Recruiting
Topical Insulin for Glaucoma
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).
ClinicalTrials.gov IDNCT05206877
PhasePHASE1
Enrollment52
SponsorStanford University
Age18 Years
SexALL
Conditions studied
Glaucoma
About this study
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).
Interventions
- Drug: Insulin, 4 units — Topical insulin 100 U/ml, 1 drop per day
- Drug: Insulin, 20 units — Topical insulin 500 U/ml, 1 drop per day
- Drug: insulin, 4 units twice daily — 1 drop of low dose insulin twice daily.
- Drug: insulin, 20 units twice daily — 1 drop of high dose insulin twice daily
- Drug: insulin, 4 units three times daily — 1 drop of low dose insulin three times daily.
- Drug: insulin, 20 units three times daily — 1 drop of high dose insulin three times daily.
Primary outcomes
- Number of Participants with Treatment-Related Adverse Events (During treatment period, difference from baseline to post-treatment up to 2 months)
Eligibility information
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 locations
- Byers Eye Institute at Stanford University, Palo Alto, California 94303 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.