Who is the sponsor?
Bausch & Lomb /Control Delivery Systems( Now pSividia)
Who are the patients?
Males and non-pregnant females at least eighteen years of age with diabetic macular edema.
How long is the trial?
When did participation agreement start at our site?
August 20, 2001
What is the enrollment goal for the sponsor?
One hundred and eighty nationwide.
Is the enrollment still open?
No. This study is now closed.
What is this study investigating?
This is a multicenter, randomized, masked, controlled study to evaluate the safety and efficacy of RetisertTM, an intravitreal fluocinolone acetonide implant, in the treatment of patients with diabetic macular edema (DME). Patients who qualify for enrollment are randomly assigned one of the following surgeries to one eye: 1.) RetisertTM implant alone. 2.) Retisert implant and a vitrectomy. 3.) Placebo implant and a vitrectomy
How is the treatment administered?
The Retisert implant is inserted into the eye through a minor surgical procedure called a vitrectomy.