NIH TO FUND STUDY OF AMD TREATMENTS

The National Eye Institute (NEI) of the NIH will fund a multicenter clinical trial to compare two drugs currently used to treat advanced age-related macular degeneration (AMD). The two drugs are Lucentis (ranibizumab) and Avastin (bevacizumab), both made by Genentech.

Lucentis was approved by the FDA earlier this year. The approval was based on evidence from clinical trials showing that Lucentis slows the rate of progression of vision loss from advanced AMD. In addition to a low rate of developing vision loss, approximately one-third of patients treated in these trials had improved vision at 12 months. Avastin, which is related to Lucentis, has been approved by FDA for treating colorectal cancer, but not specifically for ophthalmic uses. However, Avastin has been widely used off-label to treat advanced AMD. The new comparative study will assess the relative safety and effectiveness of Avastin and Lucentis.

Angiogenesis is a term used to describe the growth of new blood vessels. Inhibition of angiogenesis as a possible treatment for advanced age-related macular degeneration is an extremely active area of research and drug development. Over the past several decades, the NEI has provided approximately $570 million for more than 1,900 research project grants designed to improve our understanding of the role of angiogenesis in major causes of blindness and visual disability.

In advanced AMD, abnormal new blood vessels grow beneath the retina. These abnormal blood vessels can leak blood and fluid, and can cause severe vision loss. NEI-supported research has helped establish that vascular endothelial growth factor (VEGF) is an important part of the biological pathways involved in triggering and sustaining the growth of new blood vessels in the retina. Research also demonstrated that VEGF is present in higher levels in a number of eye diseases, such as AMD.