Treatment Of Diabetic Macular Edema Research Articles

Patient and Physician Perspectives of Diabetic Retinopathy and Diabetic Macular Edema Diagnosis, Treatment and Progression: A Podcast Article.

Diabetic retinopathy (DR) is one of the leading causes of vision loss among people of working age. However, people with diabetes are often unaware of the importance of DR screening for preserving vision, highlighting the importance of patient education about DR and DR-related ocular and systemic comorbidities. In this podcast, three patients with different stages of DR and two ophthalmologists exchanged their views on diagnosis, treatment, and progression of DR and diabetic macular edema. The discussion revealed that DR affects not only the physical aspects of patients' lives but also their mental wellbeing. The challenges of a DR diagnosis can be compounded by communication gaps that exist between patients, physicians, and the pharmaceutical industry. Development of new therapies is currently informed mainly by physician perspectives. However, the large burden of current treatments calls for new therapeutic approaches that meet patients' needs better. The preferred method of treatment administration can differ from patient to patient and the choices between treatments that necessitate repeated visits, monitoring, and at-home care must be discussed. As such, going forward it is crucial to consider both the physician and patient perspectives in shaping the clinical landscape of DR.

Evolving Practice Patterns of Young Retinal Specialists: A Five-Year Comparison of Treatment and Surgical Preferences

PurposeTo describe trends in demographics and practice patterns of young retina specialists over a five-year follow-up period. DesignA cross-sectional study of young retinal specialists conducted through an online social media platform to evaluate practice patterns for common conditions. MethodsAn anonymous survey was performed among U.S.-based young retinal specialists from a variety of practice environments in early stages of practice between August and September 2022. Results were compared to survey results from 2017. ResultsIn 2022, the survey population included 358 members with 101 respondents compared to 44 respondents in 2017. Most respondents preferred bevacizumab as first-line treatment for foveal-involving diabetic macular edema (DME) (60%), vein occlusions (54%), and macular degeneration (56%). Aflibercept was more popular as first-line for DME patients with poor vision (51%) compared to those with good vision (18%). For proliferative diabetic retinopathy (PDR) without macular edema, respondents prefer panretinal photocoagulation alone (43%) or in combination with anti-VEGF (48%) over anti-VEGF alone (10%). Respondents repaired rhegmatogenous retinal detachments using combined vitrectomy-buckle (20%), primary scleral buckle (10%), and pneumatic retinopexy (PR) (10%). The percentage of respondents who have used PR at least once increased significantly from 2017 to 2022. From 2017 to 2022, more respondents use masks (29.5% to 82.8%) and post-injection antibiotics (2.3% to 16.0%) when performing injections while a smaller minority use topical gel anesthesia (34.1% to 15.5%). ConclusionsSurvey results suggest more providers are more likely to observe good visual acuity in diabetic edema and use laser alone in PDR without edema. In addition, longitudinal trends show increased use of PR, masks and post-injection antibiotics, and decreased use of topical gel anesthesia.

Association between renal function and the Treatment of Diabetic Macular Edema in Long-Term Cohort Study

To determine the correlation between the severity of chronic kidney disease (CKD) and treatment of diabetic macular edema (DME). The retrospective 2-year cohort study included eyes with DME confirmed using spectral-domain optical coherence tomography in Taipei Veterans General Hospital, Taiwan, between 2010 and 2020. All the eyes were treated with an intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) during regular follow-up around 2 years. They were categorized into 3 different groups: an estimated glomerular filtration rate ≥ 60 (mL/min per 1.73 m2) (group A), < 60 (group B), and patients undergoing hemodialysis (group C). The main outcome measures were (1) visual improvement, (2) structural improvement, and (3) the injection frequency of anti-VEGF in the different groups. In this study, 167 eyes from 120 patients were enrolled. Compared with groups B and C, the eyes in group A experienced the only significant visual improvement at month 3, month 6, and month 12 (P = 0.0001, 0.0002, 0.0013, respectively). The presence of subretinal fluid and intraretinal cysts was significantly decreased in groups A and B. In the treatment frequency analysis, the number of injections was the highest in group A and lowest in group C during the study period (P = 0.04). The severity of CKD had an impact on the DME treatment. The less severe CKD was, the greater the visual improvement that could be achieved. In addition, relatively poor renal function required a lower anti-VEGF injection frequency. The active prevention of the progression of CKD may play a key role in DME treatment.

Impact of Aflibercept vs Dexamethasone Treatment on Epiretinal Membrane Formation in Eyes with Diabetic Macular Edema.

This study aimed to investigate the impact of aflibercept and dexamethasone (DEX) on the formation of epiretinal membrane (ERM) and their treatment outcomes in eyes with diabetic macular edema (DME). In this retrospective cohort study, medical records of 124 eyes from 429 patients diagnosed with DME were reviewed between June 2017 and June 2019. Patients were categorized into two groups: the aflibercept group (67 eyes) and the DEX group (57 eyes). The primary endpoint was the secondary ERM incidence following intravitreal treatments and its correlation across different medications. Secondary endpoints included longitudinal changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). Over a 24-month follow-up, eyes treated with DEX had approximately a fourfold higher incidence of ERM development compared to aflibercept [hazard ratio (HR) = 3.97, p = 0.02]. These eyes also showed worse BCVA (p = 0.059) and increased CMT (p = 0.004), despite requiring fewer total injections (p = 0.000) in the survival analysis model. The cumulative probability of ERM formation was 13.7%. Additionally, DME eyes exhibited poor functional and anatomical outcomes after developing ERM, while age, A1c level, DR severity, initial BCVA and CMT, lens status, and previous laser treatment were not associated with an elevated incidence of ERM formation. Intravitreal DEX implantation in DME eyes resulted in a higher incidence of secondary ERM formation compared to aflibercept over a 2-year period. The therapeutic efficacy for DME was diminished following ERM development, leading to worse anatomical outcomes. New therapeutic approaches should be explored to prevent ERM formation while maintaining both anatomical and functional outcomes in DME treatment.

Alteration of treatment choices and the visual prognosis for diabetic macular edema in the era of anti-VEGF drugs: Analysis of the STREAT-DME 2 study.

To assess the real-world outcome of best-corrected visual acuity (BCVA) following 2-year intervention for treatment-naïve diabetic macular edema (DME) since the approval of anti-vascular endothelial growth factor (VEGF) therapy. A total of 1,780 treatment-naïve eyes with DME for which intervention was initiated between 2015 and 2019, and which were followed for 2 years, were extracted from the longitudinal medical records of 37 retinal disease institutions in Japan. Interventions included anti-VEGF therapy, topical corticosteroid therapy, macular photocoagulation, and vitrectomy. The baseline and final BCVA, and the number and timing of interventions were recorded. Eyes were classified according to the year in which intervention was initiated. Over a 2-year period, BCVA improved annually, finally reaching 7 letters. The proportion of eyes in which good vision was maintained (BCVA >20/40) increased to 73.3% in the latest period. The administration of anti-VEGF therapy remained stable, accounting for approximately 90% of eyes. Notably, the proportion of eyes receiving anti-VEGF drugs as first-line treatment increased dramatically to approximately 80%. Anti-VEGF therapy has become the first-line treatment since the approval of anti-VEGF drugs for DME. These findings reflect the evolution of DME treatment and highlight the superiority of anti-VEGF therapy and its increased uptake over time.

Role of Suprachoroidal versus Intravitreal injection of triamcinolone: In diabetic macular edema.

Objective: To assess the efficacy of suprachoroidal versus intravitreal injection of triamcinolone in diabetic macular edema. Study Design: Randomized Controlled Trial. Setting: Department of Ophthalmology, Ziauddin Hospital Kemari, Karachi. Period: 1st November 2022 and 30th October 2023. Methods: The study observed 71 eyes of 59 patients diagnosed with Diabetic macular edema. All patients that met the inclusion criteria were divided into two groups, Group A Suprachoroidal Triamcinolone and Group B Intravitreal Triamcinolone. Results: This research encompasses 71 eyes from 59 patients diagnosed with diabetic macular edema, divided into two groups based on their chosen treatment. Group A consisted of 34 patients, whereas Group B comprised 37 patients. The average age of patients in both groups was 43.6±6.2. Baseline visual acuity and macular thickness were recorded in both groups and compared after treatment. Significant improvement was observed in both groups, particularly notable in the 3rd month. The suprachoroidal triamcinolone injection exhibited a more stable response, accompanied by lower complication rate. Conclusion: In conclusion, the comparative analysis of Suprachoroidal Triamcinolone acetate and Intravitreal Triamcinolone Acetate showed a more significant improvement in IOP and CMT in the suprachoroidal group as compared to intravitreal. Hence Suprachoroidal injection was seen as the treatment of choice in treatment of Diabetic Macular Edema.

7064 The Newest LLMs: Can They Help Patients With Diabetic Macular Edema?

Abstract Disclosure: G. Wu: None. E. Cheng: None. K. Rosen: None. W. Zhao: None. A. Wong: None. V.V. Toram: None. Background: Cohere and Claude, the newest LLMs, use retrieval augmented generation (RAG) architecture versus ChatGPT and Bard, which use Transformer architecture and can supplement knowledge gaps from the internet. RAG supplements knowledge gaps with vector databases to answer user prompts. Diabetic macular edema is a common visual complication of diabetes. According to the CDC, 38.4 million people have diabetes, and approximately 750,000 Americans have diabetic macular edema and may have vision loss. Due to their prevalence, AI could be applied to address these conditions. Purpose: To evaluate four different LLMs to see which one provides the most accurate information for diabetic macular edema treatment. Methods: We queried Cohere (Coral) + Claude and ChatGPT + Bard. 1) I have diabetic macular edema and I am 40 y/o white male, with 15 years of diabetes and I cannot pass the driving test in California. What will it cost me per year for treatment? I have no health insurance. 2) I am 40 years old, white male, and have had diabetes for 15 years. I was told that I cannot pass the driving test in California. How much will I pay for one year of treatment? I have no health insurance. We use a custom scoring system that has the following metrics. We then take a weighted average: Readability: 20% Accuracy: 40% Helpfulness: 30% Specificity: 10% Results: Cohere Coral: Q1=Read 16/20 | Acc 36/40 | Help 28/30 | Spec 9/10 | Total 89/100 | Q2=Read 14/20 | Acc 34/40 | Help 26/30 | Spec 8/10 | Total 82/100 Claude: Q1=Read 18/20 | Acc 32/40 | Help 26/30 | Spec 7/10 | Total 83/100| Q2= Read 18/20 | Acc 30/40 | Help 25/30 | Spec 6/10 | Total 79/100 ChatGPT: Q1=Read 18/20 | Acc 28/40 | Help 25/30 | Spec 6/10 | Total 77/100| Q2= Readability 18/20 | Acc 28/40 | Help 24/30 | Spec 6/10 | Total 76/100 Bard: Q1=Total 80/100| Q2=Read 16/20 | Acc 30/40 | Help 27/30 | Spec 7/10 | Total 80/100 Cohere Coral consistently provided the most detailed and accurate information, leading with average scores of 85.5/100. Claude, ChatGPT, and Bard followed with scores of 81, 76.5, and 80, respectively. Conclusions: In our small study, RAG-based LLMs can provide accurate and instantaneous health education. Physicians should follow the new, evolving LLMs as it may affect patient education. Presentation: 6/1/2024

Surgical treatment of diabetic macular edema

Surgical treatment of diabetic macular edema

Predictive value of optical coherence tomography angiography in management of diabetic macular edema

BackgroundOptical coherence tomography angiography (OCTA) is a relatively new extension of Optical coherence tomography (OCT) that generates non-invasive, depth-resolved images of the retinal microvasculature which allows for the detection of various features of diabetic retinopathy.ObjectivesThis study aimed to detect biomarkers that may predict an early anatomical response to the treatment of diabetic macular edema (DME) with intravitreal ranibizumab (IVR) by means of OCTA.Patients and methodsThis prospective interventional study was undertaken on 111 eyes of 102 naïve participants who had diabetic macular edema; enrolled patients were evaluated by taking a complete ophthalmologic history, examination and investigations by use of a pre-designed checklist involving Optical Coherence Tomography Angiography.ResultsRegarding the best corrected visual acuity (BCVA) the Mean ± SD was 0.704 ± 0.158 preoperatively and 0.305 ± 0.131 postoperatively in good responder patients; and was 0.661 ± 0.164 preoperatively and 0.54 ± 0.178 postoperatively in poor responders. The central macular thickness (CMT) was 436.22 ± 54.66 μm preoperatively and 308.12 ± 33.09 μm postoperatively in good responder patients; and was 387.74 ± 44.05 μm preoperatively and 372.09 ± 52.86 μm postoperatively in poor responders. By comparing the pre injection size of the foveal avascular zone area (FAZ-A) in both groups, it found that the mean ± SD of FAZ-A was 0.297 ± 0.038 mm in good responder patients compared to 0.407 ± 0.05 mm in non-responder patients. The preoperative superficial capillary plexus (SCP) foveal vascular density (VD) was 24.02 ± 3.01% in good responder patients versus 17.89 ± 3.19% um in poor responders. The preoperative SCP parafoveal VD was 43.06 ± 2.67% in good responder patients versus 37.96 ± 1.82% um in poor responders. The preoperative deep capillary plexus (DCP) foveal VD was 30.58 ± 2.89% in good responder patients versus 25.45 ± 3.14% in poor responders. The preoperative DCP parafoveal VD was 45.66 ± 2.21% in good responder patients versus 43.26 ± 2.35% um in poor responders, this was statistically significant.ConclusionOCTA offers an accurate measurement for VD in the macula as well as the FAZ-A which could be used to predict an early anatomical response of anti-VEGF treatment in DME.

Ranibizumab Monotherapy versus Ranibizumab Combined with Adjuvant Subthreshold Micropulse Yellow Laser in Treatment of Diabetic Macular Edema

Ranibizumab Monotherapy versus Ranibizumab Combined with Adjuvant Subthreshold Micropulse Yellow Laser in Treatment of Diabetic Macular Edema

Short pulse grid and subthreshold micropulse laser (the sandwich grid) plus intravitreal ranibizumab for the treatment of diabetic macular edema

ObjectiveTo investigate the effects of two laser treatment procedures combined, short pulse grid laser (SP) and subthreshold micropulse laser (MP) (the sandwich grid [SWG] technique), plus intravitreal ranibizumab (IVR) on central subfield thickness (CSFT), best-corrected visual acuity (BCVA) and macular sensitivity in patients with diabetic macular edema (DME).MethodsForty-five eyes (of 33 patients) with center-involving DME were treated with the SWG laser technique plus IVR and followed for 12 months. Laser treatment was performed at baseline: SP laser spots were placed in a grid pattern in the macular area (500 µm from the fovea) according to the extension of DME; subsequently, MP laser was delivered up to the edge of the fovea. MP laser re-treatment sessions could be performed every 3 months if DME was present and CSFT was ≥ 300 μm on SD-OCT. IVR injection was performed at baseline and repeated monthly if CSFT > 300µm. Preoperatively and monthly, ophthalmological examination was performed including measurements of BCVA, CSFT, and macular sensitivity.ResultsOne-year follow-up data is available for 37 eyes of 27 patients. Mean ± SE CSFT (µm) was 509.36 ± 25.14 and 325.76 ± 15.34 at baseline and 12 months, respectively. A significant reduction in mean CSFT was observed at all study visits compared to baseline (p < 0.001). Mean ± SE BCVA (logMAR) was 0.62 ± 0.04 and 0.45 ± 0.04 at baseline and 12 months, respectively. A significant improvement in mean BCVA was observed at all study visits compared to baseline (p < 0.001). Mean ± SE macular sensitivity (dB) was 17.85 ± 0.80 and improved to 19.05 ± 0.59 after one year of follow-up (p = 0.006). The mean number of IVR injections was 8.29 ± 0.63. The mean number of MP laser procedures including the initial SWG laser session was 3.67 ± 0.22. No ocular or systemic adverse effects were observed.ConclusionThe SWG laser technique plus IVR was associated with significant improvement in macular edema, BCVA, and macular sensitivity in patients with center-involving DME.Clinical Trial Number (CAAE)22969019.4.0000.5440.

Dynamics of Treatment Response to Faricimab for Diabetic Macular Edema.

This study analyzes the dynamics of short-term treatment response to the first intravitreal faricimab injection in eyes with diabetic macular edema (DME). This retrospective, single-center, clinical trial was conducted at the Department of Ophthalmology, University Hospital Zurich. Patients with treatment-naïve and pretreated DME were included. Patient chart data and imaging were analyzed. Safety and efficacy (corrected visual acuity (CVA), central subfield thickness (CST), and signs of intraocular inflammation (IOI)) of the first faricimab intravitreal therapy (IVT) were evaluated weekly until 4 weeks after injection. Forty-three eyes (81% pretreated) of 31 patients were included. Four weeks after the first faricimab IVT, CVA remained stable and median CST (µm) decreased significantly (p < 0.001) from 325.0 (293.5-399.0) at baseline to 304.0 (286.5-358.0). CVA at week 4 was only associated with baseline CVA (p < 0.001). CST was the only predictive variable (p = 0.002) between baseline and week 4 CST. Weekly safety assessments did not show any sign of clinically significant IOI. This study suggests faricimab is an effective treatment for (pretreated) DME, showing structural benefit 1 month following the first injection without short-term safety signals.

Identification and Activity Study of an Impurity Band Observed in the nrSDS-PAGE of Aflibercept.

Aflibercept is a biopharmaceutical targeting vascular endothelial growth factor (VEGF) that has shown promise in the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) in adults. Quality control studies of aflibercept employing non-reduced SDS-PAGE (nrSDS-PAGE) have shown that a significant variant band (IM1) is consistently present below the main band. Considering the quality control strategy of biopharmaceuticals, structural elucidation and functional studies are required. In this study, the variant bands in nrSDS-PAGE were collected through electroelution and identified by peptide mass fingerprinting based on liquid chromatography-tandem MS (LC-MS/MS). This variant was expressed using knob-into-hole (KIH) design transient transfection for the detection of ligand affinity, binding activity and biological activity. The variant band was formed by C-terminal truncation at position N99 of one chain in the aflibercept homodimer. Then, this variant was successfully expressed using KIH design transient transfection. The ligand affinity of the IM1 truncated variant was reduced by 18-fold, and neither binding activity nor biological activity were detected. The efficacy of aflibercept is influenced by the loss of biological activity of the variant. Therefore, this study supports the development of a quality control strategy for aflibercept.

Interpretation of SD-OCT imaging data in real-life conditions versus standardized reading centre analysis in eyes with diabetic macular oedema or macular oedema secondary to retinal vein occlusion: 24-month follow-up of the ORCA study.

As part of the prospective, non-interventional OCEAN study, the ORCA module evaluated physicians' spectral domain optical coherence tomography (SD-OCT) image interpretations in the treatment of diabetic macular oedema (DME) or macular oedema (ME) secondary to retinal vein occlusion (RVO). Presence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) was evaluated independently by physicians and reading centres (RCs) on 1612 SD-OCT scans of 133 patients diagnosed with either DME or ME secondary to RVO. Agreement between physicians and RCs was calculated for both cohorts individually and as a combined ME cohort. Physicians' treatment decisions were analysed related to the results of the OCT-evaluations. For the combined ME cohort, presence of IRF/SRF was recorded by RCs in 792/1612 (49.1%) visits and by physicians in 852/1612 (52.9%) visits, with an agreement regarding presence or absence of foveal fluid in 70.4% of cases. In 64.4% (510/792) of visits with RC-detected foveal IRF and/or SRF no injection was given. In 30.3% of these visits with foveal fluid no reason was identified for a 'watch and wait' approach indicating possible undertreatment. BCVA deterioration was seen in a quarter of these eyes at the following visit. Despite good agreement between physicians and RCs to recognize SRF and IRF, our data indicate that omitting injections despite foveal involvement of fluid is frequent in routine clinical practice. This may put patients at risk of undertreatment, which may negatively impact real-life BCVA outcomes. www. gov , identifier NCT02194803.

Aflibercept in the clinical routine: the AURIGA study : The 24-month results of the German cohort of treatment-naïve patients with diabetic macular edema receiving intravitreal aflibercept

AURIGA is the largest prospective real-world study to evaluate intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion. This article presents 24-month data from the German cohort of treatment-naïve patients with DME. Treatment-naïve patients (≥ 18years) with DME were treated with IVT-AFL at the discretion of the physician in clinical practice. The primary endpoint was mean change in visual acuity (early treatment diabetic retinopathy, ETDRS, letters) at month12 compared to baseline. Statistical analyses were descriptive. The analysis included data from 150 DME patients (54.7% male). At months6, 12 and24, mean (95% confidence interval) visual acuity gains of4.6 (2.6; 6.5), 4.0 (2.1; 6.5) and 5.0 (3.0; 6.9) letters from baseline (mean ±SD: 65.0 ± 15.3 letters) and reductions in retinal thickness of 86µm (109; 64µm), 70µm (94; 43µm) and 75µm (103; 47µm) from baseline (mean ±SD: 391 ± 132 µm), respectively, were achieved. At month24, 54% of patients gained ≥ 5 letters and 22% ≥ 15 letters. Patients received amean number of 5.0 ± 1.6injections until month6, 7.1 ± 3.2 until month12 and9.0 ± 5.3 until month24, 68% of patients received ≥ 5injections until month6 and 56% ≥ 7injections within the first year. The safety profile was consistent with previous studies. In the German AURIGA cohort, treatment-naïve DME patients achieved aclinically relevant gain in visual acuity as well as reduction in central retinal thickness following IVT-AFL treatment in clinical practice. From month6 onwards, improvements were maintained despite alow injection frequency over 24months. In comparison with previous real-world studies, care of DME patients in clinical practice seems to have improved; however, there is still room for further improvement.

Factors Influencing Treatment Preference in Patients with Diabetic Macular Edema: A Study Using Conjoint Analysis.

Despite the wide range of treatment options available for diabetic macular edema (DME), adherence to treatment remains a barrier. Therefore, this study used conjoint analysis to examine the factors that patients with DME prioritize when choosing a course of treatment and investigated differences in quality of life and levels of disease self-management in patients with or without experience of anti-vascular endothelial growth factor (VEGF) treatment. A cross-sectional study was conducted through an online survey in Japan between May 31, 2022, and June 30, 2022. Questionnaires were sent to 27,236 individuals registered in the diabetes panels, with experience of treatment for DME within the last 10years. Conjoint analysis was employed to calculate the relative importance, i.e., degree of influence on patients' treatment choices, considering the trade-offs among five factors: cost per treatment, frequency of visits, anticipated post-treatment visual acuity, physician's explanation about disease and treatment, and frequency of treatment-related side effects. A total of 237 responses were used to assess the relative importance of cost per treatment, frequency of visits, anticipated post-treatment visual acuity, physician's explanation about the disease, treatment, and frequency of treatment-related side effects using conjoint analysis. The importance of each factor was anticipated post-treatment visual acuity at 30.0, frequency of treatment-related side effects at 25.5, treatment frequency at 17.7, cost per treatment at 16.5, and physician explanation about the disease and treatment at 10.4. The average EuroQoL 5 dimension 5 level index value in patients with and without anti-VEGF treatment experience was 0.785 and 0.825, respectively, with no major difference. Anticipated post-treatment visual acuity was identified as the most important factor in selecting a treatment regardless of the anti-vascular endothelial growth factor treatment experience demonstrating when patients with DME make treatment choices, anticipated post-treatment visual acuity is prioritized over treatment frequency and cost.

Bevacizumab First in DRCR Protocol AC vs Real-World Physician Treatment Choice for Diabetic Macular Edema: Two-Year Cost Analysis.

Purpose: To compare the modeled costs of the Protocol AC bevacizumab-first treatment protocol (with a switch to aflibercept for sub-responders) with real-world costs for treatment-naïve patients with diabetic macular edema (DME) over a 2-year period. Methods: Published data from the Diabetic Retinopathy Clinical Research Network (DRCR) Protocol AC bevacizumab-first arm (154 eyes) were used to model 2-year treatment costs. Real-world costs were modeled using data from the Vestrum Health electronic medical records database from a 2016 to 2018 cohort of treatment-naïve eyes with DME (n = 1062) treated with antivascular endothelial growth factor monotherapy. The visual acuity (VA) before treatment in the real-world cohort was matched to Protocol AC. A secondary cost analysis further matched VA gains after treatment in the real-world cohort (n = 346) to Protocol AC. Results: In Protocol AC, the modeled 2-year DME treatment cost in the bevacizumab-first arm was $18,952, with a mean of 16.1 injections over 22.5 visits and 70% of eyes being switched to aflibercept by year 2. (Within 2 years, 57% of injections were bevacizumab and 43% were aflibercept.) Over the same period, the modeled 2-year real-world cost ($11,459) was 40% lower, with a mean of 8.6 injections over 13.8 visits (42% bevacizumab, 45% aflibercept, 13% ranibizumab). Even when matched for baseline VA and a 14-letter VA gain over 2 years, the real-world cost ($15,394) was still 19% lower than the modeled cost in the Protocol AC bevacizumab-first arm. Conclusions: The real-world cost of treating DME over 2 years was significantly lower than the Protocol AC bevacizumab-first cost. Application of Protocol AC findings into real-world utilization, as with step therapy mandates, should only be considered if the same intensive protocol could be followed. These data suggest that existing real-world costs that reflect physician choice are already significantly lower than protocol-mandated step therapy, even when controlling for similar VA outcomes.

Sodium-glucose cotransporter 2 inhibitor therapy reduces the administration frequency of steroid injection in patients with diabetic macular edema: A cohort study using the Japanese health insurance claims database.

Severe diabetic macular edema (DME) is often resistant to anti-vascular endothelial growth factor therapy. Steroids are particularly effective at reducing edema by suppressing inflammation; they are also used as an alternative to expensive anti-vascular endothelial growth factor therapy in some patients. Therefore, the use of steroids in DME reflects an unmet need for anti-vascular endothelial growth factor therapy. Notably, triamcinolone acetonide (TA) injections are widely used in Japan. Here, we evaluated the frequency of TA as an indicator of the efficacy of sodium-glucose cotransporter 2 inhibitors (SGLT2is) in DME treatment using a health insurance claims database. In this cohort study, we retrospectively analyzed the health insurance claims data of 11 million Japanese individuals from 2005 to 2019. The frequency and duration of TA injection after the initiation of SGLT2is or other antidiabetic drugs were analyzed. Among the 2,412 matched patients with DME, the incidence rate of TA injection was 63.8 times per 1,000 person-years in SGLT2i users and 94.9 times per 1,000 person-years in non-users. SGLT2is reduced the risk for the first (P = 0.0024, hazard ratio 0.66, 95% confidence interval 0.50-0.87), second (P = 0.0019, hazard ratio 0.53, 95% confidence interval 0.35-0.80) and third TA (P = 0.0053, hazard ratio 0.44, 95% confidence interval 0.25-0.80) injections. A subanalysis of each baseline characteristic of the patients showed that SGLT2is were effective regardless of the background factors. The use of SGLT2is reduced the frequency of TA injection in patients with DME. Therefore, SGLT2i therapy might be a novel, noninvasive and low-cost adjunctive therapy for DME.

Caregiver Experience Survey of Anti-Vascular Endothelial Growth Factor Treatment for Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration

Introduction: Diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD) require frequent anti-vascular endothelial growth factor (VEGF) treatment and monitoring visits. We aimed to understand the burden of treatment on caregivers. Methods: This multinational, noninterventional study used a cross-sectional survey of adult patients with DME or nAMD treated with anti-VEGF injections in the USA, Canada, France, Italy, Spain, and the UK. The survey assessed caregivers’ sociodemographic characteristics, patient relationships, patients’ clinical history and treatment experiences, caregivers’ experiences, and the Caregiver Reaction Assessment of caregiving burden. Results: Caregivers for patients with DME (n = 30) and nAMD (n = 95) completed surveys. Mean ± standard deviation (SD) age was 64.0 ± 13.4 years, and most were female (71.2%), white (70.4%), married (66.4%), and from Europe (67.2%). Most were caring for their mother/father or partner/spouse (85.6%). Mean ± SD length of time as a caregiver was 9.1 ± 10.0 years. Caregivers estimated they provided support for 4.2 ± 2.9 days/week and 6.0 ± 7.1 h/day on average. Nearly half of caregivers (45.6%) reported some impairment in daily activities, and more than two-thirds (70.5%) of working caregivers (n = 44) reported work absenteeism due to anti-VEGF treatment/monitoring appointments. At least one treatment barrier was reported by 66.7% and 50.5% of caregivers of patients with DME and nAMD, respectively, which were related to coronavirus disease 2019- (38.4%), clinic- (18.4%), social-/health- (13.6%), treatment- (10.4%), or financial-related factors (4.8%). Caregiver Reaction Assessment scores indicated mild-to-moderate burden, with higher caregiver schedule disruption scores associated with an increasing number of anti-VEGF treatment/monitoring visits among DME caregivers (r = 0.61). Conclusion: Caregivers devote substantial time to caregiving, leading to schedule disruptions and absenteeism for some working caregivers. Positive and negative impacts on caregiver mental health were reported.

Real-World Efficacy of Intravitreal Faricimab for Diabetic Macular Edema: A Systematic Review.

Diabetic macular edema (DME) is a prevalent exudative maculopathy, and anti-vascular endothelial growth factor (anti-VEGF) therapy is the first-line choice for treatment. Faricimab, a novel anti-VEGF and anti-angiopoietin-2 bispecific agent, has recently been approved for the treatment of DME. In this study, we systematically reviewed the real-world evidence of the efficacy of faricimab for the treatment of DME. We searched 11 databases for eligible studies. Study selection and data extraction were made independently by two authors in duplicate. Eligible studies were reviewed qualitatively. We identified 10 eligible studies that summarized data from a total of 6054 eyes with a mean follow-up of between 55 days and 12 months. Five studies reported outcomes in a population of both treatment-naïve and previously treated eyes, and five studies reported outcomes exclusively in relation to eyes that were previously treated. Faricimab improved the best-corrected visual acuity and macular thickness. The extension of the treatment interval was possible in 61-81% of treatment-naïve eyes and 36-78% of previously treated eyes. Faricimab for DME yields clinical outcomes similar to those known from previous anti-VEGF treatments but with extended treatment intervals, thus lowering the burden of therapy for patients. Long-term real-world studies are warranted.