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.
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
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
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