Glaucoma
Conditions
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).
Interventions
DRUGInsulin, 4 units
Topical insulin 100 U/ml, 1 drop per day
DRUGInsulin, 20 units
Topical insulin 500 U/ml, 1 drop per day
DRUGinsulin, 4 units twice daily
1 drop of low dose insulin twice daily.
DRUGinsulin, 20 units twice daily
1 drop of high dose insulin twice daily
DRUGinsulin, 4 units three times daily
1 drop of low dose insulin three times daily.
DRUGinsulin, 20 units three times daily
1 drop of high dose insulin three times daily.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events | During treatment period, difference from baseline to post-treatment up to 2 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in retinal thickness measured in microns by spectral domain optical coherence tomography (sdOCT) | During treatment period, difference from baseline to post-treatment up to 2 months | The change in retinal thickness as measured by spectral domain optical coherence tomography (sdOCT) |
| The change in visual field as measured by mean deviation | During treatment period, difference from baseline to post-treatment up to 2 months | The change in visual field as measured by mean deviation on Zeiss Humphrey Visual Field testing |
Countries
United States
Contacts
Primary ContactMariana Nunez, MD
Outcome results
None listed