LAS VEGAS, Nov. 15 /PRNewswire-FirstCall/ -- A combined analysis of two landmark clinical glaucoma trials -- the Ocular Hypertension Treatment Study (OHTS) and the European Glaucoma Prevention Study (EGPS) -- confirms the benefit of a five-year risk assessment model to help ophthalmologists better predict which patients have an increased risk of developing glaucoma. Glaucoma is the second leading cause of blindness in the world, affecting approximately 70 million people, and can lead to blindness if left untreated. These new data were presented this week at the annual American Academy of Ophthalmology meeting.
The analysis showed that patients with elevated intraocular pressure (IOP) -- along with other predictive risk factors, such as older age (40+) -- are at highest risk of progressing to primary open-angle glaucoma (POAG). The results are similar to the 2005 risk-assessment model reported by Dr. Robert N. Weinreb and Dr. Felipe A. Medeiros based on findings from the 2002 Ocular Hypertension Treatment Study (OHTS), a five-year National Eye Institute- sponsored trial that found early intervention with IOP-lowering medications could prevent glaucoma in at-risk patients.
“It is critical to continue to evaluate and refine innovative, predictive models in ophthalmic medicine in order to provide the best treatment possible for patients,” said Dr. Michael Kass. “We hope this tool will become as universally adapted as predictive models used in other therapeutic areas, such as the Framingham Study, which provided a basis for accurate cardiac risk assessment.”
“For some time we have known that if we could identify those patients most likely to progress to glaucoma, earlier intervention with effective treatments could help reduce the risk of vision impairment,” said Dr. Robert N. Weinreb, director of the Hamilton Glaucoma Center and Distinguished Professor of Ophthalmology at the University of California, San Diego, USA. “This new analysis provides a larger-scale validation of breakthrough findings of the OHTS group and reinforces to clinicians how the tool can be useful in assessing which patients are most at risk.”
The OHTS prediction model was tested on patients in the EGPS placebo group and the two study samples from the control (non-treated) arms were pooled to increase precision and generalizability of a five-year predictive model for developing POAG. The OHTS observation group contained 819 patients with a median follow up of every six months for 6.6 years. The EGPS placebo group contained 500 patients with a median follow up of every six months for 4.8 years.
“We know that awareness of these predictors, particularly elevated intraocular pressure, and central corneal thickness, is critical in treating and potentially preventing damage to the optic nerve caused by glaucoma progression,” said Professor Stefano Miglior, director of the Department of Ophthalmology, Policlinico di Monza, University of Milan Bicocca, Italy, and Chairman of EGPS. “The large-scale validation, which includes a European patient population for the first time, reinforces the consensus about the importance of informed dialogue between physicians and patients on how often eye examinations are needed and when it might be appropriate to initiate treatment.”
The research was supported by grants from Pfizer Inc, the National Eye Institute and the National Center for Minority Health and Health Disparities, National Institutes of Health, the European Commission and Research to Prevent Blindness and Merck Research Laboratories.
Pfizer’s current product line includes the most prescribed treatment to lower elevated eye pressure in patients with ocular hypertension (abnormally high eye pressure) or open-angle glaucoma. In collaboration with (OSI) Eyetech, the division also includes a treatment for neovascular age-related macular degeneration.
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