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
Conditions
Glaucoma
Locations
Byers Eye Institute at Stanford University
Palo Alto, California 94303
United States