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Current Trials for Vitreosolve® for Diabetic Retinopathy Vitreosolve® is being studied in two Phase III trials conducted in multiple sites in the United States, India and Mexico. PVD-301 Study The objective of the PVD-301 study is to evaluate the safety and efficacy of Vitreosolve® ophthalmic intravitreal injection in patients with nonproliferative diabetic retinopathy (NPDR), a medical condition which affects the health of the eyes resulting in bleeding, inappropriate blood vessel growth, and severe vision loss or blindness. Vitreosolve® is used for inducing a posterior vitreous detachment (PVD) in these patients to prevent the loss of vision. This is a prospective, randomized, double-masked, placebo-controlled study. Approximately 400 patients with NPDR in the United States and India will be enrolled and randomized into one of two study groups: active study group or control group. The duration of the study is approximately seven months. PVD-302 Study The objective of the second clinical trial, PVD-302, is to evaluate the safety and efficacy of Vitreosolve® ophthalmic intravitreal injection in patients who have nonproliferative diabetic retinopathy (NPDR), a medical condition which affects the health of your eyes resulting in bleeding, inappropriate blood vessel growth, and severe vision loss or blindness. Vitreosolve® is used for inducing a posterior vitreous detachment (PVD) in these patients to prevent the loss of vision. This is a prospective, randomized, double-masked, placebo-controlled study. Approximately 150 patients with NPDR in Mexico will be enrolled and randomized into one of two study groups: active study group or control group. The duration of the study is approximately five months. Sites in the United States, India and Mexico are actively recruiting subjects. |
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For More Information If you are interested in learning more about this study and at what clinics the study is being conducted please contact Vitreoretinal Technologies, Inc at 1-877-4PVD-301. This study also is listed as NCT00664183 on the clinical trials.gov website: For more information on Diabetic Retinopathy: A DVD titled “Understanding Diabetic Retinopathy is offered by the American Academy of Ophthalmology. This DVD explains nonproliferative (NPDR) and proliferative (PDR) diabetic retinopathy from both the physician's and patient's perspectives. For more information on diabetes: |
