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Intervention Review

Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for diabetic macular oedema

  1. Mariacristina Parravano1,*,
  2. Francesca Menchini2,
  3. Gianni Virgili3

Editorial Group: Cochrane Eyes and Vision Group

Published Online: 7 OCT 2009

Assessed as up-to-date: 15 APR 2009

DOI: 10.1002/14651858.CD007419.pub2


How to Cite

Parravano M, Menchini F, Virgili G. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for diabetic macular oedema. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD007419. DOI: 10.1002/14651858.CD007419.pub2.

Author Information

  1. 1

    Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmolologia-IRCCS, Ophthalmology, Rome, Italy

  2. 2

    University of Udine, Azienda Ospedaliero-universitaria di Udine, Department of Ophthalmology, Udine, Italy

  3. 3

    University of Florence, Department of Neuro-Oto-Ophthalmological Surgical Sciences, Eye Clinic, Florence, Italy

*Mariacristina Parravano, Ophthalmology, Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmolologia-IRCCS, Via Livenza n 3, Rome, 00198, Italy. criparra@tin.it.

Publication History

  1. Publication Status: New
  2. Published Online: 7 OCT 2009

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Diabetic macular oedema (DMO) is a common complication of diabetic retinopathy. The retina at the macula thickens and this can cause gradual loss of central vision. Although grid or focal laser photocoagulation has been shown to reduce the risk of visual loss in DMO or clinically significant macular oedema (CSMO), vision is rarely improved. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) modalities has recently been proposed for improving vision in people with DMO. Anti-VEGF drugs are delivered by an injection in the vitreous cavity of the eye.

Objectives

This review aims to assess the effectiveness of anti-VEGF therapy for preserving or improving vision in people with DMO.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE and Caribbean Literature on Health Sciences (LILACS). There were no language or date restrictions in the search for trials.The electronic databases were last searched on 16 April 2009.

Selection criteria

We included randomised controlled trials (RCTs) comparing any antiangiogenic drugs with an anti-VEGF mechanism of action compared to another treatment, sham treatment, or no treatment.

Data collection and analysis

Two authors independently extracted the data. The risk ratio (RR) of visual loss and visual gain of 3 or more lines was estimated at least six months after treatment.

Main results

We found four small studies that collected only short-term outcomes (24 to 36 weeks); three of which had more than two randomisation groups generating five types of comparisons overall. Only one comparison included more than one trial in the analysis. The short-term outcome was the mean change in LogMAR visual acuity. One study on 172 patients compared three doses of pegaptanib versus sham (about 5 injections on average) and another compared bevacizumab or bevacizumab plus triamcinolone with sham (multiple bevacizumab injections and a single triamcinolone injection in 101 patients, 115 eyes overall) in patients with CSMO that was refractory to photocoagulation. Bevacizumab or bevacizumab plus triamcinolone were also compared to photocoagulation in 129 patients with untreated CSMO (150 eyes, multiple injections needed in 24 patients). Although comparisons tended to favour antiangiogenic therapy, estimates did not reach statistical significance or, if they did, they were not robust to sensitivity analysis regarding missing data and potential bias related to single trial estimates. No difference could be demonstrated in one study on 26 patients comparing bevacizumab to triamcinolone (both administered with a single injection) and between bevacizumab and bevacizumab plus triamcinolone in two studies on 182 patients. All the studies in this review, except for the study on pegaptanib, were at risk of bias based on the assessment of six methodological quality items.

There were no serious adverse effects in these short-term studies, except for one case of severe anterior uveitis in one eye treated with bevacizumab. No included study examined long-term adverse effects of antiangiogenic therapy.

Authors' conclusions

There is not sufficient high quality evidence from large RCTs supporting the use of either single or multiple anti-VEGF intravitreal injections to treat DMO. Results from ongoing studies on several compounds should assess not only treatment efficacy but also, if a benefit is found, the number of injections needed for maintenance and long-term safety.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Antiangiogenic therapy for diabetic macular oedema

Diabetic macular oedema (DMO) is a common complication of diabetic retinopathy. The retina at the macula thickens and this can cause gradual loss of central vision. Grid or focal laser photocoagulation is effective in treating DMO and has been used for several years, but vision is rarely improved. Antiangiogenic therapy with anti-vascular endothelial growth factor (anti-VEGF) modalities has recently been proposed to try to improve vision in people with DMO. Anti-VEGF drugs are delivered by an injection in the vitreous cavity of the eye.

We included four studies in this review. We found two small studies, comparing pegaptanib with sham or bevacizumab with sham in patients with CSMO, that showed results in favour of antiangiogenic therapy but could not reliably demonstrate a benefit. An additional small study compared bevacizumab to photocoagulation in eyes with untreated CSMO and its results also favoured antiangiogenic therapy, but not reliably so. Other comparisons were between bevacizumab and triamcinolone, or between bevacizumab alone and bevacizumab plus triamcinolone in three studies which did not show a difference. Three out of the four studies were at risk of bias.

Antiangiogenic treatment was well tolerated in these studies, but since all studies were short-term, we were unable to investigate long-term effects as well as risks. Although several studies are ongoing, there is not sufficient high quality evidence on the use of anti-VEGF drugs for the treatment of DMO yet.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

以抗血管內皮生長因子模式的抗血管生成療法用於治療糖尿病的黃斑部水腫

糖尿病黃斑部水腫(Diabetic macular oedema (DMO))是一種常見的糖尿病視網膜病變的併發症。黃斑部視網膜增厚會造成漸進式喪失中央視力。雖然網格狀或局部雷射光凝固療法顯示可以減少DMO或具臨床意義之黃斑部水腫(clinically significant macular oedema (CSMO))視力喪失的風險,但視力很少獲得改善。最近提出以抗血管內皮生長因子(antivascular endothelial growth factor (antiVEGF))模式的抗血管生成療法用來改善DMO患者的視力。抗VEGF藥物的給予方式是將之注射於眼睛的玻璃體腔內。

目標

這篇回顧的目的為評估抗VEGF療法用於維持或改善DMO患者視力的效果。

搜尋策略

我們檢索考科藍圖書館中的the Cochrane Central Register of Controlled Trials (CENTRAL),MEDLINE,EMBASE與Caribbean Literature on Health Sciences (LILACS)。檢索試驗的條件不限制語言及日期。電子資料庫的最後一次更新是在2009年4月16日。

選擇標準

我們納入比較任何具有抗VEGF作用機制之抗血管生成藥物相較於其他治療,偽裝治療,或無治療的隨機對照試驗(randomised controlled trials (RCTs))。

資料收集與分析

兩名作者分別摘錄資料。至少治療六個月後才評估視力喪失與視力獲得3行或以上的相對風險(risk ratio (RR))。

主要結論

我們發現四篇只蒐集短期結果(24至36週)的小型研究;其中三篇有兩個以上的隨機分配組以組成五種比較類型。只有一種比較類型在分析時有含括一篇以上的試驗。短期結果為LogMAR視力的平均改變量。有一篇比較三種pegaptanib劑量對照偽裝法(平均約注射5次)用於172名病患的研究,而其他則比較bevacizumab或bevacizumab合併triamcinolone與偽裝法(101名病患,總共115隻眼睛,多次注射bevacizumab與單次注射triamcinolone)用於對光凝固療法難治之CSMO病患。另外也比較bevacizumab或bevacizumab合併triamcinolone相較於光凝固療法用於未治療CSMO的129名病患(150隻眼睛,24名需要多次注射的病患)。雖然比較的結果偏好抗血管生成療法,但估計值並未達到統計顯著性,或者,如果達到統計顯著性,但他們沒有關於遺漏資料與單一試驗估計可能產生偏差的敏感度分析。無法證明比較bevacizumab與triamcinolone(皆單次注射)用於26名病患的研究,以及兩篇比較bevacizumab與bevacizumab合併triamcinolone用於182名病患的研究具有差異。這篇回顧中的所有研究,除了pegaptanib的研究外,皆具有六項方法學品質評估的偏差風險。除了一個以bevacizumab治療單眼嚴重的前葡萄膜炎案例外,這些短期的研究沒有嚴重的負面影響。納入的研究沒有評估長期的抗血管生成療法的負面影響。

作者結論

沒有來自大型隨機對照試驗之足夠的高品質證據可以支持使用單次或多次抗VEGF玻璃體注射以治療DMO。關於一些化合物持續進行的研究結果不應只評估治療的效益,如果發現其利益,另外也應評估所需注射的次數以維持效益與長期安全性。

翻譯人

本摘要由高雄榮民總醫院金沁琳翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

抗血管生成療法用來治療糖尿病黃斑部水腫。糖尿病黃斑部水腫(DMO)是一種常見的糖尿病視網膜病變的併發症。黃斑部視網膜增厚會造成漸進式喪失中央視力。網格狀或局部的雷射光凝固療法對於治療DMO有效且已使用數年,但視力卻很少獲得改善。最近提出以抗血管內皮生長因子(抗VEGF)模式的抗血管生成療法用來嘗試改善DMO患者的視力。抗VEGF藥物的給予方式是將之注射於眼睛的玻璃體腔內。這篇回顧納入四篇研究。我們發現兩篇比較pegaptanib與偽裝法或bevacizumab與偽裝法用於CSMO病患的小型研究,其顯示研究結果偏好抗血管生成療法,但無法可靠地證明其效益。另一篇小型研究比較bevacizumab與光凝固療法用於未治療之CSMO病患的眼睛,結果也偏好抗血管生成療法,但結果並不可靠。其他則比較bevacizumab與triamcinolone,或單一的bevacizumab與bevacizumab合併triamcinolone,三篇研究結果未顯示具有差異。四篇研究中的三篇具有偏差風險。這些研究中抗血管生成療法其耐受性良好,但因為所有的研究為短期的,我們無法調查長期的效果與風險。雖然有幾篇研究仍在進行中,但沒有充分關於使用抗VEGF藥物治療DMO之高品質的證據。