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Topical Insulin for Glaucoma (TING1)

Primary Purpose

Glaucoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Insulin, 4 units
Insulin, 20 units
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Byers Eye Institute at Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Low dose topical insulin

High dose topical insulin

Longer-term topical insulin

Arm Description

Group 1; N=6: 100 U/ml; 4 units of insulin per application, 1 drop done in clinic daily for 5 days

Group 2; N=6: 500 U/ml; 20 units of insulin per application, 1 drop done in clinic daily for 5 days

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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

Full Information

First Posted
January 6, 2022
Last Updated
May 9, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05206877
Brief Title
Topical Insulin for Glaucoma
Acronym
TING1
Official Title
Topical Insulin for Glaucoma and Optic Neuropathies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose topical insulin
Arm Type
Experimental
Arm Description
Group 1; N=6: 100 U/ml; 4 units of insulin per application, 1 drop done in clinic daily for 5 days
Arm Title
High dose topical insulin
Arm Type
Experimental
Arm Description
Group 2; N=6: 500 U/ml; 20 units of insulin per application, 1 drop done in clinic daily for 5 days
Arm Title
Longer-term topical insulin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin, 4 units
Intervention Description
Topical insulin 100 U/ml, 1 drop per day
Intervention Type
Drug
Intervention Name(s)
Insulin, 20 units
Intervention Description
Topical insulin 500 U/ml, 1 drop per day
Primary Outcome Measure Information:
Title
Number of Participants with Treatment-Related Adverse Events
Description
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.
Time Frame
During treatment period, difference from baseline to post-treatment up to 2 months
Secondary Outcome Measure Information:
Title
Change in retinal thickness measured in microns by spectral domain optical coherence tomography (sdOCT)
Description
The change in retinal thickness as measured by spectral domain optical coherence tomography (sdOCT)
Time Frame
During treatment period, difference from baseline to post-treatment up to 2 months
Title
The change in visual field as measured by mean deviation
Description
The change in visual field as measured by mean deviation on Zeiss Humphrey Visual Field testing
Time Frame
During treatment period, difference from baseline to post-treatment up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana Nunez, MD
Phone
650-497-7846
Email
mnunez1@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey L Goldberg, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Byers Eye Institute at Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Elenes
Email
eelenes@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No current plan to share individual participant data

Learn more about this trial

Topical Insulin for Glaucoma

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