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Add-on effect of Qiming granule, a Chinese patent medicine, in treating diabetic macular edema: A systematic review and meta-analysis.
Hu, Z, Xie, C, Yang, M, Fu, X, Gao, H, Liu, Y, Xie, H
Phytotherapy research : PTR. 2021;(2):587-602
Abstract
This study aims to evaluate the efficacy and safety of Qiming granule (QG) on diabetic macular edema (DME). PubMed, Embase, the Cochrane Library, CNKI, Wanfang, qvip and China Biology Medicine Disc were searched. Randomized controlled trials (RCTs) about participants with a diagnosis of DME were included. Risk of bias assessment was conducted by Cochrane risk-of-bias tool for RCT. Random-effects model was implemented to pool results. Among 16 included studies, QG combined with conventional treatment was administered 13.5 g daily for a period ranging from 2 to 6 months. Results showed combination therapy was more effective than conventional treatment alone in central macular thickness (weighted mean difference (WMD) = -29.43, 95% confidence interval (CI) (-39.56 to -19.29), p = .0001), optimum corrected vision (pooled standardized mean difference (SMD) = -0.962, 95%CI (-1.35 to -0.57), p = .0001) and overall effective rate (RR = 1.25, 95%CI = [1.13 to 1.35], p < .0001). Only three studies reported adverse effects. The quality of evidence is low. Due to a lack of placebo control, the net efficacy of QG is still uncertain. More high-quality RCTs are needed to confirm the efficacy and safety of QG in DME.
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Intravitreal bevacizumab versus intravitreal triamcinolone for diabetic macular edema-Systematic review, meta-analysis and meta-regression.
Abdel-Maboud, M, Menshawy, E, Bahbah, EI, Outani, O, Menshawy, A
PloS one. 2021;(1):e0245010
Abstract
BACKGROUND The most frequent cause of vision loss from diabetic retinopathy is diabetic macular edema (DME). Earlier clinical trials tried to examine the role of intravitreal triamcinolone (IVT) and intravitreal bevacizumab (IVB) in DME; they either qualified IVT over IVB or IVB over IVT or did not exhibit a significant difference. OBJECTIVE This paper aims to compare the efficacy and safety of IVB versus IVT alone or combined IVB+IVT in the treatment of DME. METHODS We systematically searched PubMed, CENTRAL, Scopus, Embase, Science Direct, OVID, and Web of Science for randomized controlled trials of IVB versus IVT alone or combined IVB+IVT and IVT versus the combined IVB+IVT in DME patients. RESULTS A total of 1243 eyes of 17 trials were included in our meta-analysis and regression. Repeated injections of IVB were superior at improving VA comparing with those of IVT at 12, 24, 48-weeks, and IVB+IVT at 12, 24, 48-weeks. Single injections were comparable across the three arms regarding BCVA improvement. CMT reductions were also comparable across the three arms. Meanwhile, the overall safety regarding intraocular pressure and intraocular hypertension significantly favored the IVB group. Improvement in VA was best modified with CMT reduction from 480 um to 320um. This association was significant at 12-weeks in the three arms and persisted till 24-weeks and 48-weeks exclusively in the IVB group. CONCLUSIONS AND RELEVANCE Our analysis reveals that repeated successive injections associate with better BCVA compared to single injection. Current evidence affirms that IVB is superior to IVT and IVB+IVT at improving BCVA, comparable at reducing CMT, and presents a better safety profile in the treatment of DME.
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Fluocinolone acetonide vitreous insert for chronic diabetic macular oedema: a systematic review with meta-analysis of real-world experience.
Fallico, M, Maugeri, A, Lotery, A, Longo, A, Bonfiglio, V, Russo, A, Avitabile, T, Furino, C, Cennamo, G, Barchitta, M, et al
Scientific reports. 2021;(1):4800
Abstract
We conducted a meta-analysis of real-world studies on the 0.19 mg Fluocinolone Acetonide (FAc) intravitreal implant for chronic diabetic macular oedema (DMO), comparing these findings with the Fluocinolone Acetonide for Diabetic Macular Edema (FAME) study. The primary outcome was mean change of best corrected visual acuity (BCVA) at 24 months. Secondary outcomes were 36-month mean BCVA, mean central macular thickness (CMT) change, rates of eyes receiving supplementary intravitreal therapy, cataract surgery, intraocular pressure (IOP)-lowering drops and glaucoma surgery. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Nine real-world studies were included. The FAc implant yielded a significantly improved BCVA at 24 and 36 months (24-month MD = 4.52; 95% CI 2.56-6.48; 36-month MD = 8.10; 95% CI 6.34-9.86). These findings were comparable with the FAME study. The FAc implant yielded significantly reduced 24- and 36-month CMT. Pooled proportions of cataract surgery, IOP-lowering drops and glaucoma surgery were 39%, 27% and 3%, respectively, all lower than the FAME study. Pooled estimate of supplementary intravitreal therapy was 39%, higher than the 15.2% of the FAME study. This meta-analysis of real-world studies confirms favorable visual and anatomical outcomes following FAc insert for chronic DMO. In real-life studies more than one third of patients received supplementary intravitreal therapy, an issue that needs to be further explored.
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Prevalence, incidence and future projection of diabetic eye disease in Europe: a systematic review and meta-analysis.
Li, JQ, Welchowski, T, Schmid, M, Letow, J, Wolpers, C, Pascual-Camps, I, Holz, FG, Finger, RP
European journal of epidemiology. 2020;(1):11-23
Abstract
To examine the prevalence and incidence of diabetic eye disease (DED) among individuals with diabetes in Europe, a systematic review to identify all published European prevalence and incidence studies of DED in individuals with diabetes managed in primary health care was performed according to the MOOSE and PRISMA guidelines. The databases Medline, Embase and Web of Science were searched to 2 September 2017. Meta-analyses and meta-regressions were performed. The pooled prevalence estimates were applied to diabetes prevalence rates provided by the International Diabetes Foundation atlas and Eurostat population data, and extrapolated to the year 2050. Data of 35 prevalence and four incidence studies were meta-analyzed. Any diabetic retinopathy (DR) and diabetic macular edema (DME) were prevalent in 25.7% (95% CI 22.8-28.8%) and 3.7% (95% CI 2.2-6.2%), respectively. In meta-regression, the prevalence of DR in persons with type 1 diabetes was significantly higher compared to persons with type 2 diabetes (54.4% vs. 25.0%). The pooled mean annual incidence of any DR and DME in in persons with type 2 diabetes was 4.6% (95% CI 2.3-8.8%) and 0.4% (95% CI 0.5-1.4%), respectively. We estimated that persons with diabetes affected by any DED in Europe will increase from 6.4 million today to 8.6 million in 2050, of whom 30% require close monitoring and/or treatment. DED is estimated to be present in more than a quarter of persons with type 2 diabetes and half of persons with type 1 diabetes underlining the importance of regular monitoring. Future health services need to be planned accordingly.
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Cost-effectiveness and diagnostic accuracy of telemedicine in macular disease and diabetic retinopathy: A systematic review and meta-analysis.
Ullah, W, Pathan, SK, Panchal, A, Anandan, S, Saleem, K, Sattar, Y, Ahmad, E, Mukhtar, M, Nawaz, H
Medicine. 2020;(25):e20306
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Abstract
OBJECTIVE To determine cost-effectiveness and the diagnostic accuracy of teleophthalmology (TO) in the detection of macular edema (ME) and various grades of diabetic retinopathy (DR). METHODS MEDLINE, EMBASE, and Cochrane databases were searched for TO, ME, and DR on May 25, 2016. The search was updated on April 2, 2019. Pooled sensitivity and specificity for ME and various grades of DR were determined using Meta-Disc software. A systematic review of the articles discussing the cost-effectiveness of TO screening was also performed. RESULTS Thirty-three articles on the diagnostic accuracy and 28 articles on the cost-effectiveness were selected. CONCLUSIONS Telescreening is moderately sensitive but very specific for the diagnosis of diabetic retinopathy. Non-mydriatic Teleretinal screening services are cost-effective, decrease clinics workload, and increase patient compliance if provided free of cost in remote low socioeconomic regions.
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Risk of Death Associated With Intravitreal Anti-Vascular Endothelial Growth Factor Therapy: A Systematic Review and Meta-analysis.
Reibaldi, M, Fallico, M, Avitabile, T, Bonfiglio, V, Russo, A, Castellino, N, Parisi, G, Longo, A, Pulvirenti, A, Boscia, F, et al
JAMA ophthalmology. 2020;(1):50-57
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Abstract
IMPORTANCE Although intravitreal anti-vascular endothelial growth factor (VEGF) treatment represents the first-line therapy for many retinal diseases, the issue of their systemic safety is debatable. OBJECTIVES To assess whether intravitreal anti-VEGF therapy might be associated with increased risk of mortality and which variables are associated with the increase. DATA SOURCES PubMed, MEDLINE, and Embase databases, the Cochrane Library, and ClinicalTrials.gov were systematically searched from inception to May 6, 2019. STUDY SELECTION Randomized clinical trials comparing intravitreal anti-VEGF treatment with control groups and with follow-up of at least 6 months were selected. DATA EXTRACTION AND SYNTHESIS Data were independently collected by 2 investigators. Meta-analyses were conducted using the frequentist and Bayesian methods. For the frequentist approach, random- and fixed-effects models were used, with random-effects models considered the primary technique. Odds ratios (ORs) with 95% CIs were computed. For the bayesian approach, uninformative and informative priors were used. Odds ratios with 95% credible intervals (CrIs) were computed. Meta-regression analyses were based on random-effects models. MAIN OUTCOMES AND MEASURES The primary outcome measure was the all-cause death rate. Secondary outcomes included meta-regression analyses on the following variables: type of drug, number of injections, follow-up time, diagnosis, and cardiovascular risk. RESULTS Of 2336 studies identified, 34 unique studies with 8887 unique participants were included in the present meta-analysis. For the frequentist analysis, fixed- and random-effects models yielded similar estimates (ORs, 1.34 [95% CI, 0.95-2.07; P = .09] and 1.34 [95% CI, 0.89-2.01; P = .17], respectively). For the Bayesian approach, noninformative and informative priors yielded similar results (ORs, 1.34 [95% CrI, 0.79-2.34; 0.13 probability of OR≤1.00] and 1.40 [95% CrI, 0.82-2.32; 0.11 probability of OR≤1.00], respectively). Meta-regression analyses showed the following risk for 1 injection more: frequentist OR of 1.12 (95% CI, 1.04-1.22; P = .005) and Bayesian OR of 1.06 (95% CrI, 0.98-1.15; 0.06 probability of OR≤1.00). CONCLUSIONS AND RELEVANCE In this study, no difference was found in the mortality rate between intravitreal anti-VEGF treatment and control groups. Additional data seem warranted to determine whether the mortality rate is increased in patients receiving a greater number of injections.
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Efficacy of Conversion to Aflibercept for Diabetic Macular Edema Previously Refractory to Bevacizumab or Ranibizumab: A Meta-analysis of High-Quality Nonrandomized Studies.
Xiao, K, Li, FZ, Liang, SZ, Wang, J, Qian, C, Wan, GM
The Annals of pharmacotherapy. 2020;(8):750-756
Abstract
Background: Aflibercept has been widely used in treating diabetic macular edema (DME). However, the effect of aflibercept in treating DME refractory to bevacizumab or ranibizumab has not been well established. Objective: To assess the therapeutic effect of switching from bevacizumab or ranibizumab to aflibercept in the treatment of refractory DME. Methods: Relevant studies were searched from 3 databases: the Cochrane Library, PubMed, and Web of Science. Data on changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and adverse events within the follow-up period were collected and pooled using weighted mean differences (WMDs) with corresponding 95% CIs in a random effects model. The between-study heterogeneity was tested using the χ2 test and the I2 statistic, and funnel plots were used to evaluate the publication bias. Results: A total of 11 nonrandomized trials met the inclusion criteria and were included in the meta-analysis. Our studies showed significant improvements in the BCVA (WMD = 100.55; 95% CI = 68.46 to 132.63; P < 0.01) and reduction in CMT (WMD = 0.09; 95% CI = 0.03 to 0.14; P < 0.01) after switching to aflibercept. Although a large amount of heterogeneity was detected in the CMT results among these studies, the sensitivity analyses showed the reliability and stability of our results. Conclusion and Relevance: There were significant improvements in both visual and anatomical outcomes after switching from bevacizumab or ranibizumab to aflibercept, without risk of adverse events. Thus, switching therapy may be a safe and effective treatment for patients with refractory DME.
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Intravitreal corticosteroid implant vs intravitreal ranibizumab for the treatment of macular edema: a meta-analysis of randomized controlled trials.
Wei, Q, Chen, R, Lou, Q, Yu, J
Drug design, development and therapy. 2019;:301-307
Abstract
PURPOSE The purpose of this meta-analysis was to compare the efficacy and safety of corticosteroid implant and intravitreal ranibizumab for the treatment of macular edema (ME). MATERIALS AND METHODS PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials were comprehensively searched for studies comparing dexamethasone implant with ranibizumab in patients with ME. Best-corrected visual acuity (BCVA), central subfield thickness (CST), and adverse events were extracted from the final eligible studies. RevMan 5.3 software was used to analyze the data, and the modified Jadad assessment tool was used to access the quality of outcomes. RESULTS Three randomized controlled trials (RCTs) were included in our analysis. The types of causes of ME include central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), and diabetic retinopathy (DR). The ranibizumab treatment group had significantly better BCVA compared with the corticosteroid treatment group (standard mean difference [SMD] -0.80; 95% CI -1.08, -0.53; P<0.00001). The ranibizumab treatment group also had higher CST reduction compared with the corticosteroid treatment group, and there was a significant difference (weighted mean difference [WMD] 167.58; 95% CI 125.21-209.95; P<0.00001). There was no significant difference in serious adverse effects between the two groups (SMD 1.67; 95% CI 0.69, 4.05; P=0.26). However, the use of corticosteroid implant had a higher risk of intraocular pressure (IOP) (OR 6.88; 95% CI 4.53-10.44; P<0.00001) elevation and cataract (OR 3.98; 95% CI 1.89-8.37; P=0.0003) than ranibizumab treatment and fewer injections. CONCLUSIONS Compared with ranibizumab, corticosteroid implant did not have greater improved BCVA, but corticosteroid implant had less CST reduction. The advantages of corticosteroids are fewer injections, while the advantages of ranibizumab include fewer side effects.
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A meta-analysis of the effect of a dexamethasone intravitreal implant versus intravitreal anti-vascular endothelial growth factor treatment for diabetic macular edema.
He, Y, Ren, XJ, Hu, BJ, Lam, WC, Li, XR
BMC ophthalmology. 2018;(1):121
Abstract
BACKGROUND This meta-analysis evaluated the effectiveness and safety of dexamethasone (DEX) implant and intravitreal anti-vascular endothelial growth factor (VEGF) treatment for diabetic macular edema (DME). METHODS The PubMed, Embase, clinicaltrials.gov website and Cochrane Library databases were comprehensively searched for studies comparing DEX implant with anti-VEGF in patients with DME. Best-corrected visual acuity (BCVA), central subfield thickness (CST) and adverse events were extracted from the final eligible studies. Review Manager (RevMan) 5.3 for Mac was used to analyze the data and GRADE profiler were used to access the quality of outcomes. RESULTS Based on four randomized clinical trials assessing a total of 521 eyes, the DEX implant can achieve visual acuity improvement for DME at rates similar to those achieved via anti-VEGF treatment (mean difference [MD] = - 0.43, P = 0.35), with superior anatomic outcomes at 6 months (MD = - 86.71 μm, P = 0.02), while requiring fewer injections, in comparison to anti-VEGF treatment. Although the mean reduction in CST did not showed significant difference at 12 months (MD = - 33.77 μm, P = 0.21), the significant in BCVA from baseline to 12 months supported the anti-VEGF treatment (MD = - 3.26, P < 0.00001). No statistically significant differences in terms of the serious adverse events. However, use of the DEX implant has higher risk of intraocular pressure elevation and cataract than anti-VEGF treatment. CONCLUSIONS Compared with anti-VEGF, DEX implant improved anatomical outcomes significantly. However, this did not translate to improved visual acuity, which may be due to the progression of cataract. Therefore, the DEX implant may be recommended as a first chioce for select cases, such as for pseudophakic eyes, anti-VEGF-resistant eyes, or patients reluctant to receive intravitreal injections frequently.
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ILM peeling in nontractional diabetic macular edema: review and metanalysis.
Rinaldi, M, dell'Omo, R, Morescalchi, F, Semeraro, F, Gambicorti, E, Cacciatore, F, Chiosi, F, Costagliola, C
International ophthalmology. 2018;(6):2709-2714
Abstract
PURPOSE To evaluate the effect of internal limiting membrane (ILM) peeling during vitrectomy for nontractional diabetic macular edema. METHODS PUBMED, MEDLINE and CENTRAL were reviewed using the following terms (or combination of terms): diabetic macular edema, nontractional diabetic macular edema, internal limiting membrane peeling, vitrectomy, Müller cells. Randomized and nonrandomized studies were included. The eligible studies compared anatomical and functional outcomes of vitrectomy with or without ILM peeling for tractional and nontractional diabetic macular edema. Postoperative best-corrected visual acuity and central macular thickness were considered, respectively, the primary and secondary outcomes. Meta-analysis on mean differences between vitrectomy with and without ILM peeling was performed using inverse variance method in random effects. RESULTS Four studies with 672 patients were eligible for analysis. No significant difference was found between postoperative best-corrected visual acuity or best-corrected visual acuity change of ILM peeling group compared with nonpeeling group. There was no significant difference in postoperative central macular thickness and central macular thickness reduction between the two groups. CONCLUSIONS The visual acuity outcomes in patients affected by nontractional diabetic macular edema using pars plana vitrectomy with ILM peeling versus no ILM peeling were not significantly different. A larger prospective and randomized study would be necessary.