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A Systematic Review of Intravitreal Bevacizumab for the Treatment of Diabetic Macular Edema [Internet]

A Systematic Review of Intravitreal Bevacizumab for the Treatment of Diabetic Macular Edema [Internet]

Rapid Response Report: Peer-Reviewed Summary with Critical Appraisal - Canadian Agency for Drugs and Technologies in Health

Version: May 2012

CONCLUSIONS AND IMPLICATIONS FOR DECISION- OR POLICY-MAKING

There is insufficient evidence to draw conclusions on the effects of bevacizumab on mortality, serious morbidity, activities of daily living, and quality of life. Bevacizumab has been shown to improve visual acuity in patients with DME refractory to laser therapy. A clinically significant mean difference was observed in visual acuity of 0.21 ± 0.7 versus sham treatment, which is the equivalent to a two-line (10-letter) gain on the ETDRS scale. In patients who have not yet undergone laser therapy, bevacizumab significantly improved visual acuity versus laser therapy in trials lasting up to one year. The absolute benefit increase ranged from 15% to 19% over six to 52 weeks. However, patients experienced more adverse events on bevacizumab than laser.

RESEARCH QUESTION

In randomized controlled trials (RCTs), does intravitreal injection of bevacizumab provide a therapeutic advantage in the effects on visual acuity, morbidity, and/or mortality in comparison with other standard therapy (intravitreal injection of triamcinolone, pegaptanib, or ranibizumab, or other drug therapies; and laser photocoagulation), sham treatment or placebo in the treatment of diabetic macular edema?

KEY MESSAGES

Although bevacizumab does not have an indication for treatment of diabetic macular edema, there is considerable interest in its use for this condition.

RESULTS

The electronic literature search identified 464 citations, and one additional citation was identified through the search of other sources. From these, 111 duplicates were removed to yield 354 citations for screening. Upon screening titles and abstracts, 342 citations were excluded, and 12 potentially relevant articles were retrieved for full-text review. Of the 12 potentially relevant reports, two reports did not meet the inclusion criteria. Ten publications were included in this review. The study selection process is presented in a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart (Appendix 4).The included and excluded studies are listed in Appendices 5 and , respectively.

DISCUSSION

This systematic review included 10 RCTs testing the effects of bevacizumab in DME: one versus sham injections; five versus laser therapy, and four versus intravitreal triamcinolone (N = 369 eyes on bevacizumab and N = 314 eyes on comparators).

EXECUTIVE SUMMARY

Diabetic retinopathy (DR) and diabetic macular edema (DME) are microvascular complications of diabetes that are a leading cause of blindness in the diabetic population. DME — which is swelling of the retina due to leakage of fluid from blood vessels within the macula, the central portion of the retina — may occur at any time during the progression of DR. The goal of treatment is to preserve current visual acuity and reduce the chances of progression to visual loss. Successful laser treatment reduces moderate visual loss but has limited effects on improving visual acuity. Intravitreal injection of corticosteroids, such as triamcinolone acetate, may also moderately improve visual acuity, but these generally offer only short-term improvements in acuity in cases of DME refractory to laser treatment., Moreover, triamcinolone is not licensed by Health Canada for this indication. Ranibizumab is a recombinant humanized monoclonal immunoglobulin G1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF). It is the only pharmacological therapy licensed in Canada for the treatment of DME.

METHODS

A peer-reviewed literature search was conducted to obtain published literature for this review. The following bibliographic databases were searched: Ovid MEDLINE with In-Process records and daily updates through Ovid (1948 to present), Embase through Ovid (1980 to present), and The Cochrane Library through Wiley. Grey literature (literature that is not commercially published) was identified by a focused Google search. The search strategy consisted of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search concepts were Avastin [intervention] and ocular conditions [indication/population].

CONTEXT AND POLICY ISSUES

Diabetic retinopathy (DR) and diabetic macular edema (DME) are microvascular complications in diabetes that are a leading cause of blindness in this population. DME is swelling of the retina due to leakage of fluid from blood vessels within the macula and may occur at any time during the progression of diabetic retinopathy.

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