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Lupus Clinical Trials

New Medical Therapies™

Diabetic Vitreous Hemorrhage

April 1, 2002

Preliminary results of two phase III trials of Vitrase (hyaluronidase) did not show a statistically significant clearance of vitreous hemorrhage, the primary endpoint. However, statistically significant improvements in best-corrected visual acuity (BCVA) and vitreous hemorrhage density were demonstrated in both trials. A total of 1,306 subjects with severe vitreous hemorrhage whose visual acuity was worse than 20/200 were enrolled in the two randomized, double-masked, placebo-controlled international studies. In both trials, at one-month and two-month visits after a 55 IU Vitrase injection, statistically significant improvement in BCVA was observed. In one trial, this clinically relevant improvement extended to the three-month post-treatment visit for subjects receiving the 55 IU injection of Vitrase. In addition, significant decrease in vitreous hemorrhage density was seen at one, two, and three-month post-treatment visits. Vitrase is being developed by Ista Pharmaceuticals.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.