Who is the sponsor?
SurModics
Who are the patients?
Male or female eighteen years of age and older who have macular edema associated with diabetic retinopathy, not responding to laser treatment after at least 90 days.
How long is the trial?
Patients were monitored for three years.
What is the enrollment goal for the sponsor?
30 patients
Is the enrollment still open?
No. This study is now closed.
What is this study investigating?
This is a phase 1, multicenter, randomized, double-masked study with the following objective: To evaluate the safety, tolerability and duration of effect of a helical intravitreal triamcinolone implant for the treatment of diabetic macular edema.
The implant is designed to replace multiple injections (the current method for intravitreous drug delivery) with a single implant providing long-term, controlled drug release which could represent a significant advance in therapeutic treatment, including improved patient compliance, reduced side effects and greater efficacy.
How is the treatment administered?
Study patients are randomly assigned to one of two formulations of the helical intravitreal triacinolone implant which is surgically implanted.