By Jennifer Bonck

The implant is a tiny drug reservoir implanted into the back of the eye. It uses technology developed by Pearson and his colleagues, Envision TD, to enable the delivery of sustained and consistent levels of drug directly to the affected area of the eye for up to three years.

Lexington, Ky. (Nov. 19, 2002) -- Diabetes is often termed a silent killer. One silent, possible complication of the disease is blindness. The results of a multi-center study led by the University of Kentucky Department of Ophthalmology offer hope in combating this devastating aspect of diabetes.

Andrew Pearson, M.D., associate professor and chair, Department of Ophthalmology, UK College of Medicine, is investigating the safety and effectiveness of an ophthalmic implant for the treatment of diabetic macular edema (DME), a condition that occurs when damaged blood vessels leak and cause blurring of central vision.

The implant is a tiny drug reservoir implanted into the back of the eye. It uses technology developed by Pearson and his colleagues, Envision TD, to enable the delivery of sustained and consistent levels of drug directly to the affected area of the eye for up to three years.

In this controlled and masked clinical trial, 80 patients were randomized to receive standard of care (currently available treatment) or drug implant. After six months of treatment, patients were evaluated for changes in DME. Patients receiving the implant showed a statistically significant improvement in DME and a greater improvement in the severity of their diabetic retinopathy compared to those receiving standard of care. Further, eighty percent of patients receiving the implant had improved or stable visual acuity, compared to fifty percent of those treated with standard of care.

The patients will be followed for an additional 3.5 years to continue to monitor the safety of the implant over time. Pearson, the lead investigator of the study, presented the six-month results at the 2002 Retina Congress this past September.
The promising findings of earlier, related studies have warranted a fast track designation for the implant from the Food and Drug Administration (FDA). The data from this trial, together with the results of a second, ongoing study, will serve as the basis for a new drug application to be filed with the FDA as early as next year.

This news is most welcome to patients suffering from DME. Sandra Sparkman, Pippa Passes, Ky., has experienced a vast improvement in her vision as a result of the treatment. Her visual acuity has improved by 30 letters. "My vision is so much better now, and I am so grateful for the study," she said.

Sparkman is one of the millions worldwide afflicted with DME. Current treatments are limited and can generally only slow disease progression. There is a great need for more effective treatment options; the results of this study bring us one step closer to fulfilling that need, and eradicating blinding complications of diabetes.