Management Of Diabetic Macular Edema Research Articles

Study of Imaging Biomarkers as a Prognostic Factor and Guide in the Management of Diabetic Macular Oedema

Study of Imaging Biomarkers as a Prognostic Factor and Guide in the Management of Diabetic Macular Oedema

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.

Evaluation of topical bromfenac as an adjunctive treatment with intravitreal ranibizumab in the management of diabetic macular edema

Background and purpose Intravitreal injection of anti- vascular endothelial growth factor medications has transformed the therapy of diabetic macular edema (DME). The purpose of this study was to evaluate the safety and efficacy of topical bromfenac as an adjunctive therapy to intravitreal ranibizumab injections in patients diagnosed with DME. Study design Prospective, randomized, controlled clinical trial. Patients The study included 40 eyes of patients with DME, divided into two groups: group I (20 eyes) received intravitreal ranibizumab injections and adjunctive topical bromfenac twice daily; group II (20 eyes) received only intravitreal ranibizumab injections. Methods All patients underwent assessments for best corrected visual acuity (BCVA), intraocular pressure, anterior segment, and fundus examination. Optical coherence tomography of the macula was repeated at 1, 3, and 6 months after the last injection. Results At 6 months, group I demonstrated significantly worse BCVA compared with group II (P=0.021). In group II, the 6-month change in central macular thickness from baseline was significantly greater in patients aged less than or equal to 60 years compared with those greater than 60 years (median = –170.5 μm vs. −40 μm, respectively; P=0.001) and in females compared with males (median = –75 μm vs. −23.4 μm; P=0.012). No significant differences were observed concerning the duration of diabetes (P=0.238), HbA1c levels (P=0.315), or laterality (P=0.792). Conclusion Topical bromfenac, when combined with intravitreal ranibizumab, showed some efficacy in the management of DME over a 6-month follow-up period, although the results were not statistically significant.

Efficacy and Safety of Fluocinolone Acetonide Implant in Diabetic Macular Edema: Practical Guidelines from Reference Center.

Diabetic macular edema (DME) is a common complication of diabetic retinopathy. Treatment with intravitreal injections is effective in most cases but is associated with a high therapeutic burden for patients. This implies the need for long-term treatments, such as the fluocinolone acetonide (FAc) implant. A review of basic science, pharmacology, and clinical data was conducted to provide a state-of-the-art view of the FAc implant in 2024. Although generally well tolerated, the FAc implant has been associated with ocular hypertension and cataract, and caution should be advised to the patients in this regard. By synthesizing information across these domains, a comprehensive evaluation can be attained, facilitating informed decision-making regarding the use of the FAc implant in the management of DME. The main objective of this review is to provide clinicians with guidelines on how to introduce and use the FAc implant in a patient with DME.

Anti-VEGF therapy for the long-term management of diabetic macular edema: a treat-to-target strategy based on macular morphology.

In an aging population, the prevalence and burden of diabetes mellitus, diabetic retinopathy, and vision-threatening diabetic macular edema (DME) are only expected to rise around the world. Similarly to other complications of diabetes mellitus, DME requires long-term management. This article aims to review the current challenges associated with the long-term management of DME, opportunities to improve outcomes for patients, and to develop a treat-to-target strategy based on macular morphology. At present, intravitreal anti-vascular endothelial growth factor (VEGF) therapy is the standard of care for the management of DME; however, best-achievable vision outcomes with treatment are reliant on frequent injections and close monitoring, which are difficult to maintain in current clinical practice because of the burden this imposes on patients. Achieving and maintaining good vision with treatment are the most important factors for patients with DME. Landmark trials have shown that vision gains with anti-VEGF therapy are typically accompanied by anatomical improvements (e.g., reductions in retinal thickness); therefore, multimodal imaging measures of macular morphology are often used in patients with DME to guide real-world treatment decisions. We would like to propose a hypothetical treat-to-target algorithm to guide physicians on treatment strategies for the long-term management of DME. Alternative measures of retinal fluid (e.g., persistence, stability, location) may be stronger predictors of visual acuity in DME, although further research is required to confirm whether alternate quantifiable biomarkers such as subretinal fluid and intraretinal fluid volumes can be used as a biomarker of clinical improvement. Identifying novel biomarkers and treatments that target neuroinflammation and neurodegeneration, improving patient-physician communication around treatment adherence, and using treat-to-target measures may help to ensure that the long-term benefits of treatment are realized.

Results of Intravitreal Injection of Bevacizumab before and with Phacoemulsification in Management of Diabetic Macular Edema in Cataractous Patients

Results of Intravitreal Injection of Bevacizumab before and with Phacoemulsification in Management of Diabetic Macular Edema in Cataractous Patients

Summary of Research: Cost‑Effectiveness of Faricimab in the Treatment of Diabetic Macular Oedema (DMO): A UK Analysis.

This is a summary of the original article ‟Cost‑Effectiveness of Faricimab in the Treatment of Diabetic Macular Oedema (DMO): A UK Analysis". DMO, a serious eye condition that can lead to vision loss in people with diabetes, is a significant health concern and a lack of knowledge exists about the cost-effectiveness (the balance of a treatment's cost and its effectiveness) of new treatments. This research assessed the cost-effectiveness of a new medication named faricimab, using a mathematical model that simulated the progression of DMO and its treatment over 25 years. The model compared faricimab against relevant therapeutic alternatives for DMO in the UK, including ranibizumab, aflibercept, and bevacizumab. The research discovered that faricimab could offer improved vision results and be cost saving or cost-effective. It also suggested that faricimab could lessen the strain on healthcare services due to its less frequent dosing schedule. Overall, such findings suggest that faricimab is a promising new treatment option for DMO that could benefit patients and the healthcare system. This could have implications for future treatment guidelines and the management of DMO in clinical practice.

Advancements in the Treatment of Diabetic Macular Edema: Current Strategies and Future Directions

This narrative review examines current and emerging treatment strategies for diabetic macular edema (DME), a complication of diabetic retinopathy characterised by fluid accumulation in the macula, which can lead to vision impairment. The incidence of DME is particularly high in patients with long-standing diabetes and advanced retinopathy. The current treatment options for DME include anti-vascular endothelial growth factor (anti-VEGF) agents, corticosteroids, and laser therapies. Anti-VEGF agents, including bevacizumab, ranibizumab, aflibercept, and the more recently developed brolucizumab and faricimab, have been demonstrated to reduce macular thickness and improve visual acuity. Brolucizumab offers the advantage of fewer injections due to its longer duration of action, although it carries a higher risk of ocular inflammation compared to other anti-VEGF agents. The dual inhibition of the VEGF and angiopoietin-2 (Ang-2) pathways by faricimab may enhance vascular stability and reduce inflammation, potentially improving patient outcomes. Steroid therapies, including dexamethasone, fluocinolone acetonide, and triamcinolone acetonide, represent an alternative for patients who do not respond adequately to anti-VEGF treatment. Laser therapies, including focal, navigated, and subthreshold laser treatments, remain a crucial component in the management of DME, with the ability to seal leaking vessels and reduce fluid accumulation. In order to achieve the best outcomes for patients, it is essential to continue to advance these treatment modalities and adopt a personalised, multifaceted approach.

Intravitreal OZURDEX vs. Intravitreal Bevacizumab for Diabetic Macular Edema: A Comprehensive Review.

This comprehensive review examines the efficacy, safety, and implications of intravitreal OZURDEX and intravitreal bevacizumab in treating diabetic macular edema (DME). DME is a common complication of diabetes mellitus and a leading cause of vision loss. OZURDEX, through sustained release of dexamethasone, targets inflammation and vascular permeability, while bevacizumab inhibits vascular endothelial growth factor (VEGF), reducing angiogenesis. However, differences in safety profiles exist, with OZURDEX associated with an increased risk of intraocular pressure elevation and cataract formation and bevacizumab potentially carrying systemic risks. The choice between these treatments should be individualized, considering patient preferences, ocular and systemic comorbidities, and cost-effectiveness. Collaboration among healthcare providers is essential for the comprehensive management of DME. Future research should focus on long-term comparative studies, predictors of treatment response, and exploration of novel therapeutic targets to optimize treatment outcomes for patients with DME.

Management of treatment-naïve diabetic macular edema patients: Review of real-world clinical data.

The high prevalence of Diabetic macular edema (DME) is a real global health problem. Its complex pathophysiology involves different pathways. Over the last decade, the introduction of intravitreal treatments has dramatically changed the management and prognosis of DME. Among the different treatment options, inhibitors of vascular endothelial growth factor (anti-VEGF) and intravitreal steroids implants represent the first-line therapy of DME. We conducted a review of electronic databases to compile the available evidence about the clinical management of DME in a clinical setting, with a special focus on treatment-naïve patients. Anti-VEGF therapies represent a valuable option for treating DME patients. However, many patients do not respond properly to this treatment and, due to its administration regimen, many patients receive suboptimal treatment in real life. Current evidence demonstrated that in patients with DME, DEX-i improved significantly both anatomic and visual outcomes. Besides eyes with insufficient anti-VEGF respond or recalcitrant DME cases, DEX-i can be effectively and safely used in treatment-naïve DME patients as first line therapy. DEX-i may be considered first line therapy in different clinical scenarios, such as DME eyes with a greater inflammatory component, patients with cardiovascular events, vitrectomized eyes, or those requiring cataract surgery. In conclusion, there are still many points for improvement pending in the clinical management of the patient with DME. Since DME treatment must follow a patient-tailored approach, selecting the best therapeutic approach for each patient requires a good understanding of the pathophysiology of DME.

Recommendations for diabetic macular edema management by retina specialists and large language model-based artificial intelligence platforms

PurposeTo study the role of artificial intelligence (AI) in developing diabetic macular edema (DME) management recommendations by creating and comparing responses to clinicians in hypothetical AI-generated case scenarios. The study also examined whether its joint recommendations followed national DME management guidelines.MethodsThe AI hypothetically generated 50 ocular case scenarios from 25 patients using keywords like age, gender, type, duration and control of diabetes, visual acuity, lens status, retinopathy stage, coexisting ocular and systemic co-morbidities, and DME-related retinal imaging findings. For DME and ocular co-morbidity management, we calculated inter-rater agreements (kappa analysis) separately for clinician responses, AI-platforms, and the “majority clinician response” (the maximum number of identical clinician responses) and “majority AI-platform” (the maximum number of identical AI responses). Treatment recommendations for various situations were compared to the Indian national guidelines.ResultsFor DME management, clinicians (ĸ=0.6), AI platforms (ĸ=0.58), and the ‘majority clinician response’ and ‘majority AI response’ (ĸ=0.69) had moderate to substantial inter-rate agreement. The study showed fair to substantial agreement for ocular co-morbidity management between clinicians (ĸ=0.8), AI platforms (ĸ=0.36), and the ‘majority clinician response’ and ‘majority AI response’ (ĸ=0.49). Many of the current study’s recommendations and national clinical guidelines agreed and disagreed. When treating center-involving DME with very good visual acuity, lattice degeneration, renal disease, anaemia, and a recent history of cardiovascular disease, there were clear disagreements.ConclusionFor the first time, this study recommends DME management using large language model-based generative AI. The study’s findings could guide in revising the global DME management guidelines.

The Treatment of Diabetic Retinal Edema with Intravitreal Steroids: How and When.

Diabetic macular edema (DME) is a common complication of diabetes mellitus and a leading cause of visual impairment worldwide. It is defined as the diabetes-related accumulation of fluid, proteins, and lipids, with retinal thickening, within the macular area. DME affects a significant proportion of individuals with diabetes, with the prevalence increasing with disease duration and severity. It is estimated that approximately 25-30% of diabetic patients will develop DME during their lifetime. Poor glycemic control, hypertension, hyperlipidemia, diabetes duration, and genetic predisposition are recognized as risk factors for the development and progression of DME. Although the exact pathophysiology is still not completely understood, it has been demonstrated that chronic hyperglycemia triggers a cascade of biochemical processes, including increased oxidative stress, inflammation, activation of vascular endothelial growth factor (VEGF), cellular dysfunction, and apoptosis, with breakdown of the blood-retinal barriers and fluid accumulation within the macular area. Early diagnosis and appropriate management of DME are crucial for improving visual outcomes. Although the control of systemic risk factors still remains the most important strategy in DME treatment, intravitreal pharmacotherapy with anti-VEGF molecules or steroids is currently considered the first-line approach in DME patients, whereas macular laser photocoagulation and pars plana vitrectomy may be useful in selected cases. Available intravitreal steroids, including triamcinolone acetonide injections and dexamethasone and fluocinolone acetonide implants, exert their therapeutic effect by reducing inflammation, inhibiting VEGF expression, stabilizing the blood-retinal barrier and thus reducing vascular permeability. They have been demonstrated to be effective in reducing macular edema and improving visual outcomes in DME patients but are associated with a high risk of intraocular pressure elevation and cataract development, so their use requires an accurate patient selection. This manuscript aims to provide a comprehensive overview of the pathology, epidemiology, risk factors, physiopathology, clinical features, treatment mechanisms of actions, treatment options, prognosis, and ongoing clinical studies related to the treatment of DME, with particular consideration of intravitreal steroids therapy.

Innovations in Diabetic Macular Edema Management: A Comprehensive Review of Automated Quantification and Anti-vascular Endothelial Growth Factor Intervention.

Diabetic macular edema (DME) poses a significant threat to the vision and quality of life of individuals with diabetes. This comprehensive review explores recent advancements in DME management, focusing on integrating automated quantification techniques and anti-vascular endothelial growth factor (anti-VEGF) interventions. The review begins with an overview of DME, emphasizing its prevalence, impact on diabetic patients, and current challenges in management. It then delves into the potential of automated quantification, leveraging machine learning and artificial intelligence to improve early detection and monitoring. Concurrently, the role of anti-VEGF therapies in addressing the underlying vascular abnormalities in DME is scrutinized. The review synthesizes vital findings, highlighting the implications for the future of DME management. Promising outcomes from recent clinical trials and case studies are discussed, providing insights into the evolving landscape of personalized medicine approaches. The conclusion underscores the transformative potential of these innovations, calling for continued research, collaboration, and integration of these advancements into clinical practice. This review aims to serve as a roadmap for researchers, clinicians, and industry stakeholders, fostering a collective effort to enhance the precision and efficacy of DME management.

Diabetic Macular Edema Management: A Review of Anti-Vascular Endothelial Growth Factor (VEGF) Therapies.

Diabetic macular edema (DME) is a major cause of vision impairment in diabetic individuals, characterized by fluid accumulation in the macula due to a breakdown of the blood-retinal barrier (BRB). This review article explores the role of anti-vascular endothelial growth factor (anti-VEGF) therapies in the management of DME. Anti-VEGF treatments, including ranibizumab, bevacizumab, and aflibercept, have revolutionized DME management by targeting VEGF, a key mediator in DME pathogenesis. We critically examined the efficacy of these therapies in reducing macular edema and improving visual acuity, assessed their safety and tolerability, and explored the variability in treatment response. The review highlights the latest advancements and future directions in anti-VEGF therapy, including novel drug delivery systems and emerging treatment paradigms. By providing a comprehensive overview of current anti-VEGF therapies, this review seeks to inform clinical practice, guide future research, and contribute to improved patient outcomes in DME management.

Optical Coherence Tomography-Based Grading of Diabetic Macular Edema Is Associated with Systemic Inflammatory Indices and Imaging Biomarkers

Introduction: Objectives of the study were to investigate the correlation between optical coherence tomography (OCT)-based grading of diabetic macular edema (DME) and systemic inflammatory indices, imaging biomarkers, and early anti-vascular endothelial growth factor (VEGF) treatment response. Methods: A total of 111 eyes from 111 patients with DME treated with intravitreous anti-VEGF therapy for 3 consecutive months every month were enrolled in this retrospective study. According to a protocol termed “TCED,” DME was divided into early, advanced, severe, and atrophic stages. The best-corrected visual acuity (BCVA), subretinal fluid (SRF), and the number of hyperreflective foci (HRF) in the whole retinal layers were analyzed at baseline and 3 months after the first injection. Peripheral blood inflammatory indices were calculated, including neutrophil-to-lymphocyte ratio (NLR), monocyte-to-lymphocyte ratio (MLR), platelet (PLT)-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), and C-reactive protein (CRP). Statistical analysis was performed to compare the visual and anatomical results and evaluate HRF and SRF in different stages of DME before and after treatment. Results: There were significant differences in systemic inflammatory indices among the four groups, including NLR, PLR, MLR, SII, and CRP (all p < 0.05). The CRP, NLR, PLR, MLR, and SII were significantly higher in the atrophic stage compared to the advanced stage (all p < 0.05). Conversely, the CRP, NLR, PLR, MLR, and SII were significantly lower in the advanced stage compared to the early stage (all p < 0.05). Except for the atrophic stage, BCVA and central retinal thickness (CRT) were significantly improved after treatment in early, advanced and severe stages (all p < 0.05), especially in the severe stage. The decline in the proportion of SRF and HRF ≥20 was the most significant in the advanced stage after anti-VEGF treatment (p < 0.001, p = 0.016), but not in the early and severe stages (all p > 0.05). Conclusion: Systemic inflammatory indices and the decline in the proportion of SRF and HRF ≥20 were closely associated with different stages of DME based on “TCED.” Meanwhile, the “TCED” grading system can predict visual and anatomical prognosis of DME after anti-VEGF treatment, which may be a biomarker for identifying risk stratification and management of DME.

Serum microRNAs as biomarkers associated with the course of diabetic macular oedema

Aims/Purpose: Intravitreal drugs are powerful therapies for diabetic macular edema (DME), but the clinical course and the response to treatments still remains unpredictable. MicroRNAs (miRNAs) represent a class of small molecules associated with the regulation of several metabolic pathways, including diabetes. However, their use in the clinical setting of DME is limited by lack of data regarding the correlation with clinical and imaging features. In the present study we evaluated some miRNAs profiles obtained by serum samples of newly diagnosed DME patients.Methods: Prospective study, including baseline visit (V0), a 4‐months visit (V1) and a 12‐months visit (V2). At V0 patient underwent serum sampling, imaging was repeated at every study visit. Enriched serum microRNAs were extracted and real‐time PCR was performed. OCT features were used to assess the severity and progression of the disease.Results: We collected data of a cohort of type 1 and type 2 diabetic patients. All the patients presented DME and were naïve to intravitreal treatments. The follow‐up was of 12 months. Diabetes‐related miRNAs were found up‐ or downregulated and associated with the course of DME (resolved/recurrent/persistent). Correlations were found with imaging biomarkers.Conclusions: On the basis of these findings, serum miRNAs assessment is a feasible and clinically relevant assessment to be performed in the diagnostic work‐up of diabetic patients affected by DME. MiRNAs might pave the basis for customized treatment strategies to optimize the management of DME.

Comparative Analysis of Intravitreal Dexamethasone Implant (Ozurdex) and Brolucizumab Injection in the Treatment of Diabetic Macular Edema with Hyperreflective Intraretinal Dots: A Retrospective Study.

This retrospective study aimed to compare the efficacy and safety of intravitreal Dexamethasone Implant (DEX) and Brolucizumab Injection in treating Diabetic Macular Edema (DME) with Hyperreflective Intraretinal Dots (HRID). A single-center retrospective study in India included 40 eyes (20 per group) with controlled diabetes and HRID on optical coherence tomography. Patients received either DEX or Brolucizumab, with outcomes assessed at various intervals up to 24weeks. Primary measures included Best-Corrected Visual Acuity (BCVA), Central Macular Thickness (CMT), and safety parameters. Both treatment groups demonstrated comparable baseline characteristics. Both treatments significantly improved the BCVA at weeks 4, 12, and 24, with the DEX implant showing significantly better results at week 12 than brolucizumab (P=0.04). In treatment-naïve eyes, BCVA improvements were similar across all time points. In recalcitrant DME eyes, DEX showed significant BCVA improvements at all time points, while brolucizumab showed significant improvements only at weeks 4 (P=0.005) and 24 (P=0.04). The CMT also improved with both treatments, with DEX showing superior reduction at weeks 4 (P=0.003), 12 (P=0.003), and 24 (P=0.002) respectively. In treatment-naïve eyes, DEX showed consistently better CMT reductions. In refractory DME eyes, both treatments significantly reduced CMT, with DEX performing better at week 12 (P=0.042). DEX required fewer injections (DEX: 1.5±0.61; brolucizumab: 2.4±0.82; P=0.0002) and less supplementary laser treatment (DEX:8/20, 40% eyes; brolucizumab: 16/20, 80%; P=0.01) compared to brolucizumab. No adverse events were observed in either group. The study suggests the potential superiority of intravitreal DEX implant over brolucizumab in managing DME with HRID. DEX exhibited sustained positive responses in BCVA and CMT, requiring fewer injections and supplementary interventions. Future research should explore extended follow-up durations, personalized treatment strategies, and refined biomarkers to optimize DME management.

Effects of repeated intravitreal bevacizumab administration on anterior segment parameters and limbal stem cells

Background: Macular edema (ME) is fluid accumulation in the macula caused by vascular leakage. Repeated intravitreal bevacizumab (IVB) injections are extensively used to treat ME of different origins, are well tolerated, and have few side effects. This study evaluated the effects of repeated IVB injections on the anterior segment parameters and limbal stem cells (LSCs) in eyes with ME.&#x0D; Methods: This before–after study involved patients with ME of different causes who underwent repeated IVB injections at the Imam Khomeini Ophthalmology Center in Kermanshah, Iran. Before and after repeated IVB injections, anterior segment parameters were measured using anterior segment optical coherence tomography, and the LSCs were assessed using impression cytology.&#x0D; Results: We enrolled 42 eyes of 42 patients with a mean (standard deviation [SD]) age of 59.6 (7.6) years, of whom 25 (59.5%) were men and 17 (40.5%) were women. The underlying diseases included diabetic ME in 30 eyes (71.4%), central (5 [11.9%]) or branch (3 [7.1%]) retinal vein occlusion, and choroidal neovascularization in 4 eyes (9.5%). The right eye was affected in 22 (52.4%) participants. The mean (SD) number of IVB injections was 4.3 (1.3). After repeated injections, the mean central corneal thickness (CCT) increased, whereas the mean anterior chamber angle (ACA) and anterior chamber depth (ACD) decreased (all P&lt;0.001). Three patients developed LSC deficiency after repeated IVB injections for diabetic ME.&#x0D; Conclusions: We observed a significant increase in the mean CCT and a decrease in the mean ACA and ACD after repeated IVB injections in our series. Three patients developed LSC deficiency after repeated IVB injections for diabetic ME management. The observed effect on LSC may cast doubt on the safety of repeated IVB injections; however, this finding must be verified in multicenter clinical trials with longer follow-up periods and larger study samples.

RWC Update: Macular Indentation to Manage Complications of Pathological Myopia; OCT Biomarker Based Decision Making in the Management of Diabetic Macular Edema; Scleritis With Chorioretinal Folds.

RWC Update: Macular Indentation to Manage Complications of Pathological Myopia; OCT Biomarker Based Decision Making in the Management of Diabetic Macular Edema; Scleritis With Chorioretinal Folds.

From randomised controlled trials to real-world data: Clinical evidence to guide management of diabetic macular oedema.

Randomised clinical trials (RCTs) are generally considered the gold-standard for providing scientific evidence for treatments' effectiveness and safety but their findings may not always be generalisable to the broader population treated in routine clinical practice. RCTs include highly selected patient populations that fit specific inclusion and exclusion criteria. Although they may have a lower level of certainty than RCTs on the evidence hierarchy, real-world data (RWD), such as observational studies, registries and databases, provide real-world evidence (RWE) that can complement RCTs. For example, RWE may help satisfy requirements for a new indication of an already approved drug and help us better understand long-term treatment effectiveness, safety and patterns of use in clinical practice. Many countries have set up registries, observational studies and databases containing information on patients with retinal diseases, such as diabetic macular oedema (DMO). These DMO RWD have produced significant clinical evidence in the past decade that has changed the management of DMO. RWD and medico-administrative databases are a useful resource to identify low frequency safety signals. They often have long-term follow-up with a large number of patients and minimal exclusion criteria. We will discuss improvements in healthcare information exchange technologies, such as blockchain technology and FHIR (Fast Healthcare Interoperability Resources), which will connect and extend databases already available. These registries can be linked with existing or emerging retinal imaging modalities using artificial intelligence to aid diagnosis, treatment decisions and provide prognostic information. The results of RCTs and RWE are combined to provide evidence-based guidelines.