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Comparison of the efficacy and safety of drug therapies for macular edema secondary to central retinal vein occlusion.

ABSTRACT: OBJECTIVES:To evaluate the efficacy and safety of anti-vascular endothelial growth factor (VEGF) agents and corticosteroids for the treatment of macular oedema (ME) secondary to central retinal vein occlusion (CRVO). DESIGN:Systematic review and network meta-analysis. PARTICIPANTS:Patients from previously reported randomised controlled trials (RCTs) comparing anti-VEGF and corticosteroids for the treatment of ME secondary to CRVO. METHODS:Literature searches were conducted using PubMed, Medline, Embase, Cochrane Library and clinicaltrials.gov until March 2017. Therapeutic effects were estimated using the proportions of patients gaining/losing ?15 letters, best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Treatment safety was estimated using the proportions of adverse events, namely increased intraocular pressure (IOP), cataracts, vitreous haemorrhage (VH) and retinal tear. The software ADDIS (V.1.16.8) was used for analysis. Treatment effect and safety of different drugs could be ranked based on simulation. RESULTS:Eleven RCTs comprising 2060 patients were identified. Regarding patients gaining ?15 letters, aflibercept and ranibizumab were significantly more effective than sham/placebo at 6 months. Regarding patients losing ?15 letters at 6 months, ranibizumab showed significant improvement compared with dexamethasone. Aflibercept, bevacizumab or ranibizumab showed greater improvements in BCVA than sham/placebo at 6 months. Intravitreal ranibizumab injection demonstrated greater CRT reduction than both sham and dexamethasone did. Dexamethasone had a higher risk of increased IOP than aflibercept and ranibizumab. Ranibizumab demonstrated a greater risk of cataracts than dexamethasone. Aflibercept and ranibizumab demonstrated low incidence of VH and retinal tear, respectively. Aflibercept had a slight advantage over ranibizumab as assessed by benefit-risk analysis. CONCLUSIONS:Anti-VEGF agents have advantages in the treatment of ME secondary to CRVO. Aflibercept and ranibizumab showed marked BCVA improvement and CRT reduction. Aflibercept may have a slight advantage over ranibizumab. The results of this study can serve as a reference for clinicians to provide patient-tailored treatment. PROSPERO REGISTRATION NUMBER:CRD42017064076.

SUBMITTER: Qian T

PROVIDER: S-EPMC6318534 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Comparison of the efficacy and safety of drug therapies for macular edema secondary to central retinal vein occlusion.

Qian Tianwei T Zhao Mengya M Wan Yongjing Y Li MengXiao M Xu Xun X

BMJ open 20181228 12

<h4>Objectives</h4>To evaluate the efficacy and safety of anti-vascular endothelial growth factor (VEGF) agents and corticosteroids for the treatment of macular oedema (ME) secondary to central retinal vein occlusion (CRVO).<h4>Design</h4>Systematic review and network meta-analysis.<h4>Participants</h4>Patients from previously reported randomised controlled trials (RCTs) comparing anti-VEGF and corticosteroids for the treatment of ME secondary to CRVO.<h4>Methods</h4>Literature searches were con ...[more]

PMID: 30593547

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Project description:BackgroundCentral retinal vein occlusion (CRVO) is a common retinal vascular disorder in which macular edema (ME) may develop, with a consequent reduction in visual acuity. The visual prognosis in CRVO-ME is poor in a substantial proportion of patients, especially those with the ischemic subtype, and until recently there has been no treatment of proven benefit. Macular grid laser treatment is ineffective, and whilst a few recent randomized controlled trials (RCTs) suggest short-term gains in visual acuity with intravitreal steroids for patients with non-ischemic CRVO-ME, there is no established treatment for ischemic CRVO-ME. Anti-vascular endothelial growth factor (anti-VEGF) agents have been used to treat ME resulting from a variety of causes and may represent a treatment option for CRVO-ME.ObjectivesTo investigate the effectiveness and safety of intravitreal anti-VEGF agents in the treatment of CRVO-ME.Search strategyWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2010, Issue 8), MEDLINE (January 1950 to August 2010), EMBASE (January 1980 to August 2010), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to August 2010), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (January 1937 to August 2010), OpenSIGLE (January 1950 to August 2010), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) and ClinicalTrials.gov (www.clinicaltrials.gov). There were no language or date restrictions in the search for trials. The electronic databases were last searched on 10 August 2010.Selection criteriaWe considered RCTs that compared intravitreal anti-VEGF agents of any dose or duration to sham injection or no treatment. We focused on studies that included individuals of any age or gender with unilateral or bilateral disease and a minimum of six months follow up. Secondarily, we considered non-randomized studies with the same criteria, but did not conduct a separate electronic search for these.Data collection and analysisTwo review authors independently assessed trial quality and extracted data.Main resultsWe found two RCTs that met the inclusion criteria after independent and duplicate review of the search results. These RCTs utilized different anti-VEGF agents which cannot be assumed to be directly comparable. We, therefore, performed no meta-analysis. Evidence from these trials and from other non-randomized case series is summarized in this review.Authors' conclusionsRanibizumab and pegaptanib sodium have shown promise in the short-term treatment of non-ischemic CRVO-ME. However, effectiveness and safety data from larger RCTs with follow up beyond six months are not yet available. There are no RCT data on anti-VEGF agents in ischemic CRVO-ME. The use of anti-VEGF agents to treat this condition therefore remains experimental.

Project description:BackgroundThe comparative safety and efficacy of different doses of intravitreal triamcinolone acetonide (IVTA) for diabetic macular edema (DME) and macular edema (ME) secondary to retinal vein occlusion (RVO) is unclear.ObjectivesThis meta-analysis aimed to compare the safety and efficacy of different doses of IVTA in this setting.MethodsA systematic literature search for randomized clinical trials (RCTs) was conducted on Cochrane Library, Ovid MEDLINE, and EMBASE from January 2005 to May 2022. Studies that reported on patients with DME or ME secondary to RVO that received treatment with different doses of IVTA were included. A random-effects meta-analysis was performed. Cochrane's Risk of Bias Tool 2 was used to assess the risk of bias, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) guidelines were used to assess certainty of evidence.ResultsFive RCTs reporting on 1,041 eyes at baseline were included in this meta-analysis. In eyes with ME secondary to RVO, high-dose (4 mg) IVTA achieved a significantly better change in best-corrected visual acuity (WMD = -4.75 ETDRS letters, 95% CI = [-7.73, -1.78], p = 0.002) and reduction in retinal thickness (WMD = -93.02 μm, 95% CI = [-153.23, -32.82], p = 0.002) at months 4-6 compared to low-dose (1-2 mg) IVTA. However, high-dose IVTA had a higher risk of intraocular pressure-related adverse events (RR = 2.99, 95% CI = [1.05, 8.50], p = 0.04) and cataract surgery (RR = 5.67, 95% CI = [3.09, 10.41], p < 0.00001) than low-dose IVTA in eyes with ME secondary to RVO. These efficacy and safety differences in high-dose and low-dose IVTA were not observed in DME eyes.ConclusionsThe RCT evidence in this setting is limited. High-dose IVTA achieved greater improvements in visual acuity and reductions in retinal thickness than low-dose IVTA at months 4-6. However, high-dose IVTA had a less favorable safety profile than low-dose IVTA. The significance of these outcomes was based on patients with ME secondary to RVO, but not DME.

Project description:PurposeTo evaluate the cost-utility of treatment for macular edema in central retinal vein occlusion (CRVO) using intravitreal injections of the anti-vascular endothelial growth factor (VEGF) agents bevacizumab, ranibizumab, and aflibercept.DesignDecision analysis model of cost-utility.ParticipantsData from study participants in the Lucentis, Eylea, Avastin in Vein Occlusion (LEAVO) study.MethodsA decision analysis of a disease simulation model was used to calculate comparative cost-utility of intravitreal bevacizumab (IVB), intravitreal ranibizumab (IVR), and intravitreal aflibercept (IVA) for the treatment of macular edema associated with CRVO based on data from the LEAVO study. Center for Medicare and Medicaid Services data were used to calculate associated modeled costs in a hospital- or facility-based and nonfacility setting from a third-party payer perspective, and societal costs also were calculated. Cost utility was calculated based on the preserved visual utility during the 2 years of the study and also by estimating utility for the expected lifetime.Main outcome measuresCost of treatment, cost per quality-adjusted life-year (QALY), and incremental cost-effectiveness ratio (ICER).ResultsFrom the third-party payer perspective, the estimated lifetime costs per QALY in the facility and nonfacility settings were $39 325 and $17 944, respectively, for IVB; $114 095 and $92 653, respectively, for IVR; and $78 935 and $63 270, respectively, for IVA. From the societal perspective, the estimated lifetime costs per QALY in the facility setting were $52 754 for IVB, $128 242 for IVR, and $86 262 for IVA. The ICER of IVA compared with that of IVB was $153 633/QALY from the third-party facility setting and $152 992/QALY from the societal perspective. The use of IVB compared with IVR and IVA compared with IVR were cost-saving interventions (ICER, <0) regardless of the perspective or setting.ConclusionsIn the treatment of macular edema in CRVO, IVB yields the best cost utility among the 3 anti-VEGF agents modeled. Intravitreal aflibercept maintains acceptable lifetime cost per QALY while having a favorable cost utility compared with IVR.

Project description:BackgroundCentral retinal vein occlusion (CRVO) associates with severe vision outcome and no proven beneficial treatment. Our meta-analysis intended to appraise the efficacy and safety of anti-vascular endothelial growth factor (anti-VEGF) agents in macular edema (ME) following CRVO.MethodsData were collected and analyzed by Review Manager 5.2.1. We employed a random-effects model to eliminate between-study heterogeneity. Nfs (called fail-safe number) was calculated to evaluate the publication bias.ResultsWe included 5 trials consisting 323 cases and 281 controls. Primary outcomes showed that overall comparison of anti-VEGF agents with placebo control yielded a 374% and 136% increased tendency for a gain of 15 letters or more on Early Treatment Diabetic Retinopathy Study (ETDRS) chart (95% confidence interval [95% CI]: 2.43-9.23; P<0.00001; I(2) = 59%, 95% CI: 1.60-3.49; P<0.0001; I(2) ?= 0%, respectively) at 6 and 12 months. Secondary outcomes showed that a 90% and 77% decreased risk at 6 and 12 months for a loss of 15 letters or more. The overall mean difference showed a statistically significance in best-corrected visual acuity (BCVA) on each time point. However, changes of central retinal thickness (CRT) lost significance at 12 months after 6-month as-needed treatment. The incidence of adverse events (AEs) had no statistical difference between anti-VEGF and placebo groups. Subgroup analyses indicated that patients receiving Aflibercept got the highest tendency to gain 15 letters or more (OR = 9.78; 95% CI: 4.43-21.56; P<0.00001). Age controlled analysis suggested a weaken tendency of BCVA improvement in age over 50 (MD = 12.26; 95% CI: 7.55-16.98; P<0.00001). Subgroup analysis by clinical classification showed a strengthen difference of BCVA changes at 6 months in ischemic type (MD = 19.65 letters, 95% CI: 13.15 to 26.14 letters, P<0.00001).ConclusionsOur results showed that anti-VEGF agents were superior to placebo in CRVO-ME treatment with no statistically significant AEs, especially in younger people and for ischemic type.

Project description:PurposeTo assess the relationship between best-corrected visual acuity (BCVA) and anatomic features in patients with macular edema (ME) related to retinal vein occlusion (RVO).DesignPost hoc analysis of 3 clinical trials, which included verified diagnoses, protocol refractions, and the assessment of OCT and fluorescein angiography (FA) images at a masked reading center.ParticipantsPatients diagnosed with RVO-ME.MethodsCorrelation analyses were performed to determine the correlation between BCVA and macular anatomy at baseline and at 12 and 24 weeks and between changes from baseline to 12 and 24 weeks.Main outcome measuresThe correlations between BCVA and central subfield thickness (CST), ellipsoid zone (EZ) integrity, intraretinal fluid (IRF), subretinal fluid, central leakage, and ischemia were assessed.ResultsIn a total of 828 eyes with RVO-ME, the mean age, BCVA, and CST at baseline was 64.7 years, 51.1 letters, and 656.9 μm, respectively. At baseline, a moderate negative correlation was observed between BCVA and CST (r = - 0.56, P < 0.001). At weeks 12 and 24, the mean BCVA of eyes with definitely abnormal (absent) EZ was statistically significantly worse than that of eyes with normal EZ. At week 12, a moderate negative correlation was observed between changes in BCVA and changes in CST (r = - 0.35, P < 0.001), with a similar degree of association noted at week 24 (r = - 0.35, P < 0.001). At weeks 12 and 24, eyes that showed any improvement in central IRF showed a greater improvement in BCVA than eyes that showed no improvement worsening (week 12: 463 eyes, 18.3 letters vs. 177 eyes, 13.0 letters, respectively, P < 0.001) and (week 24: 332 eyes, 20.2 letters vs. 131 eyes, 13.3 letters, respectively, P < 0.001). With respect to the correlation between baseline BCVA and fluorescein leakage or capillary nonperfusion, the Pearson correlation coefficients were - 0.41 (P < 0.001) and - 0.16 (P = 0.060), respectively.ConclusionsIn addition to CST, there are important clinically relevant relationships between BCVA and both OCT and FA anatomic features in patients with RVO-ME.

Project description:BACKGROUND:Intravitreal agents have replaced observation in macular edema in central (CRVO) and grid laser photocoagulation in branch retinal vein occlusion (BRVO). We conducted a systematic review to evaluate efficacy and safety outcomes of intravitreal therapies for macular edema in CRVO and BRVO. METHODS AND FINDINGS:MEDLINE, Embase, and the Cochrane Library were systematically searched for RCTs with no limitations of language and year of publication. 11 RCTs investigating anti-VEGF agents (ranibizumab, bevacizumab, aflibercept) and steroids (triamcinolone, dexamethasone implant) with a minimum follow-up of 1 year were evaluated. EFFICACY CRVO:Greatest gain in visual acuity after 12 months was observed both under aflibercept 2 mg: +16.2 letters (8.5 injections), and under bevacizumab 1.25 mg: +16.1 letters (8 injections). Ranibizumab 0.5 mg improved vision by +13.9 letters (8.8 injections). Triamcinolone 1 mg and 4 mg stabilized visual acuity at a lower injection frequency (-1.2 letters, 2 injections). BRVO:Ranibizumab 0.5 mg resulted in a visual acuity gain of +18.3 letters (8.4 injections). The effect of dexamethasone implant was transient after 1.9 implants in both indications. SAFETY:Serious ocular adverse events were rare, e.g., endophthalmitis occurred in 0.0-0.9%. Major differences were found in an indirect comparison between steroids and anti-VEGF agents for cataract progression (19.8-35.0% vs. 0.9-7.0%) and in required treatment of increased intraocular pressure (7.0-41.0% vs. none). No major differences were identified in systemic adverse events. CONCLUSIONS:Anti-VEGF agents result in a promising gain of visual acuity, but require a high injection frequency. Dexamethasone implant might be an alternative, but comparison is impaired as the effect is temporary and it has not yet been tested in PRN regimen. The ocular risk profile seems to be favorable for anti-VEGF agents in comparison to steroids. Because comparative data from head-to-head trials are missing currently, clinicians and patients should carefully weigh the benefit-harm ratio.

Dataset Information

Comparison of the efficacy and safety of drug therapies for macular edema secondary to central retinal vein occlusion.

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Comparison of the efficacy and safety of drug therapies for macular edema secondary to central retinal vein occlusion.

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