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RECRUITINGPhase 1INTERVENTIONAL

Topical Insulin for Glaucoma

Topical Insulin for Glaucoma and Optic Neuropathies

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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