INTRAVITREAL FLUOCINOLONE IMPLANT MACULAR DEGENERATION

本研究的长期目标是减少或消除年龄相关性黄斑变性（ARMD）中脉络膜新生血管膜形成（CNVM）引起的失明。高达87%的CRNV眼睛存在“界限不清”的病变。对于这种形式的脉络膜新生血管没有有效的治疗方法。组织病理学研究表明，这些患者的视网膜存在炎症和修复反应。由于皮质类固醇已被证明可以下调许多参与炎症和修复的细胞因子，本研究旨在评估玻璃体内持续释放皮质类固醇植入物的疗效。这种植入物已经在动物身上进行了广泛的研究，目前正在进行一期人体研究，用于治疗组织胞浆菌病中的葡萄膜炎和复发性黄斑下膜。临床方案将在国家眼科研究所临床试验处实施。该方案的第一阶段将在40名患者中确定这种治疗的可行性和安全性。该快速通道提案的第二阶段旨在确定疗效。本提案要求为支持这些临床试验所需的实验室工作提供资金。CDS的研究人员发明并负责开发了Vitrasert更昔洛韦装置：FDA批准的唯一一种眼内给药系统。这项工作的成功完成之后，可能会批准首个用于ARMD的药物治疗。因此，潜在的商业应用是巨大的。CDS完全致力于这个项目，出售Vitrasert的特许权使用费使我们能够投入内部资金，以确保这项工作的第三阶段成功。我们正在与一家大型眼科制药公司积极谈判，以确保成功商业化。

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.