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Clinical Trial Evaluates Ranibizumab for Vitreous Hemorrhage

EMBARGOED FOR RELEASE: 3 P.M. (CT), THURSDAY, JANUARY 31, 2013

 

JAMA Ophthalmology Study Highlights

Clinical Trial Evaluates Ranibizumab for Vitreous Hemorrhage

The Diabetic Retinopathy Clinical Research Network conducted a phase 3 double-masked, randomized, multi-center clinical trial to evaluate eye injections of ranibizumab compared with saline on vitrectomy (a surgical procedure to remove the jellylike liquid in the eye) rates for vitreous hemorrhage from proliferative diabetic retinopathy.

 

The study included 261 eyes of 261 study participants who were at least 18 years old with type 1 or type 2 diabetes mellitus. Eyes were assigned to receive 0.5 mg intravitreal (eye injection) ranibizumab (n=125) or intravitreal saline (n=136) at baseline and four and eight weeks.

 

“Overall, the 16-week vitrectomy rates were lower than expected in both groups. This study suggests little likelihood of a clinically important difference between ranibizumab and saline on the rate of vitrectomy by 16 weeks in eyes with vitreous hemorrhage from PDR,” the study concludes. (Online First)

(JAMA Ophthalmol. Published online January 31, 2013. doi:10.1001/jamaophthalmol.2013.2015. Available pre-embargo to the media at http://media.jamanetwork.com.)

 

Editor’s Note: Genentech provided the ranibizumab for the study and provided funds to defray the study’s clinical site costs. The work was supported though cooperative agreements from the National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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