INTRAVITREAL FLUOCINOLONE IMPLANT MACULAR DEGENERATION

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The broad long-term goal of this research is to reduce or eliminate blindness due to choroidal neovascular membrane formation (CNVM) in Age-Related Macular Degeneration (ARMD). Up to 87 percent of eyes with CRNV present with "ill-defined" lesions. No beneficial treatment for this form of choroidal neovascularization has been established. Histopathologic study has demonstrated the presence of inflammatory and reparative responses in the retina of these patients. Since corticosteroids have been shown to down-regulate many of the cellular factors involved in both inflammation and repair, the present study is designed to assess the efficacy of a sustained release intravitreal corticosteroid implant. This implant has been extensively studied in animals and is presently in Phase I human studies for uveitis and recurrent sub-macular membranes in histoplasmosis. The clinical protocols will be carried out in the Clinical Trials Branch of the National Eye Institute. Phase 1 of this protocol will establish the feasibility and safety of this treatment in 40 patients. Phase II of this fast-track proposal is designed to determine efficacy. This proposal requests funding to provide the laboratory work required to support these clinical trials. The investigators at CDS invented and were responsible for the development of the Vitrasert ganciclovir device: the only FDA approved intraocular drug delivery system. PROPOSED COMMERCIAL APPLICATION The successful completion of this work could be followed by the approval of the first pharmacological therapy for ARMD. The potential commercial applications are therefore immense. CDS is fully committed to this project and royalties from sale of the Vitrasert allow us to commit internal funds to insure success of phase 3 of this work. We are actively negotiating with a major ophthalmic pharmaceutical company to ensure successful commercialization.