Georgia Retina Completes Phase III Clinical Trial on Drug for Diabetic Macular Edema
Patients in Clinical Trial Showed Improvements In their Vision after 24 Months
Georgia Retina, the state’s largest retina-only private practice, joins drug manufacturer Genentech in announcing the successful completion of a Phase III clinical trial on a drug to treat patients with diabetic macular edema (DME).
Dr. Mark J. Rivellese, the principal investigator at Georgia Retina for the trial, said the study met the primary endpoint and showed improved vision in patients receiving the drug.
“Patients with DME who received Lucentis were more likely to achieve a significant improvement in vision after 24 months than the control group,” he said.
DME is a serious complication of diabetes that affects up to 10 percent of people with the disease and can lead to blurred vision, severe vision loss, and blindness.
The study, known as RISE, showed that a significantly higher percentage of patients receiving monthly Lucentis achieved an improvement in vision (BCVA) of at least 15 letters on the eye chart at 24 months, compared to those in a control group, who received a placebo (sham) injection. BCVA is best-corrected visual acuity, the best possible vision a person can achieve with corrective lenses, as measured by reading the eye chart. A preliminary analysis of the data did not reveal any unexpected safety signals and further analyses are ongoing.
Top line results from the RISE study were presented at the 34th Annual Macula Society Meeting on March 10, 2011 in Boca Raton, Florida, Dr. Rivellese said.
Georgia Retina participates in multiple National Eye Institute and clinical trials each year.
Dr. Robert A. Stoltz is clinical trial director for Georgia Retina. He has actively participated in numerous clinical trials pertaining to ophthalmology, including his role as Principal Investigator of the Photograph Reading Center involved with the Complications of Age-Related Macular Degeneration Prevention Trial. Dr. Stoltz is a Fellow of the American Academy of Ophthalmology and the College of Physicians of Philadelphia.
Dr. Stoltz and Dr. Rivellese are each board-certified ophthalmologists.
Dr. Rivellese has participated in multiple clinical trials for the investigation of macular degeneration, retinal vascular disease, and retinopathy of prematurity.
For more information on the clinical trials underway at Georgia Retina, go to www.garetina.com.
At Georgia Retina, patients’ vision needs are the top priority. As one of the largest retina-only medical practices in the southeastern United States, Georgia Retina specializes in treating diseases of the retina, macula, and vitreous. Its nine board-certified ophthalmologists have received special Fellowship training in vitreo-retinal diseases and surgery, and are engaged in clinical trials with the goal of advancing research into retinal diseases, their causes, and their cures.
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