INTRAVITREAL FLUOCINOLONE IMPLANT MACULAR DEGENERATION

玻璃体内氟轻松植入物治疗黄斑变性

• 批准号: 6015306
• 负责人: PAUL ASHTON
• 金额: $ 9.89万
• 依托单位: CONTROL DELIVERY SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2000-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6015306
• 关键词: angiogenesis; biomedical equipment development; corticosteroids; drug delivery systems; drug design /synthesis /production; eye disorder chemotherapy; high performance liquid chromatography; macular degeneration; pregnane compound; slow release drug; vitreous body

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.

这项研究的长期长期目标是减少或消除与年龄相关的黄斑变性（ARMD）中脉络膜新生血管膜形成（CNVM）引起的失明。 CRNV的眼睛中有多达87％的眼睛出现“不确定”的病变。 尚未建立针对这种形式的这种形式的脉络膜新生血管化的治疗方法。 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。 由于已显示皮质类固醇可下调炎症和修复中涉及的许多细胞因子，因此本研究旨在评估持续释放玻璃体内糖皮质类固醇植入物的疗效。 该植入物已在动物中进行了广泛的研究，目前正在组织中葡萄膜炎和复发性亚膜膜研究中。临床方案将在国家眼科研究所的临床试验分支机构中进行。 该方案的第1阶段将在40名患者中确定该治疗的可行性和安全性。该快速提案的第二阶段旨在确定功效。该提案要求资金提供支持这些临床试验所需的实验室工作。 CDS的研究人员发明并负责开发Vitrasert Ganciclovir设备：FDA唯一批准的眼内药物输送系统。拟议的商业应用程序成功完成了这项工作，随后可以批准对ARMD进行的第一种药理学疗法。 因此，潜在的商业应用是巨大的。 CD完全致力于该项目，并且出售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3阶段成功。 我们正在与一家主要的眼科制药公司积极谈判，以确保成功商业化。