Topical Insulin for Glaucoma

NCT05206877 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 63337
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 visual field as measured by mean deviation

  During treatment period, difference from baseline to post-treatment up to 2 months

Study Arms (7)

Low dose topical insulin

EXPERIMENTAL

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

High dose topical insulin

EXPERIMENTAL

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

Longer-term topical insulin

EXPERIMENTAL

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; Drug: Insulin, 20 units

Low-Dose Insulin twice Daily

EXPERIMENTAL

Group 4. N=5. 1 drop of 100U/mL insulin administered twice daily for 5 days.

Drug: insulin, 4 units twice daily

High-Dose Insulin twice Daily

EXPERIMENTAL

Group 5. N=5. 1 drop of 500U/mL insulin administered twice daily for 5 days.

Drug: insulin, 20 units twice daily

Low-Dose Insulin three times daily

EXPERIMENTAL

Group 6. N=5. 1 drop of 100U/mL insulin administered three times daily for 5 days.

Drug: insulin, 4 units three times daily

High-Dose Insulin three times daily

EXPERIMENTAL

Group 7. N=5. 1 drop of 500U/mL insulin administered three times daily for 5 days.

Drug: insulin, 20 units three times daily

Interventions

Insulin, 4 units DRUG

Topical insulin 100 U/ml, 1 drop per day

Longer-term topical insulin; Low dose topical insulin

Insulin, 20 units DRUG

Topical insulin 500 U/ml, 1 drop per day

High dose topical insulin; Longer-term topical insulin

insulin, 4 units twice daily DRUG

1 drop of low dose insulin twice daily.

Low-Dose Insulin twice Daily

insulin, 20 units twice daily DRUG

1 drop of high dose insulin twice daily

High-Dose Insulin twice Daily

insulin, 4 units three times daily DRUG

1 drop of low dose insulin three times daily.

Low-Dose Insulin three times daily

insulin, 20 units three times daily DRUG

1 drop of high dose insulin three times daily.

High-Dose Insulin three times daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable to provide informed consent
• Diagnosis of optic neuropathy either glaucoma or NAION or optic disc drusen.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Insulin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jeffrey L Goldberg, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariana Nunez, MD

CONTACT

650-497-7846; mnunez1@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: January 25, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)