Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
52 participants
INTERVENTIONAL
2022-04-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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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
Insulin, 4 units
Topical insulin 100 U/ml, 1 drop per day
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
Insulin, 20 units
Topical insulin 500 U/ml, 1 drop per day
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.
Insulin, 4 units
Topical insulin 100 U/ml, 1 drop per day
Insulin, 20 units
Topical insulin 500 U/ml, 1 drop per day
Low-Dose Insulin twice Daily
Group 4. N=5. 1 drop of 100U/mL insulin administered twice daily for 5 days.
insulin, 4 units twice daily
1 drop of low dose insulin twice daily.
High-Dose Insulin twice Daily
Group 5. N=5. 1 drop of 500U/mL insulin administered twice daily for 5 days.
insulin, 20 units twice daily
1 drop of high dose insulin twice daily
Low-Dose Insulin three times daily
Group 6. N=5. 1 drop of 100U/mL insulin administered three times daily for 5 days.
insulin, 4 units three times daily
1 drop of low dose insulin three times daily.
High-Dose Insulin three times daily
Group 7. N=5. 1 drop of 500U/mL insulin administered three times daily for 5 days.
insulin, 20 units three times daily
1 drop of high dose insulin three times daily.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of optic neuropathy either glaucoma or NAION or optic disc drusen.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Jeffrey L Goldberg
Professor of Ophthalmology
Principal Investigators
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Jeffrey L Goldberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Byers Eye Institute at Stanford University
Palo Alto, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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63337
Identifier Type: -
Identifier Source: org_study_id
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