Topical Insulin for Glaucoma

Phase 1

Recruiting

• Conditions: Glaucoma
• Interventions: Drug: Insulin, 4 units; Drug: Insulin, 20 units; Drug: insulin, 4 units twice daily; Drug: insulin, 20 units twice daily; Drug: insulin, 4 units three times daily; Drug: insulin, 20 units three times daily

• Registration Number: NCT05206877
• Lead Sponsor: Stanford University

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-11
• Study First Posted: 2022-01-25
• Study Start: 2022-04-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low dose topical insulin	Insulin, 4 units	Group 1; N=6: 100 U/ml; 4 units of insulin per application, 1 drop done in clinic daily for 5 days
High dose topical insulin	Insulin, 20 units	Group 2; N=6: 500 U/ml; 20 units of insulin per application, 1 drop done in clinic daily for 5 days
Longer-term topical insulin	Insulin, 4 units	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.
Longer-term topical insulin	Insulin, 20 units	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.
Low-Dose Insulin twice Daily	insulin, 4 units twice daily	Group 4. N=5. 1 drop of 100U/mL insulin administered twice daily for 5 days.
High-Dose Insulin twice Daily	insulin, 20 units twice daily	Group 5. N=5. 1 drop of 500U/mL insulin administered twice daily for 5 days.
Low-Dose Insulin three times daily	insulin, 4 units three times daily	Group 6. N=5. 1 drop of 100U/mL insulin administered three times daily for 5 days.
High-Dose Insulin three times daily	insulin, 20 units three times daily	Group 7. N=5. 1 drop of 500U/mL insulin administered three times daily for 5 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-Related Adverse Events	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Byers Eye Institute at Stanford University; 🇺🇸 Palo Alto, California, United States