Determine the Safety and Efficacy of Vitreosolve® Administered Intravitreally to Induce a Complete Posterior Vitreous Detachment (PVD) in Non Proliferative Diabetic Retinopathy Human Subjects

Abstract

Abstract: : Purpose:To evaluate the safety and efficacy of Vitreosolve® administered intravitreally to induce a complete posterior vitreous detachment (PVD) in non proliferative diabetic retinopathy human subjects. Materials and Methods: 20 subjects received a 100µl intravitreal injection of 12.0mg/100 µl of Vitreosolve®, for Ophthalmic Intravitreal Injection. The subjects were observed at baseline, day of 1^st injection, days 1, 7, 15, 30, and a second injection at day 30 with follow–up visits at days 45, and 60. The safety and efficacy of Vitreosolve was determined by clinical examination Fundus Photography, ß–scan and fluorescein angiography. Subjects were considered to have a Total PVD when confirmed by both clinical evaluation as well as ß– scan Ultrasonography. Results: There was no significant difference in reported adverse effects between the various time points in the Vitreosolve® injected subjects. Slit lamp Biomicroscopy, Indirect Ophthalmoscopy and ß–scan were the three indicators for the induction of Posterior Vitreous Detachment. The slit lamp fundus evaluation with a 78 D lens were carried out at each time point to evaluate any changes in vitreous density, attachment, or possible hemorrhage. ß–scan was also carried out at baseline, 1 day, 7 days, 15 days, 30 days, post first injection as well as 45 days, 60 days post second injection to help determine the incidence of vitreous collapse. Patients were considered to have a vitreous collapse when confirmed by both clinical evaluation as well as ß–scan ultrasonography. Overall, Vitreosolve^® intravitreal injection resulted in 45% total PVDs with the first injection and 75% total PVDs with the second injection. If one considers the total number of PVDs to include partial PVDs the number rises to 94% of the patients having PVD. Conclusions: We conclude that Vitreosolve, for Ophthalmic Intravitreal Injection was safe and effective in inducing posterior Vitreous detachment when injected in Non Proliferative Diabetic Retinopathy Subjects.

Keywords: diabetic retinopathy