Topical Insulin for Glaucoma (TING1)

Stanford University

Status and phase: Enrolling; Phase 1

Conditions: Glaucoma

Treatments: Drug: insulin, 20 units twice daily; Drug: Insulin, 4 units; Drug: Insulin, 20 units; Drug: insulin, 20 units three times daily; Drug: insulin, 4 units three times daily; Drug: insulin, 4 units twice daily

Study type: Interventional

Funder types: Other

Identifiers

NCT05206877

63337

Details and patient eligibility

About

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).

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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52 participants in 7 patient groups

Low dose topical insulin

Experimental group

Description:

Group 1; N=6: 100 U/ml; 4 units of insulin per application, 1 drop done in clinic daily for 5 days

Treatment:

Drug: Insulin, 4 units

High dose topical insulin

Experimental group

Description:

Group 2; N=6: 500 U/ml; 20 units of insulin per application, 1 drop done in clinic daily for 5 days

Treatment:

Drug: Insulin, 20 units

Longer-term topical insulin

Experimental group

Description:

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.

Treatment:

Drug: Insulin, 20 units

Drug: Insulin, 4 units

Low-Dose Insulin twice Daily

Experimental group

Description:

Group 4. N=5. 1 drop of 100U/mL insulin administered twice daily for 5 days.

Treatment:

Drug: insulin, 4 units twice daily

High-Dose Insulin twice Daily

Experimental group

Description:

Group 5. N=5. 1 drop of 500U/mL insulin administered twice daily for 5 days.

Treatment:

Drug: insulin, 20 units twice daily

Low-Dose Insulin three times daily

Experimental group

Description:

Group 6. N=5. 1 drop of 100U/mL insulin administered three times daily for 5 days.

Treatment:

Drug: insulin, 4 units three times daily

High-Dose Insulin three times daily

Experimental group

Description:

Group 7. N=5. 1 drop of 500U/mL insulin administered three times daily for 5 days.

Treatment:

Drug: insulin, 20 units three times daily