Topical Insulin for Glaucoma (TING1)

Topical Insulin for Glaucoma and Optic Neuropathies

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).

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Insulin, 4 units; Drug: Insulin, 20 units

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mariana Nunez, MD; Phone Number: 650-497-7846; Email: mnunez1@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Recruiting
      • Byers Eye Institute at Stanford University
      • Contact: Esther Elenes; Email: eelenes@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Insulin, 4 units; Topical insulin 100 U/ml, 1 drop per day
Experimental: 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	Drug: Insulin, 20 units; Topical insulin 500 U/ml, 1 drop per day
Experimental: 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.	Drug: Insulin, 4 units; Topical insulin 100 U/ml, 1 drop per day; Drug: Insulin, 20 units; Topical insulin 500 U/ml, 1 drop per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-Related Adverse Events	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.	During treatment period, difference from baseline to post-treatment up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in retinal thickness measured in microns by spectral domain optical coherence tomography (sdOCT)	The change in retinal thickness as measured 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	The change in visual field as measured by mean deviation on Zeiss Humphrey Visual Field testing	During treatment period, difference from baseline to post-treatment up to 2 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Jeffrey L Goldberg, MD, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 63337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No