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Topical Insulin for Glaucoma (TING2)

2026年5月26日 更新者：Jeffrey L Goldberg、Stanford University

A Phase 1/2 Dose Escalation Followed by a Masked, Randomized, Placebo-Controlled Study to Evaluate Topical Insulin for Neuroprotection in Open Angle Glaucoma

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

90

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • California
      • Palo Alto、California、美国、94303
        • Byers Eye Institute at Stanford University
        • 首席研究员：
          • Jeffrey Goldberg, MD PhD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

Limited Exclusion Criteria - 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Group 1: Low-Dose EYED-002
N=5 participants with open-angle glaucoma. Low-dose topical insulin (EYED-002), administered as one drop to the study eye once daily in-clinic for 5 consecutive days. Open-label.
药品：EYED-002 Low Dose (721 U/mL topical insulin)
Sterile, preservative-free suspension of Human Insulin USP. One drop to study eye for duration of study group.
其他名称：
  • Topical Sterile Human Insulin
实验性的：Group 2: High-Dose EYED-002
N=5 participants with open-angle glaucoma. High-dose topical insulin (EYED-002), administered as one drop to the study eye once daily in-clinic for 5 consecutive days.
药品：EYED-002 High Dose (1442 U/mL topical insulin)
Sterile, preservative-free suspension of Human Insulin USP. One drop to study eye once daily in-clinic for duration of study group.
其他名称：
  • Topical Sterile Human Insulin
实验性的：Group 3: Active EYED-002 (Randomized)
N=40 participants randomized to active EYED-002 at the highest tolerated dose from Groups 1 or 2, administered once daily at home for 12 months. Double -masked.
药品：EYED-002 (highest tolerated dose, 12-month)
Highest tolerated dose of EYED-002 (721 U/mL or 1442 U/mL, determined from Groups 1 and 2 safety review). Once daily at home for 12 months in single-use vials, dispensed at quarterly visits.
其他名称：
  • Topical Sterile Human Insulin
安慰剂比较：Group 3: Vehicle Placebo (Randomized)
N=20 participants randomized to vehicle-only placebo, administered once daily at home for 12 months. double-masked. Eligible participants may roll over to open-label active EYED-002 for an additional 12 months after Month 12.
药品：Vehicle Placebo
Vehicle-only formulation without active insulin. Single-use vials identical in appearance to active EYED-002. Once daily at home for 12 months.
其他名称：
  • Placebo eye drop
实验性的：Group 4: Open-Label Access
N=20 participants ineligible for randomization due to glaucoma severity. Receive highest tolerated dose of EYED-002 once daily for 12 months in an open-label access arm.
药品：EYED-002 (highest tolerated dose, 12-month)
Highest tolerated dose of EYED-002 (721 U/mL or 1442 U/mL, determined from Groups 1 and 2 safety review). Once daily at home for 12 months in single-use vials, dispensed at quarterly visits.
其他名称：
  • Topical Sterile Human Insulin

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence and severity of ocular and systemic adverse events (AEs) and serious adverse events (SAEs)
大体时间：From informed consent through end of participation (up to 27 months)
Safety of topical sterile human insulin (EYED-002) in patients with open-angle glaucoma. AEs and SAEs classified using MedDRA nomenclature, assessed for severity (mild, moderate, severe) and causality. Safety monitoring includes glycemia measurements before and 2 hours after in-clinic insulin administration, and serial serum electrolyte (potassium) measurements.
From informed consent through end of participation (up to 27 months)

次要结果测量

结果测量
措施说明
大体时间
Change in retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness by SD-OCT
大体时间：Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)
Change in retinal thickness as measured by spectral domain optical coherence tomography (SD-OCT).
Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)
Change in visual field by Humphrey 24-2 (mean deviation, VFI, pointwise analysis)
大体时间：Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)
Change in visual field as measured by mean deviation, visual field index, and pointwise analysis on Humphrey 24-2 testing.
Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)
Change in best corrected visual acuity (BCVA) by ETDRS
大体时间：Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)
Change in visual acuity as measured by ETDRS chart.
Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)
Change in contrast sensitivity by FrACT contrast test
大体时间：Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)
Change in contrast sensitivity as measured by the computer-based FrACT contrast test.
Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)
Change in quality of life by GQL-15 questionnaire
大体时间：Baseline, 6 months, and 12 months (Group 3)
Change in patient-reported quality of life as measured by the Glaucoma Quality of Life-15 (GQL-15) questionnaire.
Baseline, 6 months, and 12 months (Group 3)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Stanford University

调查人员

  • 首席研究员：Jeffrey L Goldberg, MD PhD、Stanford University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年10月1日

研究完成 (估计的)

2029年10月1日

研究注册日期

首次提交

2026年5月26日

首先提交符合 QC 标准的

2026年5月26日

首次发布 (实际的)

2026年6月2日

研究记录更新

最后更新发布 (实际的)

2026年6月2日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 73339

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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