Treatment Of Diabetic Macular Edema Research Articles

Healthcare expenditure of intravitreal anti-vascular endothelial growth factor inhibitors compared with dexamethasone implant for diabetic macular oedema.

The aim of this study was to estimate the 1-year costs associated with treating diabetic macular oedema (DME) patients using current intravitreal anti-vascular endothelial growth factor (anti-VEGF) biologics compared with the dexamethasone implant. We conducted a descriptive cost-evaluation analysis using data from Oslo University Hospital and literature to compare three different intravitreal drugs for DME: bevacizumab, aflibercept and dexamethasone. Stratification of patients into 'Naive' or 'Switch' group was based on treatment history. We estimated the costs from healthcare and 'extended' healthcare perspectives. Sensitivity analysis evaluated the impact of various parameters. The average injections per patient per year for the Naive group (bevacizumab), Switch group (aflibercept) and dexamethasone were 9.5, 9.1 and 3.0 respectively. From a healthcare perspective, the 1-year costs for the Naive group were 15% lower (bevacizumab, €3619), and for the Switch group, 23% higher (aflibercept, €5226) compared with dexamethasone (€4252). The 'extended' healthcare perspective showed the cost per patient per year for bevacizumab remained nominally lower in the Naive group, while dexamethasone remained lower for the Switch group (€5116 for dexamethasone, compared to €4987 for bevacizumab and €6537 for aflibercept). From a primary healthcare perspective, the dexamethasone as a first-line DME treatment may increase economic costs in settings where bevacizumab is used off-label. Treating resistant DMEwith dexamethasone may reduce the costs and treatment burden compared with switching to aflibercept.

Intraocular Pressure Changes After Intravitreal Fluocinolone Acetonide Implant: Results from Four European Countries.

IntroductionThe 0.19 mg fluocinolone acetonide (FAc) intravitreal implant delivers a continuous intravitreal corticosteroid dose for the treatment of refractory diabetic macular oedema (DMO). The aim of this study was to assess the impact of an FAc intravitreal implant on intraocular pressure (IOP).MethodsWe retrospectively collected anonymised data on the patients’ characteristics, DMO treatment, and IOP and IOP-lowering treatments before and after the FAc intravitreal implant between September 2013 and March 2020 in several European centres.ResultsA total of 221 eyes from 179 patients were included. The mean follow-up duration was 13.4 (± 12.5, range 2.4–33.5) months. Overall, 194 eyes (88.2%) had received an intravitreal dexamethasone injection before the FAc intravitreal implant. For 25 eyes (11.3%) there was a history of glaucoma, and 52 eyes (23.5%) had previous IOP-lowering treatment. Mean IOP before injection was 14.7 (3.4) mmHg and increased to 16.9 (3.7) mmHg 12 months after injection (P < 0.0001). During follow-up, 55 eyes (24.9%) required the addition or initiation of topical IOP-lowering medication, only one patient (0.5%) had laser trabeculoplasty and one patient (0.5%) a minimally invasive glaucoma surgery, and no patient required incisional IOP-lowering surgery.ConclusionThe FAc intravitreal implant led to substantial IOP elevation. This elevation was monitored most of the time with addition or initiation of topical IOP-lowering medication.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40123-022-00504-z.

1-Year Fixed-Regimen Bevacizumab Treatment in DME-Vascular Network Image Analysis in Optical Coherence Tomography Angiography Study.

Purpose: To evaluate the effectiveness of intravitreal bevacizumab treatment in patients with diabetic macular edema (DME) by assessing retinal changes using AngioTool software (version 0.6a(02.18.14), National Cancer Institute, Bethesda, Maryland). Methods: A total of 27 eyes in patients with treatment-naïve DME were included in this prospective study. OCT-A images with a scan area of 6 × 6 mm were obtained. The DME patients with a central macular thickness (CMT) of ≥300 µm received nine bevacizumab injections within 12 months. The demographic, systemic, and ocular parameters, including the best-corrected visual acuity (BCVA) and CMT, were assessed. Explant area, vessels area, vessels percentage area, total number of junctions, total vessels length, average vessels length, the total number of endpoints, and mean lacunarity in the superficial capillary plexus (SCP) were calculated by using AngioTool software. Results: Twenty-nine eyes of DME patients were subjected to the final analysis. Bevacizumab treatment reduced CMT from 401.84 ± 84.54 µm to 328.93 ± 87.17 µm and improved BCVA from 65.18 ± 8.21 at baseline to 72.63 ± 7.43 letters among participants of the study. The anti-VEGF therapy showed no statistically significant changes in parameters calculated by AngioTool software in the study group of patients. Conclusion: The fixed-regimen intravitreal bevacizumab therapy was effective in treating DME. AngioTool software is an additional tool that could be used to assess vascular networks. However, the use of OCTA is unlikely to alter DME treatment regimens significantly or to find significant predictors. Perhaps using wide-angle devices or software will give a complete picture of the disease and prove to be more helpful.

Identifying Genetic Biomarkers Predicting Response to Anti-Vascular Endothelial Growth Factor Injections in Diabetic Macular Edema.

Intraocular anti-vascular endothelial growth factor (VEGF) therapies are the front-line treatment for diabetic macular edema (DME); however, treatment response varies widely. This study aimed to identify genetic determinants associated with anti-VEGF treatment response in DME. We performed a genome-wide association study on 220 Australian patients with DME treated with anti-VEGF therapy, genotyped on the Illumina Global Screening Array, and imputed to the Haplotype Reference Consortium panel. The primary outcome measures were changes in central macular thickness (CMT in microns) and best-corrected visual acuity (BCVA in ETDRS letters) after 12 months. Association between single nucleotide polymorphism (SNP) genotypes and DME outcomes were evaluated by linear regression, adjusting for the first three principal components, age, baseline CMT/BCVA, duration of diabetic retinopathy, and HbA1c. Two loci reached genome-wide significance (p < 5 × 10−8) for association with increased CMT: a single SNP on chromosome 6 near CASC15 (rs78466540, p = 1.16 × 10−9) and a locus on chromosome 12 near RP11-116D17.1 (top SNP rs11614480, p = 2.69 × 10−8). Four loci were significantly associated with reduction in BCVA: two loci on chromosome 11, downstream of NTM (top SNP rs148980760, p = 5.30 × 10−9) and intronic in RP11-744N12.3 (top SNP rs57801753, p = 1.71 × 10−8); one near PGAM1P1 on chromosome 5 (rs187876551, p = 1.52 × 10−8); and one near TBC1D32 on chromosome 6 (rs118074968, p = 4.94 × 10−8). In silico investigations of each locus identified multiple expression quantitative trait loci and potentially relevant candidate genes warranting further analysis. Thus, we identified multiple genetic loci predicting treatment outcomes for anti-VEGF therapies in DME. This work may potentially lead to managing DME using personalized treatment approaches.

Impact of retinal fluid in patients with diabetic macular edema treated with anti-VEGF in routine clinical practice

ObjectifLa présente étude visait à déterminer l'effet du liquide intrarétinien (LIR) et sous-rétinien (LSR) sur les résultats visuels en présence d'un œdème maculaire diabétique (OMD) traité par anti-VEGF (facteur de croissance endothélial vasculaire) en pratique clinique courante. NatureOn a eu recours à un logiciel d'intelligence artificielle doté de capacités d'apprentissage profond pour analyser des images obtenues par tomographie par cohérence optique (OCT, pour optical coherence tomography), qui nous a permis de quantifier le LIR, le LSR et le liquide rétinien total (LRT) au départ de même qu'après 3, 6 et 12 mois. Les variables de prédiction de la meilleure acuité visuelle corrigée (MAVC) ont été évaluées à l'aide de modèles de régression linéaire à effets mixtes. ParticipantsUn total de 220 yeux présentant un OMD (220 patients) au Cole Eye Institute de la Cleveland Clinic. MéthodesÉtude de cohorte non randomisée rétrospective. RésultatsLa MAVC s'est améliorée entre la visite initiale et le suivi à 12 mois (de 63,36 ± 14,72 à 68,49 ± 13,14 lettres selon l’étude ETDRS [Early Treatment Diabetic Retinopathy Study]; p < 0,001). L’épaisseur du sous-champ central s'est également améliorée entre la visite initiale et le suivi à 12 mois (de 411,74 ± 129,7 à 335,94 ± 116,91 mm; p < 0,001). La fréquence des injections par patient était de 8,25 ± 2,5 injections sur une période de 12 mois. Selon le modèle de régression linéaire à effets mixtes, lorsque les volumes du LRT, du LIR et du LSR de la région fovéale se situaient dans le quatrième quartile, on notait une baisse de la MAVC de –8,29 lettres (fourchette : de –10,96 à –5,62 lettres; p < 0,001), de –7,52 lettres (fourchette : de –10,3 à –4,74 lettres; p < 0,001) et de –6,93 lettres (fourchette : de –10,54 à –3,41 lettres; p < 0,001), respectivement. ConclusionsLe quartile le plus élevé des volumes du LRT, du LIR et du LSR s'accompagnait d'une détérioration des résultats visuels après l'administration d'un anti-VEGF pendant 12 mois dans le traitement de l'OMD. D'autres études calibrées pour examiner l'effet de l'anti-VEGF sur la morphologie du liquide rétinien pourront fournir un portrait plus clair du traitement personnalisé de l'OMD.

Treatment of Diabetic Macular Edema with Aflibercept and Micropulse Laser (DAM Study)

PurposeTo investigate the safety and efficacy of micropulse (MP) macular laser in combination with intravitreal aflibercept for the treatment of center-involved diabetic macular edema (CI-DME).MethodsA single-blind prospective randomized controlled pilot trial was performed. In total, 30 eyes of 30 patients with CI-DME and best corrected visual acuity (BCVA) between, and including, 20/30 and 20/400 were enrolled. Enrolled eyes were randomized to 2 groups. Group 1 received intravitreal aflibercept injections (IVT-AFL) with sham laser. Group 2 received IVT-AFL with MP laser. Both groups were followed every 4 weeks for 48 weeks and retreatment was performed on pro re nata basis according to preset criteria. The main outcome measure was the average number of intravitreal injections for each group at 48 weeks. Secondary outcome measures included changes in BCVA and central macular thickness (CMT) at 24 and 48 weeks.ResultsThe average number of intravitreal injections at 48 weeks was similar between the groups (8.5±3.3 in Group 1 vs 7.9±3.6 in Group 2, p=0.61). After 48 weeks, both groups demonstrated an improvement in BCVA and CMT. However, the difference in improvement between the groups was not statistically significant (p=0.18 for BCVA and p=0.57 for CMT).ConclusionIntravitreal injections of aflibercept led to improvements in BCVA and CMT at 24 and 48 weeks. Addition of MP laser to eyes in group 2 did not offer additional benefit in reducing treatment burden or improving CMT. Eyes that received MP laser showed a numerically greater improvement in BCVA, although this was not statistically significant.Clinicaltrials.gov IdentifierNCT03143192 March 8, 2017.

Efficacy and Safety of Aflibercept Therapy for Diabetic Macular Edema

Purpose:To assess the real-world efficacy and safety of aflibercept for the treatment of diabetic macular edema (DME).Methods:A systematic search was conducted across multiple databases. Articles were included if participants had DME and received aflibercept treatment for a minimum of 52 ± 4 weeks. Primary outcomes included changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). A risk of bias assessment of studies was completed, pooled estimates were obtained, and a meta-regression was performed. Information on adverse events was collected.Results:The search yielded 2112 articles, of which 30 were included. Aflibercept was more effective than laser photocoagulation functionally (12-month BCVA-weighted mean difference [WMD] = 10.77 letters, P < 0.001; 24 months = 8.12 letters, P < 0.001) and anatomically (12-month CMT WMD = –114.12 μm, P < 0.001; 24 months = –90.4 μm, P = 0.004). Compared to bevacizumab, aflibercept was noninferior at improving BCVA at 12 months (WMD = 1.71 letters, P = 0.34) and 24 months (WMD = 1.58 letters, P = 0.083). One study found that aflibercept was more effective than bevacizumab anatomically at 1 and 2 years (P < 0.001 at 12 and 24 months). Compared to ranibizumab, aflibercept rendered a greater improvement in BCVA at 1 year (WMD = 1.76 letters, P = 0.001), but not 2 years (WMD = 1.66 letters, P = 0.072). CMT was not significantly different between both therapies at 12 months (WMD = −14.30 μm, P = 0.282) and 24 months (P = 0.08). One study reported greater functional improvement with aflibercept compared with dexamethasone (P = 0.004), but inferiority in reducing CMT (P < 0.001). Meta-regression analysis demonstrated that dosing schedule was found to impact outcomes at 12 and 24 months, while study design and sample size did not impact outcomes at 12 months. There were minimal safety concerns using aflibercept therapy.Conclusions:Aflibercept is a safe and effective therapy option for DME in the clinical setting, performing superiorly to laser photocoagulation. Evidence regarding comparisons with bevacizumab, ranibizumab, and dexamethasone is mixed and limited.

Comparison of Aflibercept (Eylea®) with Ranibizumab (Lucentis®) in treatment of diabetic macular edema by Optical Coherence Tomography

Comparison of Aflibercept (Eylea®) with Ranibizumab (Lucentis®) in treatment of diabetic macular edema by Optical Coherence Tomography

IDF21-0489 Effect of COVID-19 disruption on Clinical study of Patients with Diabetic Macular Oedema Who Wore a Home-Use Sleep Mask

Background: Treatments for Diabetic Retinopathy and Diabetic Macular Oedema are typically clinically based, including intravitreal injections and laser photocoagulation. Use of a light mask worn overnight in a home setting has been proposed as a possible alternative, however patient adherence to home based treatment of chronic conditions is typically low, and thus methods have been sought to improve adherence and patient outcomes. The RENDER study was one such intervention, that was already underway when the COVID-19 pandemic resulted in lockdowns and significant disruption to clinic services in England.

Treatment of diabetic macular edema with intravitreal DEX Implant in Germany: Efficacy and safety in naïve and pre-treated patients in clinical practice.

To investigate the efficacy and safety of dexamethasone (DEX) implant in eyes with diabetic macular edema (DME) over 12-months. In this retrospective study charts from a single center were analysed, including naïve and pre-treated patients. Best corrected visual acuity (BCVA) and central retinal thickness (CRT) were evaluated at baseline, months 1-2, 3-4, 5-6 and 7-12. Data of 77 eyes were analysed (58.4% were pre-treated with anti-VEGF inhibitors). Mean baseline BCVA values for the whole sample, pre-treated and naïve patients, were 60.94 (SD 13.74), 60.85 (SD 13.80) and 61.01 (SD 13.86) letters, respectively. In the whole sample BCVA changes against baseline were significant (p < 0.05) at months 1-2, 3-4 and 7-12. In the pre-treated group changes were statistically significant at months 1-2 and 7-12. No statistically significant differences were found in the naïve group and between subgroups.In the whole group and the pre-treated group, CRT changes against baseline were significant (p < 0.05) at all time points, while in the naïve group changes were only significant at time point months 3-4. No statistically significant differences were found between subgroups.IOP increases were moderate and successfully managed with topical medication. After treatment with DEX implant, BCVA increased and CRT decreased significantly in the whole population at all time points. No significant differences were found between naïve and pre-treated patients. Changes in BCVA and CRT in the naïve group were not statistically significant. This was most likely attributable to the small sample size. The data underlines the importance of DEX implant as an efficacious and safe alternative to VEGF- inhibitors in real world practice.

The Fundus Structural and Functional Predictions of DME Patients After Anti-VEGF Treatments.

Diabetic retinopathy (DR) is an important complication with a high incidence of 34.6% in the diabetic populations. DR could finally lead to vision impairment without effective interventions, during which, diabetic macular edema (DME) is a key phase causing visual loss. Up to date, antivascular endothelial growth factor (anti-VEGF) therapy is the first-line treatment for DME which has achieved relatively better clinical outcomes than traditional treatments. However, there are several kinds of anti-VEGF medicines, and patients are sensitive to different anti-VEGF treatments. In addition, its effectiveness is unstable. Considering the patients’ need to accept continual anti-VEGF treatments and its price is comparatively high, it is clinically important to predict the prognosis after different anti-VEGF treatments. In our research, we used the demographic and clinical data of 254 DME patients and 2,763 optical coherence tomography (OCT) images from three countries to predict the fundus structural and functional parameters and treatment plan in 6 months after different anti-VEGF treatments. Eight baseline features combined with 11 models were applied to conduct seven prediction tasks. Accuracy (ACC), the area under curve (AUC), mean absolute error (MAE), and mean square error (MSE) were respectively used to evaluate the classification and regression tasks. The ACC and AUC of structural predictions of retinal pigment epithelial detachment were close to 1.000. The MAE and MSE of visual acuity predictions were nearly 0.3 to 0.4 logMAR. The ACC of treatment plan regarding continuous injection was approaching 70%. Our research has achieved great performance in the predictions of fundus structural and functional parameters as well as treatment plan, which can help ophthalmologists improve the treatment compliance of DME patients.

Efficacy and Safety of Intravitreal Fluocinolone Acetonide Implant for Chronic Diabetic Macular Edema Previously Treated in Real-Life Practice: The REALFAc Study.

Diabetic macular edema (DME) is the main cause of visual impairment in diabetic patients and a chronic disease requiring long-term treatments. The fluocinolone acetonide (FAc) implant has recently been approved to treat DME in patients considered insufficiently responsive to available therapies. This study evaluates the functional and anatomical efficacy of the FAc implant in real-life practice. A total of 62 eyes with chronic DME were included and followed for a mean of 13.9 (+7.5) months. Previous treatment included at least anti-vascular endothelial growth factor (VEGF) in 83.9% of eyes, dexamethasone implant (DEX-I) in 100% of eyes, vitrectomy in 29.0% of eyes, and laser photocoagulation (either panretinal or focal photocoagulation) in 75.8% of eyes. The mean baseline best corrected visual acuity (BCVA) was 64.0 (+/−17.2) letters (median: 67.5 letters) with a mean DME duration of 60.3 (+/−30.6) months. The maximum BCVA gain occurred at 21 months with a mean gain of 5.0 (+/−12.7) letters. A total of 50.0% of eyes gained ≥5 letters during follow-up. Patients with lower BCVA at baseline had the lowest final BCVA (p < 0.001) but the highest BCVA gain (p = 0.02). The best overall improvement in mean central macular thickness (CMT) occurred at 18 months (p < 0.0001). The improvement in BCVA was inversely associated with the decrease in CMT and showed a decrease when CMT increased (DME recurrence). According to the history of vitrectomy, we did not find any significant difference in mean final BCVA (p = 0.1) and mean BCVA gain (p = 0.2) between eyes previously vitrectomized or not. A total of 23 eyes (37.1%) required additional treatment for DME, and 17.7% required an IOP-lowering procedure during follow-up. In conclusion, this real-life observational study demonstrated the efficacy and safety of the FAc implant in patients with chronic DME already treated with other available therapies.

Собственный опыт применения бролуцизумаба

Purpose. Тo investigate the efficacy of a new anti-VEGF molecule – brolucizumab. Material and methods. Several clinical cases of treatment of age-related macular degeneration and diabetic macular edema with brolucizumab are presented in this article. Results. The effect of brolucizumab is high, visual acuity improves, clinical signs of the disease in the macular region decrease. Conclusion. As a result of clinical cases, high efficacy of brolucizumab is noted. Keywords: neovascularization, intravitreal injection, brolucizumab, age-related macular degeneration, macular edema.

EFFECT OF BASELINE CENTRAL RETINAL THICKNESS ON THE RESULTS OF TREATMENT OF DIABETIC MACULAR EDEMA WITH AFLIBERCEPT: REAL-LIFE EVIDENCE IN THE CZECH REPUBLIC.

Presentation of the 1-year results of aflibercept treatment in patients suffering fromdiabetic macular edema (DME) and comparison of the response to treatment of patients with different baseline central retinal thickness (CRT). This was a multicentre, retrospective observational study of a series of cases. Patients with DME were treated in a fixed regimen (5 injections at 1-monthly intervals and then injections at 2-monthly intervals). The period of follow-up was 12 months. The development of best corrected visual acuity (BCVA) and CRT was evaluated. Measurements were performed prior to the commencement of treatment and then after 4, 6, 8, 10, and 12 months. The therapeutically naive group consisted of 82 eyes of 79 patients. The total cohort of patients was divided into 3 groups according to the baseline values of CRT. The first group was composed of 28 eyes with baseline CRT &lt; 450 &#956;m (34.1%), the second included 25 eyes with CRT in the range of 450-550 &#956;m (30.5%), and the third group consisted of 29 eyes with baseline CRT &gt; 550 &#956;m (35.4%). The average baseline BCVA and SD in the first group was 66 ±7.1 letters ETDRS optotypes, and then 70 ±7 letters, 69.6 ±7.3 letters, and 71.3 ±7 letters at the follow-ups after 4, 8, and 12 months. The average baseline value of CRT and SD in the first group was 379 ±48.6 &#956;m, and then 337.1 ±76.5 &#956;m, 320.2 ±74.1 &#956;m, and 315.1 ±62.2 &#956;m after 4, 8, and 12 months. The average baseline BCVA and SD in the second group was 64.1 ±9.7 ETDRS letters, and then 66.9 ±10 letters, 70 ±9.9 letters, and 70.5 ±11.5 letters after 4, 8, and 12 months. The average baseline value of CRT and SD in the second group was 497.4 ±76.4&#956;m,and then 376.5 ±106.1 &#956;m, 360.8 ±70 &#956;m, and 351.3 ±91.3 &#956;m after 4, 8, and 12 months.In the third group, the average baseline value of BCVA and SD was 59.7 ±10.4 ETDRS letters, and then 65 ±10.6 letters, 64.8 ±9.6 letters, and 67 ±10 letters after 4, 8, and 12 months. The average baseline value of CRT and SD in the third group was 639.4 ±79.6 &#956;m, and then 396.7 ±147.1 &#956;m, 416.9 ±139.8 &#956;m, and 368.5 ±109.9 &#956;m after 4, 8, and 12 months. All these changes were statistically significant (p &lt; 0.05). Aflibercept treatment in a fixed regimen in patients suffering from DME results in a statistically significant improvement in BCVA and a decrease in CRT in the first year of treatment. Patients with a higher baseline CRT showed the best anatomical and functional results of the 1-year treatment with aflibercept.

Importance of ellipsoid zone line in the treatment of diabetic macular edema.

Introduction: Diabetic macular edema (DME) is a worst manifestation of diabetic retinopathy (DR). Current advanced techniques may reverse DME, usually evaluated by the improvement in visual acuity (VA). In clinical practice VA is not improved even after marked decrease in the macular thickness. Structures abnormalities for example to ellipsoid zone (EZ) may account for post treatment visual outcome.&#x0D; Objectives: To evaluate the relationship between Ellipsoid Zone line (EZ Line) and best corrected visual acuity (BCVA) after treating diabetic macular edema in type II diabetic patients.&#x0D; Methodology: For this prospective and observational study patients of type II diabetes mellitus with clinically significant macular edema (CSME) without proliferative diabetic retinopathy were recruited. The BCVA was recorded by Snellen Acuity Chart and discriminant values of macular thickness and EZ line defect were evaluated using Ocular Coherence Tomography at the time of presentation and during follow-up period. SPSS 22 version was used for results analysis&#x0D; Results: At 6th months follow-up, overall improvement in interruption of EZ line was good but statistically significant (P≤ 0.001) was found in sub class II a. The mean reduction in central sub foveal thickness (CSFT) was found significant (P≤ 0.001) in all class of EZ line but the mean value of BCVA in class I EZ line (70±SD18, P≤ 0.001) was better than class II (45±SD18, P-value = 0.021); and we did not find any correlation between the BCVA and level of interruption of EZ line after progressive decrease in CSFT (r = 0.210, P-value = 0.021).&#x0D; Conclusion: It has been concluded the by the quantitative measurement of retinal layer with OCT we can say that EZ line continuity is closely linked to visual outcome in eyes with macular edema.&#x0D; Keywords: Ellipsoid Zone Line, CME, Integrity of IS OS junction, CSFT&#x0D;

Characterization of Poor Visual Outcomes of Diabetic Macular Edema: The Fight Retinal Blindness! Project

To investigate the incidence, characteristics, and baseline predictors of poor visual outcomes in eyes with diabetic macular edema (DME) receiving intravitreal therapy in routine clinical practice. Observational study. Treatment-naïve eyes starting intravitreal therapy for DME between 2014 and 2018 tracked in the Fight Retinal Blindness! registry. We examined 2 groups with poor visual outcomes: (1) those with sustained vision loss of > 10 letters from baseline without recovery of visual acuity (VA); and (2) those with a VA of < 55 letters at 2 years. Respective controls were eyes that did not experience poor visual outcomes. Kaplan-Meier curves analyzed the proportion of eyes that experienced poor outcomes. Cox proportional hazards models evaluated the potential baseline predictors of poor outcomes. The proportion of eyes that experienced poor visual outcomes within 2 years of treatment initiation and its baseline predictors. The proportion of eyes with sustained VA of ≥ 10 letter loss was 14% at 2 years; 16% of eyes had VA of ≤ 55 letters 2 years after starting intravitreal therapy. Initial treatment with intravitreal corticosteroid was independently associated with a higher incidence of ≥ 10 letter loss (hazard ratio [HR], 3.21; 95% confidence interval [CI], 1.60-6.44; P < 0.01). No improvement in the VA at 3 months after starting treatment was associated with ≥ 10 letter loss (HR, 6.81; 95% CI, 4.11-11.27; P < 0.01) and VA of ≤ 55 letters at 2 years (HR, 4.28; 95% CI, 2.66-6.89; P < 0.01). The other factors related to higher risk of VA of ≤ 55 letters were older age (HR, 1.02 per year; 95% CI, 1-1.04; P = 0.04) and poor baseline VA (HR, 0.68 per 5 letters; 95% CI, 0.65-0.72, P < 0.001). Fourteen percent of eyes managed with intravitreal therapy in routine clinical care experienced ≥ 10 letter loss and 16% had VA of ≤55 letters 2 years after starting the treatment for DME. The identification of the incidence and predictors of poor outcomes provides a more accurate assessment of the potential benefit from intravitreal therapy.

Effectiveness of treatment by laser or intravitreal anti-vegf-bevacizumab or combination therapy (both Laser and Anti-VEGF) in diabetic macular edema

This study aimed to determine the effectiveness of treatment by laser or Intravitreal anti VEGF- Bevacizumab (IVB) or combined therapy (both laser and anti-VEGF) in diabetic macular edema (DME). A prospective observational study in which 90 eyes with diabetic macular edema (DME) were enrolled. According to patient compliance, they were divided in to 3 groups where there was 30 eyes in each group. Patients with DME who were treated with laser were observed (group A). Patients with DME who were treated with Intravitreal Bevacizuamb (IVB) were observed (group B).Patients with DME who were treated with both IVB and Laser were observed (group C). All patients underwent complete ophthalmic examination at baseline and at one and three months after treatment. The outcome measures were changes in Central macular thickness(CMT) and best corrected visual acuity(BCVA). A P value less than 0.05 considered statistically significant. One month after treatment, Group B showed more statistically significant reduction in CMT and improvement in BCVA than group A and group C(P&amp;#60;0.05). Three months after treatment, group C showed more statistically significant reduction in CMT and improvement in BCVA when compared to other two groups(P&amp;#60;0.05). Combined therapy with IVB and laser appeared to be superior to Laser alone or IVB alone in reducing macular thickness and improving visual acuity. Thus combined therapy can be considered as most effective treatment in DME.

Brolucizumab for the treatment of diabetic macular edema.

To review the available data supporting the use of brolucizumab in the treatment of diabetic macular edema (DME). Brolucizumab is a humanized single- chain variable antibody fragment (scFv), the smallest functional subunit of an antibody approved for intravitreal use. Three phase III studies demonstrate that at 52 weeks, brolucizumab has statistically superior anatomical outcomes of reducing retinal thickness (54.0-57.5% of brolucizumab treated eyes achieved central subfield thickness <280 μm compared to 40.1 - 41.4% of aflibercept treated eyes) and retinal fluid (present in 54.2-60.3% of brolucizumab treated eyes compared to 72.9-78.2% of aflibercept treated eyes). Brolucizumab also demonstrated a prolonged durability up to 16 weeks, thus reducing treatment burden. The visual outcomes appear noninferior to current anti-VEGF agents with an increased risk for intraocular inflammatory events (0.3-4.7% compared to 0.6-1.7%). Results from recent phase III trials showing the efficacy and safety of brolucizumab presents an additional therapeutic option in the DME treatment landscape. It can reduce treatment burden in DME with increased inter-treatment intervals while conferring efficacy in both functional and anatomical outcomes. Caution should be taken regarding the risks of intraocular inflammation, retinal vasculitis, and retinal vascular occlusion.

Trends in Prevalence and Treatment of Diabetic Macular Edema and Vision-Threatening Diabetic Retinopathy Among Medicare Part B Fee-for-Service Beneficiaries

While diabetes prevalence among US adults has increased in recent decades, few studies document trends in diabetes-related eye disease. To examine 10-year trends (2009-2018) in annual prevalence of Medicare beneficiaries with diabetes with a diagnosis of diabetic macular edema (DME) or vision-threatening diabetic retinopathy (VTDR) and trends in treatment. In this cross-sectional study using Centers for Medicare & Medicaid Services research identifiable files, data for patients 65 years and older were analyzed from claims. Beneficiaries were continuously enrolled in Medicare Part B fee-for-service (FFS) insurance for the calendar year and had a diagnosis of diabetes on 1 or more inpatient claims or 2 or more outpatient claims during the calendar year or a 1-year look-back period. Using diagnosis and procedure codes, annual prevalence was determined for beneficiaries with 1 or more claims for (1) any DME, (2) either DME or VTDR, and (3) anti-vascular endothelial growth factor (VEGF) injections, laser photocoagulation, or vitrectomy, stratified by any DME, VTDR with DME, and VTDR without DME. Racial and ethnic disparities in diagnosis and treatment are presented for 2018. In 2018, 6 960 823 beneficiaries (27.4%) had diabetes; half were aged 65 to 74 years (49.7%), half (52.7%) were women, and 75.7% were non-Hispanic White. From 2009 to 2018, there was an increase in the annual prevalence of beneficiaries with diabetes who had 1 or more claims for any DME (1.0% to 3.3%) and DME/VTDR (2.8% to 4.3%). Annual prevalence of anti-VEGF increased, particularly among patients with any DME (15.7% to 35.2%) or VTDR with DME (20.2% to 47.6%). Annual prevalence of laser photocoagulation decreased among those with any DME (45.5% to 12.5%), VTDR with DME (54.0% to 20.3%), and VTDR without DME (22.5% to 5.8%). Among all 3 groups, prevalence of vitrectomy in 2018 was less than half that in 2009. Prevalence of any DME and DME/VTDR was highest among Hispanic beneficiaries (5.0% and 7.0%, respectively) and Black beneficiaries (4.5% and 6.2%, respectively) and lowest among non-Hispanic White beneficiaries (3.0% and 3.8%, respectively). Among those with DME/VTDR, anti-VEGF was most prevalent among non-Hispanic White beneficiaries (30.3%). From 2009 to 2018, prevalence of DME or VTDR increased among Medicare Part B FFS beneficiaries alongside an increase in anti-VEGF treatment and a decline in laser photocoagulation and vitrectomy.

Managed care opportunities and approaches to select treatment for sight preservation.

Anti-vascular endothelial growth factor therapies have become the mainstay of treatment for both diabetic macular edema and neovascular age-related macular degeneration. This treatment is imperative for vision preservation including visual acuity. However, treatment burdens include high costs, frequent injections, continued visual loss, and loss of ability to perform day-to-day functions. Although clinical trial data have provided insights to treatment options and protocols, real-world patient experiences and adherence to therapies do not often mimic clinical trials as patients cannot fully adhere to their treatment schedule, leading to poor disease outcomes. Payers may consider various strategies such as step therapies, fee schedule management, and driving utilization through specialty pharmacies to contain costs. However, it is important to recognize not all patients will respond to a one-size-fits-all approach to treatment, warranting a more personalized approach.