May 13, 2005

Treatment helps limit AMD’s march

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Paul Sternberg, M.D.

Treatment helps limit AMD’s march

Ophthalmologists at Vanderbilt University Medical Center are employing a new treatment in the fight against neovascular (wet) age-related macular degeneration (AMD), an eye disease associated with aging that destroys central vision.

In December 2004, Eyetech Pharmaceuticals Inc. and Pfizer Inc. announced that the Food and Drug Administration (FDA) approved macugen (pegaptanib sodium injection) for the treatment of AMD, which is the leading cause of irreversible severe vision loss in patients older than 50. Macugen helps preserve vision and helps limit progression to legal blindness.

“The drug is one of the first to incorporate anti-angiogenic therapy where they are blocking a molecule called Vascular Endothelial Growth Factor (VEGF) that is an important factor in abnormal blood vessel growth. Macugen directly binds to and inhibits VEGF at the site of its release,” said Paul Sternberg, M.D., George W. Hale Professor of Ophthalmology and Visual Sciences and chair of the department. Sternberg is one of the first doctors to administer Macugen in his office.

“When I was at Emory, I was an investigator in the Phase 1 trial where we treated the first patients with this drug,” said Sternberg. “Two multi-center collaborative international trials showed that it prevented severe vision loss from wet macular degeneration. Unfortunately, less than 10 percent had significant improvement in vision, but it was superior to conventional treatments in stabilizing vision loss.”

Other medications for AMD have been administered either intravenously, orally or by injection around the eye. Macugen, however, is injected directly into the eye in a minimally painful procedure that patients seem to tolerate.

Sternberg and his colleagues in the Department of Ophthalmology have now treated more than 10 patients with macugen. “In all cases, the initial injection has been uncomplicated and most of the patients were impressed with how smoothly the treatment proceeded with truly minimal discomfort,” said Sternberg.

The treatment requires a series of nine injections at six-week intervals over a 12-month time period. “Like with chemotherapy for cancer, it takes several treatments over several months for us to be able to determine whether or not the eye is responding, so we won't know how our initial patients have responded to treatment for quite awhile,” Sternberg explained.

Overall, macugen represents a new approach to the treatment of wet age-related macular degeneration. It is safe, well-tolerated and has been demonstrated to reduce moderate vision loss (30 percent pegatanib vs. 55 percent for placebo). Unfortunately, only 33 percent of treated patients will maintain their current level of vision (vs. 23 percent with placebo) and only 6 percent will have moderate gain in vision (vs. 2 percent for placebo).

“We will continue to participate in research programs to evaluate potentially more effective treatments,” Sternberg said. “These include the use of combination therapy as in the VERTCL study, where we are evaluating the benefit of visudyne (VERteporfin) photodynamic therapy combined with intraocular steroid injections (TriamCinoLone), and the AART Study, where we are studying the use of Anecortave Acetate to prevent progression to wet AMD, in a risk reduction trial.”