Topical insulin treatment for glaucoma
Topical Insulin for Glaucoma and Optic Neuropathies
This study is testing if applying insulin directly to the eye can be a safe treatment for people with glaucoma and other optic nerve problems.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05206877 on ClinicalTrials.gov |
What this trial studies
This Phase 1 trial aims to evaluate the safety of topical sterile human recombinant insulin in patients with optic neuropathies, including glaucoma, over a period of 1-2 months. Participants will receive varying doses of insulin applied to the affected eye, with the goal of assessing any adverse effects. The study will focus on one eye per patient, specifically selecting the eye with the worse visual acuity or visual field. The trial will help determine if insulin can be a viable treatment option for patients suffering from these conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with glaucoma or other specified optic neuropathies who can provide informed consent.
Not a fit: Patients with other ocular pathologies contributing to severe vision loss or those with diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with glaucoma and other optic neuropathies.
How similar studies have performed: While this approach is novel, similar studies exploring insulin's effects on ocular conditions have shown promise, but this specific application is less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palo Alto, California
- Byers Eye Institute at Stanford University — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Jeffrey L Goldberg, MD, PhD — Stanford University
- Study coordinator: Mariana Nunez, MD
- Email: mnunez1@stanford.edu
- Phone: 650-497-7846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.