Retina Health Center is now accepting patients for a clinical trial for a new pill, X-82, for the treatment of wet age-related macular degeneration (AMD). Current treatments for wet AMD include three drugs that are injected into the eye that stop the growth of blood vessels, targeting VEGF, a growth factor that contributes to new blood vessels. Research has suggested that an additional growth factor, PDGF, is also active in wet AMD, and the new pill X-82 targets both VEGF and PDGF and may reduce or replace the need for intraocular injections..
A phase-1 trial has been completed and 15 of the 25 participating patients who completed 6 months of treatment gained more than five letters on the eye chart. Retina Health Center is one of 30 clinical trial sites around the U.S. for the phase-2 study.
Tyrogenex, the company that developed X-82, is conducting a randomized, double-masked, placebo-controlled, dose-finding phase-2 study and expects to enroll at least 132 patients. Patients with wet AMD previously treated with Avastin, Lucentis or Eylea will be considered for the trial. The study is designed to evaluate the safety and efficacy of X-82, a pill, in the prevention of vision loss due to wet AMD. The study will measure the mean change in visual acuity score from day one to 52 weeks after randomization. Another key endpoint is the reduction of the number of injections needed for the duration of the study.
AMD is the leading cause of blindness for people over the age of 50 in the United States and Europe. There are two forms of the disease, namely “dry” and “wet” AMD. Wet AMD is characterized by the growth of new blood vessels into the central region of the retina. These new and abnormal blood vessels cause severe central vision loss due to retinal damage caused by leakage of the blood vessels and subsequent scar formation.
Retina Health Center and the Macular Degeneration Research Center were established in 2002 by Dr. Alexander M. Eaton, a long-time Southwest Florida resident, who has been practicing ophthalmology in Lee and Collier counties for more than 20 years. Dr. Eaton has been the principal investigator for numerous studies to prevent and treat macular degeneration, and has invented numerous medical devices for use by patients and physicians that are used worldwide. For more information on the latest studies or to make an appointment, call 239-337-3337 in Fort Myers or 239-793-5200 in Naples, or visit www.retinahealthcenter.com.