Topical Insulin for Glaucoma and Optic Neuropathies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-Related Adverse Events
研究概览
简要总结
The purpose of this Phase 1 trial is to determine the safety over 1-2 months of topic sterile human recombinant insulin on subjects with optic neuropathies (glaucoma, ischecmic optic neuropathy, and optic disc drusen).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable to provide informed consent
- •Diagnosis of optic neuropathy either glaucoma or NAION or optic disc drusen.
- •Only one eye per patient will be selected as the study eye - if both eyes meet the inclusion criteria, the eye with the worse acuity and /or visual field will be selected. The contralateral eye will be left untouched.
排除标准
- •Pregnant or breastfeeding woman
- •Presence of any ocular pathologies other than glaucoma that contributes to the severe vision loss (retinopathy / maculopathy, severe uveitis, keratopathy, etc.)
- •Diagnosis of glucose intolerance, type 1 or 2 diabetes mellitus
- •Inability to perform reliable visual field
- •Unable to provide informed consent
- •Unable to complete the tests and follow-ups required by the study
研究组 & 干预措施
Low dose topical insulin
Group 1; N=6: 100 U/ml; 4 units of insulin per application, 1 drop done in clinic daily for 5 days
干预措施: Insulin, 4 units (Drug)
High dose topical insulin
Group 2; N=6: 500 U/ml; 20 units of insulin per application, 1 drop done in clinic daily for 5 days
干预措施: Insulin, 20 units (Drug)
Longer-term topical insulin
Group 3 randomized; N=20: 10 subjects will receive the highest tolerated dose (e.g. from group 1 or group 2), 1 drop per day at home for 1 month, full testing pre- and post-treatment, and 10 subjects will receive 1/5 of the highest tolerated dose (either the lower dose, or if needed will dilute) 1 drop per day at home for 1 month, full testing pre- and post-treatment.
干预措施: Insulin, 4 units (Drug)
Longer-term topical insulin
Group 3 randomized; N=20: 10 subjects will receive the highest tolerated dose (e.g. from group 1 or group 2), 1 drop per day at home for 1 month, full testing pre- and post-treatment, and 10 subjects will receive 1/5 of the highest tolerated dose (either the lower dose, or if needed will dilute) 1 drop per day at home for 1 month, full testing pre- and post-treatment.
干预措施: Insulin, 20 units (Drug)
Low-Dose Insulin twice Daily
Group 4. N=5. 1 drop of 100U/mL insulin administered twice daily for 5 days.
干预措施: insulin, 4 units twice daily (Drug)
High-Dose Insulin twice Daily
Group 5. N=5. 1 drop of 500U/mL insulin administered twice daily for 5 days.
干预措施: insulin, 20 units twice daily (Drug)
Low-Dose Insulin three times daily
Group 6. N=5. 1 drop of 100U/mL insulin administered three times daily for 5 days.
干预措施: insulin, 4 units three times daily (Drug)
High-Dose Insulin three times daily
Group 7. N=5. 1 drop of 500U/mL insulin administered three times daily for 5 days.
干预措施: insulin, 20 units three times daily (Drug)
结局指标
主要结局
Number of Participants with Treatment-Related Adverse Events
时间窗: During treatment period, difference from baseline to post-treatment up to 2 months
determine the safety of topical sterile human insulin in patients with optic neuropathies. AEs and SAEs will be monitored and recorded through the duration of the study.
次要结局
- Change in retinal thickness measured in microns by spectral domain optical coherence tomography (sdOCT)(During treatment period, difference from baseline to post-treatment up to 2 months)
- The change in visual field as measured by mean deviation(During treatment period, difference from baseline to post-treatment up to 2 months)
研究者
Jeffrey L Goldberg
Professor of Ophthalmology
Stanford University