Topical Insulin for Glaucoma

Glaucoma Clinical Trial

— TING1  

Official title:

Topical Insulin for Glaucoma and Optic Neuropathies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206877
• Other study ID #: 63337
• Status: Recruiting
• Phase: Phase 1
• Start date: April 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Mariana Nunez, MD
• Phone: 650-497-7846
• Email: mnunez1[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Insulin, 4 units
Topical insulin 100 U/ml, 1 drop per day
• Insulin, 20 units
Topical insulin 500 U/ml, 1 drop per day

Locations

Country	Name	City	State
United States	Byers Eye Institute at Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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