Abdhish R. Bhavsar, MD (Minneapolis, MN),* Maurice B. Landers, MD, FACS (Chapel Hill, NC),* Ronald K. Pearson, PhD (Harrisburg, PA),* Alan M. Hochberg, BSE (Harrisburg, PA),* Timothy R. McNamara, Pharm D (Irvine, CA),* James A. Gow, MD (Irvine, CA),* Lisa R. Grillone, PhD (Irvine, CA)*


To develop and validate a method of predicting by one month post-intravitreous injection whether subjects receiving Vitrase® (lyophilized, ovine hyaluronidase for injection), will receive adequate laser photocoagulation without vitrectomy by three months post-injection.


A statistical training set drawn from subjects with diabetes mellitus (N=350 of 813) from the Vitrase for Vitreous Hemorrhage phase III clinical trials was retrospectively analyzed. At baseline and at 1 month post-injection, vitreous hemorrhage density was scored on a welldefined 0-4 scale, in each of 12 radial segments within the eye (“clock hours”). Using receiveroperating-characteristic (ROC) analysis, the change in the sum of the 12 scores (“Total Hemorrhage Point Score,” THPS) was evaluated as a predictor of treatment success, defined as completion of panretinal laser photocoagulation (PRP) by 3 months without vitrectomy. THPS was compared for saline, 55 IU and 75 IU Vitrase groups.


For the ROC analysis, the area under the curve was 0.865 (p <0.0001), indicating high predictive value. Subjects in the 55 IU and 75 IU Vitrase treatment groups had considerably greater median improvement in THPS at one month compared to saline (8.0 and 6.0 vs 2.0, p<0.0001 and p=0.0003, respectively by the one-sided Wilcoxon rank-sum test), with corresponding trends in completion of laser among the three groups.


The change in a measure of the density of vitreous hemorrhage, THPS, by 1 month postintravitreous injection of Vitrase, allows prediction of treatment success, based on the amount of PRP completed by 3 months. Subjects with diabetes who were treated with Vitrase had significantly higher predicted success rates than subjects treated with saline. This can allow more effective management of VH.
* Financial interest disclosed