Topical Insulin for Glaucoma

Conditions

• Glaucoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Insulin, 4 units — DRUG
  Topical insulin 100 U/ml, 1 drop per day
• Insulin, 20 units — DRUG
  Topical insulin 500 U/ml, 1 drop per day
• insulin, 4 units twice daily — DRUG
  1 drop of low dose insulin twice daily.
• insulin, 20 units twice daily — DRUG
  1 drop of high dose insulin twice daily
• insulin, 4 units three times daily — DRUG
  1 drop of low dose insulin three times daily.
• insulin, 20 units three times daily — DRUG
  1 drop of high dose insulin three times daily.

Study Details

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).

Key Dates

Start date

Apr 1, 2022

Status verified

Nov 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

52 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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.

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

• Mariana Nunez, MD
  650-497-7846
  [email protected]

Locations (1)

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