The results of a new research conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net), published in the Journal of the American Medical Association have found that that the drug ranibizumab (Lucentis) is highly effective in treating proliferative diabetic retinopathy (PDR), a complication of diabetes that can significantly damage eyesight. This clinical trial funded by the National Eye Institute (NEI) involved 300 patients and demonstrates the first major therapy advance for the condition in nearly 40 years.
Blood vessels in the light sensitive retina in the back of the eye are damaged in PDR and as the condition worsens these blood vessels stop functioning properly. When this condition becomes proliferative, the retina produces a protein called vascular endothelial growth factor (VEGF) that stimulates the growth of abnormal blood vessels. It can induce bleeding in the center of the eye that might need surgical intervention. If PDR is untreated, it can lead to vision loss. As many as 7.7 million U.S. residents have diabetic retinopathy, of which about 1.5 percent cases have progressed to PDR.
Lucentis is among several drugs that block the effects of VEGF. The golden standard for PDR since the mid-1970s has been a laser therapy called panretinal photocoagulation. Even though this laser therapy preserves central vision, it can damage night and side vision, so researchers have been on the lookout for therapies that lack these side effects. The results of the Lucentis injections were compared with the laser therapy and it is found that Lucentis is a safe and effective alternative to laser therapy against PDR.
Lloyd Paul Aiello, M.D., Ph.D., director of the Beetham Eye Institute at Joslin Diabetes Center and Professor of Ophthalmology at Harvard Medical School said that patients who received Lucentis showed a little bit better central vision, much less loss of their side vision, and substantially less risk for surgery than patients who received laser treatment.
For this study the DRCR.net enrolled 305 participants (394 eyes) with PDR in one or both eyes at 55 clinical sites across the country. The participants' eyes were assigned randomly to treatment with Lucentis or laser. About half of the eyes assigned to the laser group required more than one round of laser treatment. In the other group, Lucentis was injected into the eye once per month for three consecutive months, and then as needed until the disease resolved or stabilized.
At two years, vision in the Lucentis group improved by an average of about half a line on an eye chart, compared with virtually no change in the laser group. It was also noted that participants treated with laser generally lost substantial peripheral vision, but those given injections did not. The benefits of anti-VEGF medication were clear. Many of the patients who had laser treatment noticed that they have more tunnel vision, which can lead to difficulties as they go about activities of daily life. The use of anti-VEGF treatment rather than laser for PDR could help prevent these symptoms. Also, the need for vitrectomy surgery was lower in the Lucentis group (8 of 191 eyes) than in the laser group (30 of 203 eyes).
Dr. Aiello noted that the drug’s benefits are particularly clear for people with both PDR and DME diabetic macular edema, a condition when fluid builds up in the center of the retina. Since, it can help treat both conditions at the same time it can be an appealing treatment alternative for patients.
Dr. Aiello also added that in a separate clinical trial they are going to examine whether anti-VEGF injections given at an earlier stage of diabetic eye disease can help prevent people from developing both DME and the sight-threatening PDR stage of the disease.
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