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NCT05206877PHASE1Recruiting

Topical Insulin for Glaucoma

Stanford University

Start Date

4/1/2022

Completion Date

12/31/2026

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).

Eligibility Criteria

Age Range: 18 years to No maximum

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

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

Interested in This Trial?

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Conditions

Glaucoma

Locations

Byers Eye Institute at Stanford University

Palo Alto, California 94303

United States