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Clinical Trial Network Demonstrates Comparative Effectiveness of Lucentis for Reversing Some Vision Loss Caused by Diabetes

Background:

Diabetic retinopathy is a leading cause of blindness in the U.S. The condition results from the growth of abnormal blood vessels in the back of the eye that leak fluid and serum in to the retina. As a result, the retina swells, damaging photoreceptor cells. If left untreated, diabetic retinopathy can cause severe visual impairment and blindness. For the past 25 years, diabetic retinopathy has been treated with a laser to destroy abnormal blood vessels. Although laser therapy slows disease progression, the effects are temporary, and repeated treatments can damage healthy retinal tissue and impair vision. National Eye Institute (NEI) investigators have been working to improve treatment and preserve vision. The NEI and the National Institute of Diabetes and Digestive and Kidney Diseases started the Diabetic Retinopathy Clinical Research Network (DRCR.net) to find more effective treatments for diabetic eye disease. DRCR.net is a collaborative clinical trial network involving both academic centers and community ophthalmic practices.

Results:

Evidence has accumulated that abnormal blood vessel growth in diabetic retinopathy is caused by a protein, vascular endothelial growth factor (VEGF). This trial compared the effectiveness of laser therapy alone to laser therapy combined with Lucentis, a drug that prevents VEGF from stimulating abnormal blood vessel growth. The study involved 690 patients at 52 clinical sites within the DRCR.net. Nearly 50 percent of patients who received the combination of Lucentis and laser treatment experienced substantial visual improvement after one year, compared with only 28 percent who received laser treatment alone.

Public Impact Statement/Significance:

This treatment represents a dramatic breakthrough as it is the first therapy for diabetic retinopathy that improves vision.

Lucentis is currently FDA-approved for treating age-related macular degeneration which is also caused by leaky, abnormal blood vessels, Although the use of Lucentis for diabetic retinopathy is currently off-label, the results of this trial are already changing clinical practice. Moreover, the DRCR.net is a model network for rapidly developing and implementing large, multi-center clinical trials.

Grant Support:

EY14231, EY14229, and EY018817.

Publication Citation:

The Diabetic Retinopathy Clinical Research Network. Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema. Ophthalmology. 2010 Apr 22. [Epub ahead of print]. PubMed

Last Reviewed: May 2010



Department of Health and Human Services NIH, the National Institutes of Health USA.gov