John R. Nordlund, M.D., Ph.D., is the owner of the Williamsburg Retina Center, a full-time practice specializing in diagnosis and treatment of retinal diseases and glaucoma. He is a former University of Virginia School of Medicine faculty member and has fellowship training in both medical retina from the Mayo Clinic and glaucoma from The Johns Hopkins School of Medicine.

Second Opinion by John R. Nordlund, M.D., Ph.D. Published: August 2006 Q: “I suffer from wet macular degeneration, a very serious eye disease. I was told that Lucentis will not only slow the condition, but can also improve vision for some patients. Is Lucentis FDA-approved, and, if so, how does it work? Who is a likely candidate for this drug?” A: Lucentis® (ranibizumab injection) was recently approved by the Food and Drug Administration (FDA) for the treatment of neovascular age-related macular degeneration, commonly known as wet AMD. Wet AMD is a leading cause of blindness among the elderly population. The results that came out of the clinical trials were remarkable. Unlike other treatments, Lucentis prevented moderate vision loss in almost all patients with wet AMD who were treated during a two-year trial period. More promisingly, vision was regained in approximately one-third of the treated eyes. Growth of new blood vessels beneath the retina causes wet AMD. Vascular endothelial growth factor A (VEGF-A) is a hormone responsible, in part, for stimulating growth of new blood vessels (neovascularization). The hormone binds to receptors found on the lining of existing blood vessels. When these receptors are activated, new blood vessels can grow from the existing ones. These new blood vessels leak fluid and blood, causing vision loss. Lucentis is a monoclonal antibody fragment. This manufactured antibody binds to VEGF-A and prevents it from activating the receptors. Since VEGF-A isn’t the only substance that can incite new blood vessel growth, simply blocking this hormone doesn’t stop the process entirely. The results from three clinical trials were submitted to the FDA in support of approving the use of Lucentis for wet AMD. The first study proved that monthly injections of Lucentis for two years prevented vision loss (by at least three lines of vision on the eye chart) among 90 percent of the patients’ eyes tested in that trial. The same trial showed that 33 percent actually regained vision (by at least three lines). A second trial compared monthly injections of Lucentis to quarterly treatments of laser-light therapy, or photodynamic therapy, which uses the medication Visudyne. After one year, the eyes treated with Lucentis gained an average of two lines of vision while those treated with photodynamic therapy lost two. A third study tested the effectiveness of using Lucentis but with fewer doses than the first trial. Patients were treated once a month (for three months), followed by one dose every three months for a total of six injections (compared to an average of 13 injections used in the first trial). This method proved 90 percent effective in helping patients maintain the vision they had in the affected eye at the start of the study; however, this method did not lead to improved vision. Despite its success in clinical trials, Lucentis has its down side. The drug must be injected into the back of the eye. While the injection isn’t painful, some patients are frightened by the idea. Antibiotics and antiseptic agents must be administered prior to injection to minimize the risk of infection (endophthalmitis). The treated eye should be examined for infection, inflammation, retinal tear, retinal detachment or other complications within a week after the injection. Common side effects are mild eye pain, “floaters,” and increased eye pressure, which are temporary and usually don’t require treatment. Lucentis is expensive, averaging $2,000 per injection (medication only). Most insurance companies and Medicare have agreed to help pay for the drug, yet they may not cover the entire cost. Genentech, the manufacturer, has agreed to assist patients who meet certain requirements to pay off the remaining balance. Does this mean that all patients with wet AMD should be treated with Lucentis? Probably not. Other techniques for treating wet AMD have shown merit. Most retinal specialists believe that a combination of existing treatments will be more effective than any single medication. Effectiveness of treatments will vary from patient to patient. Clinical examinations and diagnostic tests such as Optical Coherence Tomography (OCT), which uses light to study the layers of the retina, and fluorescein angiography (a study of the blood flow within the retina) can help retinal specialists determine the best treatment method for each patient. Patients with AMD can minimize their risk of significant vision loss by checking their central vision in each eye daily. If their vision is distorted or there is a loss of clarity, they should notify their eye doctor immediately. Early treatment of wet AMD is essential for a better outcome.

Williamsburg Health Journal 4808 Courthouse Street, Suite 204 Williamsburg, VA 23188 757-645-4475 © 2007 RIAN ENTERPRISES, LLC