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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
Topical insulin 100 U/ml, 1 drop per day
Topical insulin 500 U/ml, 1 drop per day
1 drop of low dose insulin twice daily.
Byers Eye Institute at Stanford University
Palo Alto, California, United States
RECRUITINGNumber 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.
Time frame: During treatment period, difference from baseline to post-treatment up to 2 months
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)
Time frame: 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
Time frame: During treatment period, difference from baseline to post-treatment up to 2 months
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1 drop of high dose insulin twice daily
1 drop of low dose insulin three times daily.
1 drop of high dose insulin three times daily.