Topical Insulin for Glaucoma

Study Overview
=================
Brief 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).

Official Title
-----------------
Topical Insulin for Glaucoma and Optic Neuropathies

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Drug: Insulin, 4 units
* Drug: Insulin, 20 units


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose topical insulin<br>Group 1; N=6: 100 U/ml; 4 units of insulin per application, 1 drop done in clinic daily for 5 days | Drug: Insulin, 4 units<br>* Topical insulin 100 U/ml, 1 drop per day<br>|
| Experimental: High dose topical insulin<br>Group 2; N=6: 500 U/ml; 20 units of insulin per application, 1 drop done in clinic daily for 5 days | Drug: Insulin, 20 units<br>* Topical insulin 500 U/ml, 1 drop per day<br>|
| Experimental: Longer-term topical insulin<br>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. | Drug: Insulin, 4 units<br>* Topical insulin 100 U/ml, 1 drop per day<br>Drug: Insulin, 20 units<br>* Topical insulin 500 U/ml, 1 drop per day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |