Diabetic Macular Edema Study
Monthly Ranibizumab versus Treat and Extend Ranibizumab for Diabetic Macular Edema
In our ongoing effort to care for our community and help the progress of ophthalmology, it is my honor to inform you that Retina Vitreous Associates of Florida has activated a prospective controlled clinical trial for diabetic macular edema.
Our trial, “Monthly Ranibizumab versus Treat and Extend Ranibizumab for Diabetic Macular Edema,” is the only diabetic macular edema trial actively recruiting in the Tampa Bay area. It is registered with the United States National Institutes of Health on www.ClinicalTrials.gov and has oversight from an independent Institutional Review Board.
Our protocol is a dosing study of ranibizumab (Lucentis) in diabetic macular edema. Every patient enrolled in the study will receive treatment with Lucentis. Our trial compares a group of patients receiving monthly Lucentis for diabetic macular edema with a group of patients receiving Lucentis in a treat-and-extend fashion. The goal of the study is to see if there is a meaningful difference in visual acuity and macular structure with these two different dosing methodologies.
Study drug is being supplied by Genentech, and the study is supported by Genentech such that there will be no charge to the subject patients for study visits. Lucentis has been previously been studied on a monthly basis in diabetic macular edema in the RISE/RIDE trials. The results of these prior studies reported in 2011 demonstrated remarkable efficacy of Lucentis in diabetic macular edema when compared to traditional laser photocoagulation. With those results known, you can consider being screened for our dosing study with the peace of mind that you will be receiving the most modern and effective therapy available for diabetic macular edema.
Lucentis has been approved for wet AMD since 2006 and for retinal vascular occlusion since 2010. Its use in diabetic macular edema is investigational, so this trial is a unique opportunity for you to receive this biologic for your diabetic eye disease.
As Principal Investigator, I am eager to talk with you about how this trial may benefit you and the future of retinal care. Feel free to call me directly with any questions.
My Best Regards,
