Topical Insulin for Glaucoma and Optic Neuropathies
Who is this study for? Patients with glaucoma and optic neuropathies
What treatments are being studied? Insulin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Byers Eye Institute at Stanford University
RECRUITING
Palo Alto
Contact Information
Primary
Mariana Nunez, MD
mnunez1@stanford.edu
650-497-7846
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 52
Treatments
Experimental: 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
Experimental: 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
Experimental: 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.
Experimental: Low-Dose Insulin twice Daily
Group 4. N=5. 1 drop of 100U/mL insulin administered twice daily for 5 days.
Experimental: High-Dose Insulin twice Daily
Group 5. N=5. 1 drop of 500U/mL insulin administered twice daily for 5 days.
Experimental: Low-Dose Insulin three times daily
Group 6. N=5. 1 drop of 100U/mL insulin administered three times daily for 5 days.
Experimental: High-Dose Insulin three times daily
Group 7. N=5. 1 drop of 500U/mL insulin administered three times daily for 5 days.
Related Therapeutic Areas
Sponsors
Leads: Stanford University