Clarity Medical Systems, Inc.
Clinical trials currently underway to determine whether Anti-VEGF therapy improves structural outcomes and reduces incidence of blindness in ROP
Pleasanton, CA -August 03, 2009 -- Clarity Medical Systems, Inc. today announced that two clinical trials are currently enrolling for the treatment of Retinopathy of Prematurity (ROP) where the RetCam Digital Imaging System is a requirement for participation. The studies, Pan-VEGF Blockade for the Treatment of Retinopathy of Prematurity (BLOCK-ROP) and Bevacizumab Eliminates the Angiogenic Threat of Retinopathy of Prematurity (BEAT-ROP) have shown promise to potentially change the standard for treatment of ROP. The RetCam is being used as a vital tool in these studies for imaging and photo documentation during the course of treatment and follow up exams. This visual record will help investigators evaluate the drug therapy.
The purpose of BLOCK-ROP is to evaluate the safety of Bevacizumab (Avastin) administered in a single dose into the vitreous cavity and to determine the efficacy of treatment for improving structural outcome without surgical intervention after failed standard laser treatment. The purpose of BEAT-ROP is to determine whether injections into the vitreous of an anti-vascular endothelial growth factor (VEGF) will reduce the incidence of blindness by suppressing the neovascular phase of ROP compared to a control group receiving conventional laser therapy and to determine the safety and efficacy of intravitreal bevacizumab in the treatment of ROP.
“The documentation in this clinical trial is being done with the RetCam, whereas previous studies have been done using retinal drawings. This method provides reliable documentation which has proved to be vital in clinical trials assessing ROP,” comments Michael Trese, MD, Vision Research Foundation, and Primary Investigator for BLOCK-ROP clinical trials. “Retinal drawings are potentially less accurate than a photograph, where photographs prove to be both intuitive and objective. The wide-angle view allows you to get pictures of the peripheries and provides objective evidence and results. It really provides a better ability to see what is going on, and I feel that this documentation is an important part of the clinical trial.”
Helen Mintz-Hittner, M.D., The University of Texas Health Science Center-Houston and Primary Investigator of the BEAT-ROP multi-center clinical trial states, "In our clinical trial, we require a pre- and post- treatment RetCam evaluation, both in those treated by Laser and in those treated by Avastin." She continues, "In this study, we also use the RetCam to obtain fluorescein angiograms to show either the loss of vessels in the peripheral retina following Laser treatment, or the continued growth of vessels into the peripheral retina following Avastin treatment. This really proves to be invaluable. I truly feel that no study should be undertaken without this objective form of photographic documentation."
The RetCam is the only ophthalmic camera designed for imaging infants and small children. With approximately 700 systems installed in 59 countries, the RetCam enables photo documentation of the structure of the retina, allowing evaluation prior to, during and post treatment. Many Level II and III hospital NICUs offer RetCam imaging as part of their advanced neonatal care services.
A sampling of the thirty-one enrolling sites for both clinical trials include: Bascom-Palmer Eye Institute, Baylor College of Medicine, California Vitreoretinal Center, Driscoll Children’s Hospital, UCLA Jules Stein Eye Institute, and the University of Pennsylvania Scheie Eye Institute. A full list of enrolling sites is available at www.clinicaltrials.gov.
About Clarity Medical Systems, Inc.
Clarity Medical Systems, Inc. is a medical device company that develops, manufactures and markets integrated optical systems and services. These patented devices combine innovative 21st century optical, electronic and information technologies that change the very nature of eye healthcare. The Company's initial product line has improved the standard of eye healthcare for pediatrics and is sold to leading Neonatal Intensive Care Units on a global basis.
The Company's first product line, the RetCam, is a major achievement in providing minaturized, integrated, wide-field imaging for eye disorders in infants and children. The RetCam has revolutionized imaging and photo documentation for the pediatric population and has been the enabling tool for several international clinical trials.
About ROP
Retinopathy of Prematurity (ROP) is a leading cause of blindness in children in developed countries around the world, and an increasing cause of blindness in developing countries. The retina lines the inside of the eye. It functions as "film" within the camera which is the eye. When an infant is born prematurely, the vascular network necessary to nourish the retina has not fully developed. As a consequence, in some infants abnormal vessels grow instead of the normal ones - a condition known as ROP. The abnormal vessel growth may lead to retinal detachment and blindness if the eye is not treated.
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