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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose topical insulin | Experimental | Group 1; N=6: 100 U/ml; 4 units of insulin per application, 1 drop done in clinic daily for 5 days |
|
| High dose topical insulin | Experimental | Group 2; N=6: 500 U/ml; 20 units of insulin per application, 1 drop done in clinic daily for 5 days |
|
| Longer-term topical insulin | Experimental | 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. |
|
| Low-Dose Insulin twice Daily | Experimental | Group 4. N=5. 1 drop of 100U/mL insulin administered twice daily for 5 days. |
|
| High-Dose Insulin twice Daily | Experimental | Group 5. N=5. 1 drop of 500U/mL insulin administered twice daily for 5 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin, 4 units | Drug | Topical insulin 100 U/ml, 1 drop per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events | determine the safety of topical sterile human insulin in patients with optic neuropathies. AEs and SAEs will be monitored and recorded through the duration of the study. | During treatment period, difference from baseline to post-treatment up to 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in retinal thickness measured in microns by spectral domain optical coherence tomography (sdOCT) | The change in retinal thickness as measured by spectral domain optical coherence tomography (sdOCT) | During treatment period, difference from baseline to post-treatment up to 2 months |
| The change in visual field as measured by mean deviation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariana Nunez, MD | Contact | 650-497-7846 | mnunez1@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Goldberg, MD, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford University | Recruiting | Palo Alto | California | 94303 | United States |
No current plan to share individual participant data
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Low-Dose Insulin three times daily | Experimental | Group 6. N=5. 1 drop of 100U/mL insulin administered three times daily for 5 days. |
|
| High-Dose Insulin three times daily | Experimental | Group 7. N=5. 1 drop of 500U/mL insulin administered three times daily for 5 days. |
|
| Insulin, 20 units | Drug | Topical insulin 500 U/ml, 1 drop per day |
|
| insulin, 4 units twice daily | Drug | 1 drop of low dose insulin twice daily. |
|
| insulin, 20 units twice daily | Drug | 1 drop of high dose insulin twice daily |
|
| insulin, 4 units three times daily | Drug | 1 drop of low dose insulin three times daily. |
|
| insulin, 20 units three times daily | Drug | 1 drop of high dose insulin three times daily. |
|
The change in visual field as measured by mean deviation on Zeiss Humphrey Visual Field testing |
| During treatment period, difference from baseline to post-treatment up to 2 months |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |