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Intervention Review

Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for neovascular age-related macular degeneration

  1. Satyanarayana S Vedula2,
  2. Magdalena Krzystolik1,*

Editorial Group: Cochrane Eyes and Vision Group

Published Online: 23 APR 2008

Assessed as up-to-date: 19 FEB 2008

DOI: 10.1002/14651858.CD005139.pub2


How to Cite

Vedula SS, Krzystolik M. Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for neovascular age-related macular degeneration. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD005139. DOI: 10.1002/14651858.CD005139.pub2.

Author Information

  1. 1

    Southern New England Retina Associates, Providence, USA

  2. 2

    Johns Hopkins Bloomberg School of Public Health, Cochrane Eyes and Vision Group US Project, Baltimore, MD, USA

*Magdalena Krzystolik, Southern New England Retina Associates, 1 Randall Square, Suite 206, Providence, RI 02703, USA. Magdalena_Krzystolik@brown.edu.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 23 APR 2008

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Abstract

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

Background

Age-related macular degeneration (AMD) is a common cause of severe vision loss in people 55 years and older.

Objectives

The objective of this review was to investigate the effects of anti-VEGF (vascular endothelial growth factor) modalities for treating neovascular AMD.

Search methods

We searched CENTRAL, MEDLINE, EMBASE and LILACS. We handsearched ARVO abstracts for 2006, 2007 for ongoing trials.

Selection criteria

We included randomized controlled trials (RCTs).

Data collection and analysis

Two review authors independently extracted data. We contacted trial authors for additional data. We summarized outcomes as relative risks (RR), number needed to treat (NNT) and weighted mean differences.

Main results

We included five RCTs of good methodological quality. All five trials were conducted by pharmaceutical companies. An intention-to-treat analysis using the last observation carried forward method was done in most trials.

Two trials compared pegaptanib versus sham. One trial compared ranibizumab versus sham, another compared ranibizumab/sham verteporfin PDT versus verteporfin PDT/sham ranibizumab, and the final trial compared ranibizumab plus verteporfin PDT versus verteporfin PDT alone.

Fewer patients treated with pegaptanib lost 15 or more letters of visual acuity at one year follow-up compared to sham (pooled relative risk (RR) 0.71; 95% confidence interval (CI) 0.61 to 0.84). The NNT was 6.67 (95% CI 4.35 to 14.28) for 0.3 mg pegaptanib, 6.25 (95% CI 4.17 to 12.5) for 1 mg pegaptanib and 14.28 (95% CI 6.67 to 100) for 3 mg pegaptanib. In a trial of ranibizumab versus sham, RR for loss of 15 or more letters visual acuity at one year was 0.14 (95% CI 0.1 to 0.22) in favour of ranibizumab. The NNT was 3.13 (95% CI 2.56 to 3.84) for 0.3 mg ranibizumab and 3.13 (95% CI 2.56 to 3.84) for 0.5 mg ranibizumab. In a trial of ranibizumab versus verteporfin PDT, RR for loss of 15 or more letters at one year was 0.13 (95% CI 0.07 to 0.23) favouring ranibizumab. The NNT was 3.33 (95% CI 2.56 to 4.76) for 0.3 mg ranibizumab and 3.12 (95% CI 2.43 to 4.17) for 0.5 mg ranibizumab. In another trial of combined ranibizumab plus verteporfin PDT versus verteporfin PDT, RR for loss of 15 or more letters at one year favoured combined therapy (RR 0.3 (95% CI 0.15 to 0.60). The NNT was 4.35 (95% CI 2.78 to 11.11).

Pooled RR for gain of 15 or more letters visual acuity at one year was 5.81 (95% CI 3.29 to 10.26) for ranibizumab versus sham, 6.79 (95% CI 3.41 to 13.54) for ranibizumab/sham verteporfin PDT versus verteporfin PDT/sham ranibizumab, and 4.44 (95% CI 1.40 to 14.08) for ranibizumab plus verteporfin PDT versus verteporfin PDT.

Frequency of endophthalmitis in included studies was between 0.7% to 4.7% with ranibizumab and 1.3% with pegaptanib. Improvement in vision-specific quality of life was reported for both treatments.

Authors' conclusions

Pegaptanib and ranibizumab reduce the risk of visual acuity loss in patients with neovascular AMD. Ranibizumab causes gains in visual acuity in many eyes. Quality of life and cost will be important for treatment decisions. Other agents blocking VEGF are being tested in ongoing trials.

 

Plain language summary

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

Antiangiogenic therapy with anti-vascular endothelial growth factor modalities for neovascular age-related macular degeneration

Age-related macular degeneration (AMD) is a common cause of severe vision loss in people 55 years and older. Neovascular AMD, which involves abnormal growth of blood vessels in the back of the eye, accounts for most AMD-related severe vision loss. Medications such as pegaptanib and ranibizumab that block this abnormal growth of blood vessels in the back of the eye are one way to treat this condition. Fewer patients treated with pegaptanib lost 15 or more letters visual acuity at one year. Ranibizumab alone and when combined with verteporfin photodynamic therapy (PDT) resulted in fewer patients losing 15 or more letters visual acuity at one year. Approximately seven patients need to be treated with 0.3 mg or 0.5 mg pegaptanib to prevent loss of 15 or more letters visual acuity in one patient. This number is about 14 for 3 mg pegaptanib. In contrast just over three patients need to be treated with either 0.3 mg or 0.5 mg doses of ranibizumab to prevent loss of 15 or more letters visual acuity. Very few patients treated with pegaptanib gained visual acuity. A greater proportion of patients treated with ranibizumab gained 15 of more letters visual acuity at one year compared with sham or verteporfin PDT. No trial directly compared pegaptanib and ranibizumab. Pegaptanib and ranibizumab are beneficial for treatment of neovascular AMD and their use is associated with few adverse effects. Trials on other agents that block abnormal growth of blood vessels in this condition are ongoing and will be included in updates of the review.

 

摘要

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

背景

用於血管新生之老年性黃斑部病變之抗血管內皮生長因子模式的抗血管新生療法

老年性黃斑部病變(Agerelated macular degeneration, AMD)是55歲以上民眾視覺喪失的常見原因之一。

目標

本回顧旨在探討抗血管內皮生長因子(antivascular endothelial growth factor, antiVEGF)治療血管新生老年性黃斑部病變之效果。

搜尋策略

我們蒐尋CENTRAL, MEDLINE, EMBASE和LILACS,並以手動蒐尋ARVO摘要以找尋2006, 2007年進行中之試驗。

選擇標準

我們納入隨機對照試驗(randomized controlled trials, RCTs)。

資料收集與分析

兩位審閱作者獨立地選取數據,我們連絡試驗作者索取額外的數據,整合結果以RR(relative risks),NNT(number needed to treat)及WMDs(weighted mean differences)表示之。

主要結論

我們納入5個方法品質好的RCTs,全數由製藥公司主導,大部份的研究都是採用最終觀察轉入法(last observation carried forward method)的治療意向分析(intentiontotreat analysis) ,兩個試驗是pegaptanib與sham比較,一個試驗是ranibizumab與sham比較,其他則是ranibizumab/sham verteporfin PDT 與 verteporfin PDT/sham ranibizumab比較,最後一個試驗是ranibizumab加上verteporfin PDT 與 verteporfin PDT 單用相比。與使用sham治療比較,以pegaptanib治療追蹤一年後視力敏銳喪失15個字母以上之危險相對較低(pooled RR 0.71; 95% CI 0.61至0.84)。0.3毫克 pegaptanib的NNT是 6.67 (95% CI 4.35 至 14.28), 1毫克pegaptanib 是6.25 (95% CI 4.17 至 12.5) 及 3毫克pegaptanib 14.28 (95% CI 6.67 至 100)。一個ranibizumab與sham相較的試驗,一年視力喪失超過15個字母的RR 0.14 (95% CI 0.1 至 0.22),ranibizumab較佳;0.3毫克ranibizumab NNT 是3.13 (95% CI 2.56至3.84) 和 0.5毫克ranibizumab 3.13 (95% CI 2.56 至 3.84)。一個ranibizumab與verteporfin PDT 相較的試驗,一年視力喪失超過15個字母的RR 0.13 (95% CI 0.07 至 0.23),ranibizumab較佳;0.3毫克ranibizumab NNT是3.33 (95% CI 2.56至4.76) 和 0.5毫克ranibizumab 3.12 (95% CI 2.43至4.17)。另一個ranibizumab併用verteporfin PDT與單用verteporfin PDT相較,一年視力喪失超過15個字母的RR 0.3(95% CI 0.15至0.60),合併治療組較佳;NNT是4.35 (95% CI 2.78至11.11)。Ranibizumab與sham相較,一年視力獲得超過15個字母的RR 5.81 (95% CI 3.29 至 10.26),ranibizumab/sham verteporfin PDT 與 verteporfin PDT/sham ranibizumab比較(RR 6.79, 95% CI 3.41 至 13.54),ranibizumab併用verteporfin PDT與單用verteporfin PDT相較(RR4.44, 95% CI 1.40 至 14.08)。研究中眼內炎的發生機會,ranibizumab是0.7%至4.7%,pegaptanib是1.3%,兩者治療都可改善視力方面的生活品質。

作者結論

Pegaptanib和ranibizumab可減少新生血管AMD患者視力喪失的風險,ranibizumab能讓許多眼睛重獲視力,生活品質與花費是決定接受治療的重要考量,其他阻斷VEGF藥劑正進行試驗中。

翻譯人

本摘要由高雄榮民總醫院毛志民翻譯。

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

總結

老年性黃斑部病變血管新生之抗血管內皮生長因子模式的抗血管新生療法可治療此疾。血管新生之AMD係眼部背面血管異常生長,可解釋大多數AMD相關嚴重視力喪失,pegaptanib 和 ranibizumab等藥物阻斷眼睛背面血管不正常生長,成為治療此症狀的方法。以pegaptanib治療讓較少病人的ㄧ年視力喪失15個字母以上,單用ranibizumab及併用verteporfin光動力療法(photodynamic therapy, PDT)的結果亦然。以0.3 mg 或 0.5 mg pegaptanib治療約7位患者,可以防止一位患者視力喪失達15字母以上,3 mg pegaptanib則需治療約14位患者才有一位有效。相反地,以0.3 mg 或 0.5 mg ranibizumab治療,僅須治療3位患者即可有一位有效。非常少的患者以pegaptanib治療重獲視力;相較sham或verteporfin PDT,以ranibizumab治療者則於一年重獲15個字母以上的比例較高。尚無試驗直接將pegaptanib與ranibizumab相比較,Pegaptanib和ranibizumab治療血管新生AMD是有助益的,伴隨少數不良反應;其他針對這病況,阻斷血管異常生長的藥物試驗正進行中,將於本回顧更新時被納入。