Recruiting NCT05206877
Topical Insulin for Glaucoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Insulin, 4 units, Insulin, 20 units, insulin, 4 units twice daily, insulin, 20 units twice daily.
- Who it may be relevant to
- Registry conditions: Glaucoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Topical Insulin for Glaucoma and Optic Neuropathies
Overview
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
- 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.
Primary outcome measures
- Number of Participants with Treatment-Related Adverse Events [Time frame: During treatment period, difference from baseline to post-treatment up to 2 months]
Secondary outcome measures (2)
- Change in retinal thickness measured in microns 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 [Time frame: During treatment period, difference from baseline to post-treatment up to 2 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Byers Eye Institute at Stanford University — Palo Alto
Identifiers
NCT: NCT05206877 · 63337