Recruiting
Phase 1

Topical Insulin

Sponsor:

Stanford University

Code:

NCT05206877

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Insulin, 4 units

Insulin, 20 units

insulin, 4 units twice daily

insulin, 20 units twice daily

insulin, 4 units three times daily

Study Details

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

Study ID

NCT05206877

Start date

Apr 1, 2022

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

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.

experimental: Low-Dose Insulin twice Daily

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

experimental: High-Dose Insulin twice Daily

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

experimental: Low-Dose Insulin three times daily

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

experimental: High-Dose Insulin three times daily

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

Interventions

Insulin, 4 units

Topical insulin 100 U/ml, 1 drop per day

Insulin, 20 units

Topical insulin 500 U/ml, 1 drop per day

insulin, 4 units twice daily

1 drop of low dose insulin twice daily.

insulin, 20 units twice daily

1 drop of high dose insulin twice daily

insulin, 4 units three times daily

1 drop of low dose insulin three times daily.

insulin, 20 units three times daily

1 drop of high dose insulin three times daily.

Primary outcome measure

  • Number of Participants with Treatment-Related Adverse Events [ Time Frame: During treatment period, difference from baseline to post-treatment up to 2 months ]

Central Contacts and Locations

Central contacts

Mariana Nunez, MD

650-497-7846mnunez1@stanford.edu

Locations

Byers Eye Institute at Stanford University

Recruiting

Palo Alto, California, United States, 94303

Contacts

Zac Wennberg-Smith

zacwenn@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-11-25.