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New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel.

ABSTRACT: The current standard therapy for patients with diabetic macular oedema (DME)--focal/grid laser photocoagulation--usually does not improve impaired vision, and many patients lose vision despite laser therapy. Recent approval of ranibizumab by the European Medicines Agency to treat visual impairment due to DME fulfils the previously unmet medical need for a treatment that can improve visual acuity (VA) in these patients. We reviewed 1- and 2-year clinical trial findings for ranibizumab used as treatment for DME to formulate evidence-based treatment recommendations in the context of this new therapy. DME with or without visual impairment should be considered for treatment when it fulfils the Early Treatment Diabetic Retinopathy Study (ETDRS) criteria for clinically significant oedema. For DME with centre involvement and associated vision loss due to DME, monthly ranibizumab monotherapy with treatment interruption and re-initiation based on VA stability is recommended. Laser therapy based on ETDRS guidelines is recommended for other forms of clinically significant DME without centre involvement or when no vision loss has occurred, despite centre involvement. Because these recommendations are based on randomised controlled trials of 1-2 years duration, guidance may need updating as long-term ranibizumab data become available and as additional therapeutic agents are assessed in clinical trials.

SUBMITTER: Bandello F

PROVIDER: S-EPMC3325561 | biostudies-other | 2012 Apr

REPOSITORIES: biostudies-other

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Translating evidence into practice: recommendations by a UK expert panel on the use of aflibercept in diabetic macular oedema.

Project description:OBJECTIVES:This paper describes recommendations from a panel of UK retina experts on aflibercept in diabetic macular oedema (DMO). METHODS:A roundtable meeting was held in London, UK in March 2018. The meeting was sponsored by Bayer. RESULTS:Recommendations are based on clinical experience and level 1 evidence. Clinical experience supports the evidence base, reinforcing that aflibercept should be initiated with intensive proactive dosing at 2?mg every 4 weeks. Most panel members use six initial 4-weekly doses as in Protocol T, rather than five initial monthly doses as recommended in the Summary of product characteristics (SmPC). After intensive proactive dosing, patients with a good response (meet Protocol T 'improvement' criteria ?5-letter improvement in visual acuity [VA] and/or ?10% improvement in central subfield thickness [CST] from baseline) but who are not yet stable should continue with 4-weekly aflibercept until stability is reached. Patients with a good response and stability should initiate monitor-and-extend (not in line with SmPC). Those with a sub-optimal response (meet 'improvement' criteria but with additional concerns e.g. fluid worsening on macular volume map) should continue with 4-weekly aflibercept but additional treatments should be considered (aflibercept is not licensed for combination treatment). For patients with no response (no change, or meeting Protocol T 'worsening' criteria [?5-letter decrease in VA and/or???10% increase in CST] from baseline), switching to a non-anti-vascular endothelial growth factor treatment should be considered. CONCLUSIONS:Clinical experience reinforces that, when using aflibercept in DMO, the licensed posology or Protocol T regimens achieve the best outcomes.

| S-EPMC7182551 | biostudies-literature

The management of diabetic macular oedema.

Project description:Diabetic macular oedema (DMO) is a significant cause of visual loss in the working population. Focal/grid photocoagulation remains an effective treatment for DMO and the benchmark to which clinicians compare other newer treatment modalities. There are, however, patients who do not respond adequately or who are refractory to laser photocoagulation. This has led to the development of newer treatments such as the intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors as well as intravitreal corticosteroid releasing delivery systems. Cataract formation and raised intraocular pressure remain the major disadvantages of corticosteroid use. There is mounting evidence that intravitreal VEGF inhibitors with or without combined laser photocoagulation will become the gold standard treatment for DMO.

| S-EPMC3729702 | biostudies-literature

Rho-Kinase Inhibitors for the Treatment of Refractory Diabetic Macular Oedema.

Project description:Diabetic macular oedema (DMO) is one of the leading causes of vision loss associated with diabetic retinopathy (DR). New insights in managing this condition have changed the paradigm in its treatment, with intravitreal injections of antivascular endothelial growth factor (anti-VEGF) having become the standard therapy for DMO worldwide. However, there is no single standard therapy for all patients DMO refractory to anti-VEGF treatment; thus, further investigation is still needed. The key obstacles in developing suitable therapeutics for refractory DMO lie in its complex pathophysiology; therefore, there is an opportunity for further improvements in the progress and applications of new drugs. Previous studies have indicated that Rho-associated kinase (Rho-kinase/ROCK) is an essential molecule in the pathogenesis of DMO. This is why the Rho/ROCK signalling pathway has been proposed as a possible target for new treatments. The present review focuses on the recent progress on the possible role of ROCK and its therapeutic potential in DMO. A systematic literature search was performed, covering the years 1991 to 2021, using the following keywords: "rho-Associated Kinas-es", "Diabetic Retinopathy", "Macular Edema", "Ripasudil", "Fasudil" and "Netarsudil". Better insight into the pathological role of Rho-kinase/ROCK may lead to the development of new strategies for refractory DMO treatment and prevention.

| S-EPMC8307715 | biostudies-literature

Monotherapy laser photocoagulation for diabetic macular oedema.

Project description: Not available

| S-EPMC6516994 | biostudies-literature

Microperimetry and mfERG as functional measurements in diabetic macular oedema undergoing intravitreal ranibizumab treatment.

Project description:PurposeTo evaluate Microperimetry (MP) and multifocal electroretinogram (mfERG) as whole-macula functional markers of treatment response in naive diabetic macular oedema (DMO) patients undergoing ranibizumab treatment.MethodsAn exploratory sub-analysis of a prospective study (NCT01947881-CHARTRES). Patients received three monthly ranibizumab injections (loading dose) followed by pro re nata (PRN) regimen during 1 year. At baseline, during and after treatment (Months 0, 3, 6 and 12), subjects were tested using BCVA, OCT, MP and mfERG. MP was performed in the central 12°, and retinal sensitivity was measured overall (mean sensitivity (MS)), and in three concentric rings (R1-R3). mfERG P1 amplitude and implicit time were measured over six concentric rings (R1-R6).ResultsThirty-two eyes were included. MP mean and rings sensitivity were significantly lower in DMO (p < 0.001). After loading dose, a significant improvement in retina sensitivity was observed, particularly in good BCVA responders (MS = +2.28 dB; R1 = +2.33 dB, R2 = +2.20 dB, R3 = +2.25 dB; p = 0.049). Overall retinal sensitivity was significantly correlated with BCVA improvement (r = 0.54; p = 0.026) and inversely correlated with OCT central subfield thickness improvement (r = -0.39; p = 0.026). mfERG amplitude and implicit time were also lower in DMO (p < 0.011). An improvement of mfERG P1 amplitude and implicit time in R1 was noted in good responders after ranibizumab loading dose (+16.49 nV/deg2; p = 0.013 and -0.005 ms; p = 0.048, respectively). When changing to PRN treatment regimen, BCVA was maintained during the 12 months of follow-up but worsening of the visual function was detected by MP and mfERG.ConclusionsMicroperimetry and mfERG were able to demonstrate DMO functional improvement after treatment loading dose, as well as early visual changes when treatment regimen was switched to PRN.

| S-EPMC8182789 | biostudies-literature

Levosulpiride for the treatment of diabetic macular oedema: a phase 2 randomized clinical trial.

Project description:Background/objectiveThe prokinetic levosulpiride elevates vasoinhibin levels in the vitreous of patients with proliferative diabetic retinopathy (PDR) suggesting clinical benefits due to the anti-vasopermeability and anti-angiogenic properties of vasoinhibin. We investigated the biological activity of levosulpiride in centre-involving diabetic macular oedema (DME).Patients/methodsProspective, randomized, double-blinded, dual-centre, phase 2 trial in patients with centre-involving DME orally treated with placebo (n = 17) or levosulpiride (n = 17) for 8 weeks or in patients with PDR undergoing elective pars plana vitrectomy and receiving placebo (n = 18) or levosulpiride (n = 18) orally for the 1 week before vitrectomy.ResultsLevosulpiride improved changes from baseline in best-corrected visual acuity (p ≤ 0.037), central foveal thickness (CFT, p ≤ 0.013), and mean macular volume (MMV, p ≤ 0.002) at weeks 4, 6, and 8 compared to placebo. At 8 weeks, the proportion of eyes gaining ≥5 ETDRS letters at 4 m (41% vs. 28%), losing ≥21 μm in CFT (55% vs. 28%), and dropping ≥0.06 mm3 in MMV (65% vs. 29%) was higher after levosulpiride than placebo. The overall grading of visual and structural parameters improved with levosulpiride (p = 0.029). Levosulpiride reduced VEGF (p = 0.025) and PlGF (p = 0.008) levels in the vitreous of PDR patients. No significant adverse side-effects were detected.ConclusionsOral levosulpiride for 8 weeks improved visual and structural outcomes in patients with centre-involving DME by mechanisms that may include intraocular upregulation of vasoinhibin and downregulation of VEGF and PlGF. Larger clinical trials evaluating long-term efficacy and safety are warranted.

| S-EPMC10858020 | biostudies-literature

Evidence underlying the clinical management of diabetic macular oedema.

Project description:Diabetic retinopathy (DR) is the leading cause of visual loss in the developed world in those of working age, and its prevalence is predicted to double by 2025. The management of diabetic retinopathy has traditionally relied on screening, on laser treatment delivered by ophthalmologists, and on optimising blood glucose and blood pressure. Recent evidence suggests that the role of systemic factors is more complex than originally thought, and that drugs such as ACE inhibitors, fibrates and glitazones may all influence the course of diabetic macular oedema. Antagonism of vascular endothelial growth factor offers a new therapeutic avenue that may transform the management of diabetic macular oedema. Several other therapeutic options are under investigation and development, including aminoguanidine, sorbinol, ruboxistaurin and autologous stem cell transfusion.

| S-EPMC4954300 | biostudies-literature

Aflibercept versus ranibizumab for treating persistent diabetic macular oedema.

Project description:The purpose of this study was to compare the efficacy of intravitreal aflibercept versus ranibizumab for treating therapy-resistant diabetic macular oedema (DME). A 69-year-old man presented with persistent bilateral DME despite previous ranibizumab treatment. Bilateral study treatment comprised one cycle of three monthly ranibizumab injections (0.5 mg), followed by one cycle of three aflibercept injections (2.0 mg), a second ranibizumab cycle and a second aflibercept cycle. Baseline visual acuity (ETDRS score) was 60 letters for the right eye and 65 letters for the left eye. Baseline central foveal thickness (CFT) was 305 ?m for the right eye and 453 ?m for the left eye. Substantially improved outcomes were observed during the first aflibercept cycle. CFT was reduced by 150 ?m (mean) in both the eyes and decreased below the lowest level achieved during the previous 2.5-year ranibizumab treatment. Visual acuity was improved by 17.5 letters (mean) in both the eyes. Reintroduction of ranibizumab immediately worsened the status of both eyes back to the baseline level. During the final aflibercept cycle, visual acuity and CFT improved to the same levels achieved during the first aflibercept cycle. In this case study, we prospectively switched the treatment three times and observed a dramatic and consistent treatment advantage for aflibercept.

| S-EPMC4488481 | biostudies-literature

A noninterventional study to monitor patients with diabetic macular oedema starting treatment with ranibizumab (POLARIS).

Project description:PurposeAntivascular endothelial growth factor agents are increasingly used in diabetic macular oedema (DME); however, there are few studies exploring their use in DME in real-world settings.MethodsPOLARIS was a noninterventional, multicentre study to monitor 12-month outcomes in patients starting ranibizumab treatment in routine practices. The primary outcome was mean change in visual acuity (VA) from baseline to month 12 (last observation carried forward approach). Other outcomes included mean change in central retinal thickness (CRT) and resource utilization. Visual acuity (VA) outcomes were also stratified by country, baseline visual acuity score (VAS), sex, age and injection frequency.ResultsOutcomes were analysed from all treated patients (n = 804) and from first-year completers (patients who had a visual acuity assessment at 12 months; n = 568). The mean (SD) baseline VAS was 59.4 (15.9) letters, and the mean change in visual acuity was 4.4 letters (95% confidence interval: 3.3-5.4) at month 12 (study eye; first-year completers). The mean number of injections (study eye) was 4.9, and the mean number of all visits (any eye) was 10 (58% were injection visits) over 12 months (first-year completers). The mean (SD) baseline CRT was 410.6 (128.8) μm, and the mean change in CRT was -115.2 μm at month 12 (study eye; first-year completers). Visual acuity (VA) outcomes were generally comparable across most countries and subgroups and were greatest in patients with the lowest baseline VAS (≤60 letters).ConclusionPOLARIS showed that real-world outcomes in DME patients starting treatment with ranibizumab were lower than those observed in clinical studies, in spite of extensive monitoring.

| S-EPMC6585847 | biostudies-literature

Retrospective Analysis of Treatment Patterns in Pseudophakic Diabetic Macular Oedema Eyes Treated with Anti-VEGF.

Project description:MethodsWe performed a retrospective review of outcomes in 81 pseudophakic eyes with DMO that received at least 6 anti-VEGF injections. We reviewed baseline and posttreatment optical coherence tomography images, visual acuity, prescribing patterns, time taken to deliver anti-VEGF injections, and structural and functional outcomes.ResultsIt took an average of 913 ± 454.1 days to deliver a mean of 11.1 ± 4.7 anti-VEGF injections. Time from baseline to receiving the first 6 anti-VEGF injections was longer than 9 months in 74.7% (n = 59/79) of eyes. There was a mean gain of 1.6 letters (-0.03 logMAR) from baseline to the end point. After 5 anti-VEGF intravitreal injections, the mean CMT was 391.9 μm from 474.4 μm at baseline (p < 0.0001). In 52 of 79 eyes (65.8%), more than one type of anti-VEGF agent was used.ConclusionsThe anti-VEGF treatment used to treat these eyes with DMO was suboptimal, a finding consistent with recently published "real-world" data. There was a strong tendency for patients to be switched within the class to a second anti-VEGF agent.

| S-EPMC8337101 | biostudies-literature

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