Topical Insulin for Glaucoma

Last updated: October 28, 2024
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

1

Condition

Glaucoma

Treatment

Insulin, 4 units

insulin, 20 units three times daily

insulin, 4 units twice daily

Clinical Study ID

NCT05206877
63337
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 theinclusion criteria, the eye with the worse acuity and /or visual field will beselected. The contralateral eye will be left untouched.

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding woman

  • Presence of any ocular pathologies other than glaucoma that contributes to thesevere 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

Study Design

Total Participants: 52
Treatment Group(s): 6
Primary Treatment: Insulin, 4 units
Phase: 1
Study Start date:
April 01, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Byers Eye Institute at Stanford University

    Palo Alto, California 94303
    United States

    Active - Recruiting

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