A Phase 1/2 Dose Escalation Followed by a Masked, Randomized, Placebo-Controlled Study to Evaluate Topical Insulin for Neuroprotection in Open Angle Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
研究概览
简要总结
This study evaluates the safety and preliminary efficacy of topical sterile human insulin eye drops (EYED-002) in patients with open-angle glaucoma. The study uses a phase 1/2 dose-escalation design followed by a masked, randomized, placebo-controlled phase. Insulin is formulated as preservative-free eye drops and delivered once daily. The primary objective is to determine the safety profile of topical insulin; secondary objectives assess effects on retinal structure, visual field, visual acuity, contrast sensitivity, and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Masking applies to Group 3 only. Participants randomized in Group 3 are masked to treatment assignment (active vs. vehicle placebo). Groups 1, 2, and 4 are open-label.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Limited Inclusion Criteria - All Groups:
- •Provide written informed consent approved by the appropriate ethics committee
- •Age 18 years or older
- •Understand study procedures and have the ability and willingness to abide by all procedures during the study
- •Capable of providing informed consent
- •Diagnosis of glaucoma
- •Only one eye per patient will be selected as the study eye; if both eyes meet inclusion criteria, the eye with worse visual acuity and/or visual field will be selected
排除标准
- •All Groups:
- •Pregnant or breastfeeding
- •Presence of any ocular pathology other than glaucoma that contributes to severe vision loss (retinopathy, maculopathy, severe uveitis, keratopathy, etc.)
- •Diagnosis of glucose intolerance, type 1 or type 2 diabetes mellitus
- •Inability to perform reliable visual field testing
- •Unable to provide informed consent
- •Unable to complete the tests and follow-ups required by the study
研究者
Jeffrey L Goldberg
Professor and Chair of Ophthalmology
Stanford University