RECRUITINGPhase 1INTERVENTIONAL
Topical Insulin for Glaucoma
Topical Insulin for Glaucoma and Optic Neuropathies
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- Capable to provide willing to sign a consent form
- 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.
Who Should NOT Join This Trial:
- 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 willing to sign a consent form
- Unable to complete the tests and follow-ups required by the study
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Insulin, 4 units
Topical insulin 100 U/ml, 1 drop per day
DRUG
Insulin, 20 units
Topical insulin 500 U/ml, 1 drop per day
DRUG
insulin, 4 units twice daily
1 drop of low dose insulin twice daily.
DRUG
insulin, 20 units twice daily
1 drop of high dose insulin twice daily
DRUG
insulin, 4 units three times daily
1 drop of low dose insulin three times daily.
DRUG
insulin, 20 units three times daily
1 drop of high dose insulin three times daily.
Locations (1)
Byers Eye Institute at Stanford University
Palo Alto, California, United States