.45 vs 306.27 ± 89.70μm) (P = 0.028). In untreated eyes, BCVA showed no significant difference between the initial and final visits (0.38 ± 0.30 vs 0.40 ± 0.30 logMAR) (P = 0.937), but BCVA changes in treated and untreated eyes were positively correlated (r = 0.527, P = 0.044). Intravitreal conbercept injection results in decreased CRT and increased BCVA in untreated eyes, which is consistent with the changes in treated eyes for patients with bilateral DME.

Increasing incidence of macular edema in excessive morning blood pressure surge in patients with retinal vein occlusion

Morning blood pressure surge (MBPS) had been known to be associated with hypertensive target organ injury and vascular events. Retinal vein occlusion (RVO) is also known to be related with underlying cardiovascular risk factors. This study investigated the effect of MBPS on patients with RVO. In total, 76 patients with RVO who had undergone systemic cardiovascular examination including a 24-hour ambulatory blood pressure monitoring, carotid artery intima media thickness, and pulse wave velocity were evaluated between January 2015 and February 2019. The MBPS was calculated as follows: mean systolic blood pressure measured over two hours after awakening minus mean systolic blood pressure measured during the one hour that included the lowest sleep blood pressure. Macular edema was significantly more prevalent in the MBPS group compared with the non-MBPS group. After adjusting for confounding factors, multivariate regression analyses revealed that MBPS independently predicted macular edema in patients with RVO [Odds ratio 4.75, 95% confidence interval 1.136–16.6, p = 0.015]. In conclusion, evaluating blood pressure patterns, especially MBPS, using 24-hour ambulatory blood pressure monitoring may be useful for assessing and predicting ophthalmologic outcome and may facilitate better blood pressure control in patients with RVO.

Prevalence and associated risk factors of diabetic retinopathy and macular oedema in patients recently diagnosed with type 2 diabetes

ObjectiveTo determine the prevalence of diabetic retinopathy (DR) and diabetic macular oedema (DME) and their associated risk factors in patients recently diagnosed with type 2 diabetes.Methods and analysisWe carried out...

Incidence of Cystoid Macular Edema in Patients after Cataract Surgery at a Tertiary Care Centre in Central India

Incidence of Cystoid Macular Edema in Patients after Cataract Surgery at a Tertiary Care Centre in Central India

Morphological and Functional Outcomes after Intravitreal Dexamethasone Injection for Macular Edema in Patients with Central Vein Occlusion at 48-Week Follow-Up.

Purpose The purpose of the study was to assess the efficacy of intravitreal dexamethasone implant (IDI: Ozurdex®) injection in eyes with macular edema due to retinal vein occlusion. Material and Method. A retrospective, nonrandomized study was conducted in patients with macular edema (ME) due to retinal vein occlusion (RVO) who undertook intravitreal Ozurdex® as first-line treatment. We performed a complete ocular exam including macular OCT. Results The mean BCVA (logMar) improved from 0.420.42 ± 0.23 logMar at baseline to 0.21 ± 0.23 logMar at 48 weeks in the BRVO group and from 0.72 ± 0.16 logMar at baseline to 0.31 ± 0.23 logMar at 48 weeks in the CRVO group. In both groups, CFT values decreased significantly compared to baseline (p < 0.0001 at each timepoint). Reinjection for recurrent macular edema after 18 weeks was indicated in five eyes (41.67%) in the BRVO group and in six eyes (25%) in the CRVO group. Cataract developed in two eyes (16.67%) in the BRVO group and in one eye (4.17%) in the CRVO group. The IOP was higher than 25 mmHg in two cases in the BRVO group (16.66%) and in three cases (8.33%) in the CRVO group. Conclusion Ozurdex® injected intravitreally significantly improved the mean CFT and BCVA in eyes with macular edema due to retinal vein occlusion.

Optimization of Diabetic Macular Edema Management in the Real World: A Model of Excellence in Retina Units: The EMUREX Initiative

Purpose: To define and develop a model of excellence for the clinical management of diabetic macular edema (DME) patients in a real-world setting. Methods: A multidisciplinary joint commission (5 ophthalmologists, 1 nurse, and 1 pharmaceutic) established a series of preliminary recommendations based on clinical guidelines and DME activity results from 8 Pilot Hospitals (PH). These were validated by members of each PH and a group of DME patients in discussion workshops. Thus, the validated guideline (VG) took into consideration different aspects, namely, main core points (ranging 0–100), criteria, and indicators. Finally, each PH own setting was compared to the VG in order to settle down a starting point to clinical excellence. Results: Mean PH score was 51.5 (range 30–65). As compared to their maximum, main points that showed best scores were Clinical Guidelines and Protocols (78%) and Portfolio of Services (73%). Topics reaching close to 50% scoring included Resources (55%), Innovation (54%), Care Process (53%), Organization (52%), and Leadership (50%). Lowest scores were observed in the Strategic Alliances (46%) and Staff (37%) points. Conclusions: Analysis of each PH by the VG delivered a global vision of the starting situation, especially focused in the identification of the different improvement areas. In order to further extend this model into the Public Health System, the effect of implementing it in different hospitals should be assessed to analyze its impact on daily clinical practice and health economics.

Assessment of the Dynamic Alteration of Choriocapillaris Vessel Density after Focal Laser Photocoagulation with OCT Angiography.

Purpose To evaluate the changes of choriocapillaris blood flow beneath laser lesions in noncenter-involved diabetic macular edema patients using optical coherence tomography angiography (OCTA). Methods This was a retrospective case-series study. We used OCTA to analyze the characteristics of the choriocapillaris blood flow beneath laser lesions before laser treatment and at several intervals after treatment. The choriocapillaris vessel density (CCVD) beneath the laser lesions was based on the OCTA images and was defined as the proportion of flow pixels in the selected area calculated using FIJI software through automatic binarization processing based on threshold methods. Results A total of 63 laser lesions in 8 eyes of 5 patients were included in this study. There was a significant decrease in the CCVD at 1 hour and 1 day following laser treatment (24.25% ± 5.04% and 22.00% ± 4.71%, respectively) when compared with the baseline value (39.09% ± 3.71%, all p < 0.001). The CCVD was 31.82% ± 4.53% in 1 week after laser treatment, which was significantly higher than that in 1 day after treatment (p < 0.001). The CCVD was 31.82% ± 4.53% in 1 week after laser treatment, which was significantly higher than that in 1 day after treatment (p < 0.001). The CCVD was 31.82% ± 4.53% in 1 week after laser treatment, which was significantly higher than that in 1 day after treatment (Conclusions OCTA image analysis can reflect changes in the choriocapillaris blood flow beneath laser lesions at different times following laser treatment in vivo. Spot size and laser energy may affect blood flow recovery.

Anti-angiogenesis therapy of diabetic macular edema in patients with primary open-angle glaucoma

To study the effect of anti-VEGF therapy on the structural and functional state of the retina and optic nerve in patients with DME and POAG. The study included 72 patients (132 eyes): the 1st group - 22 patients (40 eyes) with stage I POAG and DME, the 2nd group - 25 patients (46 eyes) with DME receiving anti-VEGF therapy. The 3rd group (control) consisted of 25 patients (46 eyes) with stage I POAG. The observation period lasted 24 months. The average number of injections was 8.48±3.65. The indicators for evaluation were: visual acuity, tonometry, perimetry, optical coherence tomography (OCT) of the optic nerve and macular region. By the end of the observation period, the increase in IOP in the groups was +0.82 (4.4%), 0.41 (2.4%), 0.65 (3.6%) mm Hg. In the group of comorbid patients, a small-scale increase trend of BCVA was noted: +0.05 (6.6%), a decrease in MD by -2.48 Db (92.1%), an increase in excavation volume by 0.16 (43.2%) mm3, decrease in the area of RA by 0.3 mm2 (12.7%). A decrease in retinal nerve fibers layer (RNFL) thickness of 6.55 μm (7.8%), mainly the superior (9.2%), inferior (7.3%) and nasal sectors (7.9%). Loss of GCL+IPL 8.68 μm (12.7%) in the superior (19%), superonasal (20.2%) and inferonasal (20.7%) sectors. The combined course of POAG and DME is accompanied by a decrease in the functional and structural parameters of the retina and optic nerve, and a higher rate of progression of glaucomatous optic neuropathy. Long-term results did not reveal a significant deterioration in the structural parameters of the optic disc and retina against the background of anti-VEGF therapy when comparing the study groups.

The usefulness of systemic inflammatory markers as diagnostic indicators of the pathogenesis of diabetic macular edema.

To investigate the usefulness of systemic inflammatory markers [i.e., white blood cell and platelet counts, mean platelet volume, and their ratios] as diagnostic markers of the pathogenesis of diabetic macular edema. The study cohort included 80 diabetic macular edema patients (40 with diabetic retinopathy and 40 without) and 40 healthy age- and sex-matched controls. Neutrophil, lymphocyte, monocyte, and platelet counts, and the mean platelet volume were determined from peripheral blood samples, and the monocyte/lymphocyte, platelet/lymphocyte, and mean platelet volume/lymphocyte, and neutrophil/lymphocyte ratios were calculated and compared among groups. The mean neutrophil/lymphocyte ratio of the diabetic macular edema and non-diabetic macular edema groups was higher than that of the control group, and the value of the diabetic macular edema group was higher than that of the non-diabetic macular edema group (p<0.001 in diabetic macular edema vs. control, p=0.04 in non-diabetic macular edema vs. control, and p=0.03 in diabetic macular edema vs. non-diabetic macular edema). A neutrophil/lymphocyte cutoff value of ≥2.26 was identified as an indicator of the pathogenesis of diabetic macular edema with a sensitivity of 85% and specificity of 74%. The mean platelet volume of the diabetic macular edema group was higher than those of the non-diabetic macular edema and control groups, while those of the non-diabetic macular edema and control groups were similar (diabetic macular edema vs. non-diabetic macular edema, p=0.08; diabetic macular edema vs. control, p=0.02; and non- diabetic macular edema vs. control, p=0.78). All other parameters were similar between groups (all p>0.05). The neutrophil/lymphocyte ratio and mean platelet volume of the diabetic macular edema group were higher than those of the non-diabetic macular edema and control groups. A neutrophil/lymphocyte ratio cutoff value of ≥2.26 was identified as an indicator of the pathogenesis of diabetic macular edema with high sensitivity and specificity. Moreover, the neutrophil/ lymphocyte ratio of the non-diabetic macular edema group was higher than that of the control group.

Comparision of Hyperreflective Foci after Treatment of Diabetic Macular Edema Patients between Intravitreal Injections

Comparision of Hyperreflective Foci after Treatment of Diabetic Macular Edema Patients between Intravitreal Injections

Aqueous Humor Cytokine Levels in Diabetic Macular Edema Patients with Cotton-Wool Spots.

Purpose To determine the characteristics of diabetic macular edema (DME) patients with cotton-wool spots (CWS). Methods We classified 80 treatment-naïve DME patients according to whether or not they had CWS involving macula and then compared the concentrations of interleukin- (IL-) 1β, IL-6, IL-8, IL-10, IL-17, placental growth factor, vascular endothelial growth factor (VEGF), and intercellular adhesion molecule (ICAM)-1 in the aqueous humor between the groups, as well as optical coherence tomography (OCT) findings, baseline characteristics, and intravitreal bevacizumab responsiveness. Results Aqueous levels of ICAM-1 and VEGF in the group with CWS were significantly higher than those in the non-CWS (control) group (p < 0.001 and p = 0.006, respectively). In multiple logistic regression analysis to identify factors associated with CWS, the aqueous ICAM-1 (≥0.36 ng/mL) was significantly associated with CWS (odds ratio = 13.26, p < 0.001). Based on OCT, ellipsoid zone (EZ) disruption distribution was significantly different between the two groups (p = 0.038). Regarding responsiveness to treatment, although there was no significant difference in central subfield thickness between the two groups after treatments, the best-corrected visual acuity was worse in the group with CWS. Conclusions The presence of CWS was accompanied by higher levels of aqueous ICAM-1. Based on OCT, EZ disruption was greater in DME patients with CWS, and their short-term visual prognosis was poorer.

Variability of diabetic macular edema in correlation with hypertension retinopathy in patients with diabetes mellitus and essential hypertension

Objective. This study aimed to determine the possible relationship between variability of diabetic macular edema associated with hypertension retinopathy in patients with type 2 diabetes mellitus and essential high blood pressure, in correlation with contrast sensitivity. Material and Methods. In order to accomplish the objective, this retrospective study evaluated the progression of diabetic macular edema in patients with high blood pressure during day time through measurements of the total macular volume and central macular thickness using optical coherence tomography and contrast sensitivity variations measured through Pelli Robson test, four times a day, along with glycemia and blood pressure measurements. Results. Our results showed a statistically significant correlation between the values of glycemia and central macular thickness, and between contrast sensitivity and macular thickness at every tested hour. Conclusions. The study revealed many statistically significant correlations involving blood pressure, blood glucose levels, Pelli Robson test and central macular thickness. Abbreviations: OCT = optical coherence tomography; DME = diabetic macula edema; SD-OCT = spectral domain optical coherence tomography; LOCS = lens opacities classification system; LE = left eye; ANOVA = analysis of variance.

Long-Term Follow-Up Changes of Central Choroidal Thickness Thinning after Repeated Anti-VEGF Therapy Injections in Patients with Central Retinal Vein Occlusion-Related Macular Edema with Systemic Hypertension

Purpose: We investigated the thinning of central choroidal thickness (CCT) following intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) drugs to treat central retinal vein occlusion (CRVO)-related macular edema in patients with and without systemic hypertension (HT) to assess the influence of repeated anti-VEGF therapy and HT on the choroid in CRVO eyes. Methods: We conducted a retrospective study involving 27 patients with CRVO-related macular edema from January 2014 to July 2017, with follow-ups exceeding 18 months. Visual acuity (VA), central retinal thickness (CRT), and CCT were evaluated before and after initial anti-VEGF drug treatment during follow-up. Results: The mean follow-up period was 35.2 months. Seventeen (63.0%) patients had HT. At 1 month after treatment, VA had improved in 21 (77.8%) patients, and CRT had decreased in 25 (92.6%). At the final visit, 22 (81.5%) showed improved VA, 19 (70.4%) had resolved macular edema, and the CCT had gradually become thinner with additional drug injections in all the patients. Furthermore, the mean CCT in HT patients (209.0 µm) was significantly lower than in non-HT patients (256.1 µm), and the mean injections were 7.8 and 5.3, respectively (p = 0.2067). Conclusion: The CCTs were thinner in eyes with HT than in eyes without HT both before and after the repeated anti-VEGF injections.

The effects of hyperbaric oxygen therapy on diabetic retinopathy: A preliminary study

The objective of this study was to prospectively assess the effect of hyperbaric oxygen therapy (HBOT) on diabetic retinopathy lesions and macular edema in patients undergoing the treatment for diabetic foot ulcers. We compared two groups: a first group including 25 patients with non-proliferative diabetic retinopathy treated by HBOT for foot ulcers, and a second group (control group) composed of 25 patients with diabetic retinopathy who did not receive HBOT. The HBOT protocol performed for the patients in the first group was: 30 sessions of 90 minutes each at 2.5 ATA with a mean frequency of five sessions per week. All patients had an ophthalmological exam at baseline (visual acuity, intraocular pressure, fundus exam), fundus photography and an OCT exam. A follow-up exam was performed at the conclusion of the HBOT. Compared to the control group, patients treated with HBOT showed a regression or stabilization of diabetic retinopathy lesions and a decrease in central macular thickness (CMT). Hyperbaric oxygen therapy may improve diabetic retinopathy and diabetic macular edema. This therapy may serve as an adjunctive treatment in the management of retinal ischemia and capillary hyperpermeability in diabetic retinopathy.

Factors associated with the duration of action of dexamethasone intravitreal implants in diabetic macular edema patients

We designed this study to determine the association between the duration of action of intravitreal dexamethasone implants and aqueous humor biomarkers or optical coherence tomography (OCT) findings of diabetic macular edema (DME) patients. We measured the concentrations of interleukin (IL)-1β, -8, -10, -17; placental growth factor; and vascular endothelial growth factor in the aqueous humor, and identified the number of hyperreflective foci (HF), grades of ellipsoid zone disruptions, and baseline central subfield thicknesses (CSTs) using OCT of patients with DME. The average duration of action of dexamethasone implants was 4.32 ± 1.18 months. In multivariate linear regression analyses, the duration of action was associated with aqueous IL-8 levels and the number of HF (β = −0.016, p = 0.037 and β = −0.073, p = 0.035, respectively). Multivariate logistic regression showed that the number of HF (>10) was significantly associated with a shorter duration (<4 months) of action (odds ratio: 17.17, p = 0.010). The duration of action of intravitreal dexamethasone implants in DME patients was associated with the level of aqueous IL-8 and the number of HF using OCT. Specifically, higher number of HF in the OCT was associated with a shorter duration of action.

Characteristics of diabetic macular edema patients with serous retinal detachment.

To determine characteristics of diabetic macular edema patients with serous retinal detachment (SRD).We classified naïve diabetic macular edema (DME) patients with or without SRD, and compared their baseline characteristics; intravitreal bevacizumab (IVB) responsiveness; aqueous concentrations of IL (interleukin)-1β, -2, -8, -10, -17, placental growth factor (PlGF), and vascular endothelial growth factor (VEGF). In addition, factors associated with the existence of SRD were identified.Of the 64 DME patients, 14 had SRD. The average levels of aqueous VEGF and PlGF were significantly higher in the SRD group than in the control group (P = .022 and P = .041, respectively). The best-corrected visual acuity (BCVA) and central subfield thickness (CST) did not differ significantly between the 2 groups at baseline or after 3 consecutive monthly IVBs. In multivariate logistic regression analysis, the level of aqueous VEGF was the only factor associated with the existence of SRD (odds ratio: 1.03; P = .038).Rather than aqueous inflammatory cytokines, levels of aqueous VEGFs were associated with the occurrence of SRD in DME patients. In terms of prognosis, the existence of SRD was not related with BCVA or CST changes.

Impact of Intravitreal Ranibizumab Therapy on Vision Outcomes in Diabetic Macular Edema Patients: A Meta-Analysis

Purpose: Evaluation of the impact of the injection frequency of ranibizumab on best-corrected visual acuity (BCVA) outcomes in patients with diabetic macular edema (DME). Methods: A meta-analysis of randomized controlled trials (RCTs) and real-world studies was performed to quantify the effect of ranibizumab treatment on BCVA and central foveal thickness (CFT) in DME as well as the relationship between the number of injections and the change in BCVA/CFT. Results: All combined sources (29 RCTs and 11 real-life studies) showed a significant increase in BCVA from baseline following anti-vascular endothelial growth factor (VEGF) treatment (8.2, 9.4, and 10.3 ETDRS letters gained after 12, 24, and 36 months of ranibizumab treatment, respectively). The largest changes in BCVA were observed in RCTs and the smallest in real-life studies at 12 months. A significant relationship was found between the number of injections and change in BCVA at 12 months. Conclusions: Inferior vision outcomes were observed in clinical practice compared with RCTs and might be partly attributable to administration of fewer anti-VEGF injections. Physicians should be aware that early and appropriate anti-VEGF treatment regimens are necessary to obtain the results reported in RCTs and help prevent irreversible vision loss in DME patients.