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Hormone Therapy
Topical Insulin for Glaucoma (TING1 Trial)
Phase 1
Recruiting
Led By Jeffrey L Goldberg, MD, PhD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of optic neuropathy (glaucoma, NAION, or optic disc drusen)
Capable to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during treatment period, difference from baseline to post-treatment up to 2 months
Awards & highlights
TING1 Trial Summary
This trial is testing a new type of insulin to see if it is safe for people with optic neuropathies.
Who is the study for?
This trial is for individuals with optic neuropathies like glaucoma, who can give informed consent and have one eye worse than the other; the worse eye will be treated. Excluded are those with diabetes, unreliable visual field tests, inability to consent or follow study procedures, pregnant or breastfeeding women, and severe vision loss from other ocular diseases.Check my eligibility
What is being tested?
The trial is testing the safety of topical sterile human recombinant insulin in two different doses (4 units and 20 units) on patients with glaucoma over a period of 1-2 months to see how well they tolerate it and any effects it has on their condition.See study design
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on safety, specific side effects are not listed but may include potential irritation at the application site or systemic effects due to insulin absorption.
TING1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of optic nerve damage.
Select...
I am able to understand and agree to the study's procedures and risks.
TING1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during treatment period, difference from baseline to post-treatment up to 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during treatment period, difference from baseline to post-treatment up to 2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Treatment-Related Adverse Events
Secondary outcome measures
Change in retinal thickness measured in microns by spectral domain optical coherence tomography (sdOCT)
The change in visual field as measured by mean deviation
TING1 Trial Design
3Treatment groups
Experimental Treatment
Group I: Low dose topical insulinExperimental Treatment1 Intervention
Group 1; N=6: 100 U/ml; 4 units of insulin per application, 1 drop done in clinic daily for 5 days
Group II: Longer-term topical insulinExperimental Treatment2 Interventions
Group 3 randomized; N=20: 10 subjects will receive the highest tolerated dose (e.g. from group 1 or group 2), 1 drop per day at home for 1 month, full testing pre- and post-treatment, and 10 subjects will receive 1/5 of the highest tolerated dose (either the lower dose, or if needed will dilute) 1 drop per day at home for 1 month, full testing pre- and post-treatment.
Group III: High dose topical insulinExperimental Treatment1 Intervention
Group 2; N=6: 500 U/ml; 20 units of insulin per application, 1 drop done in clinic daily for 5 days
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,394 Previous Clinical Trials
17,341,578 Total Patients Enrolled
12 Trials studying Glaucoma
571 Patients Enrolled for Glaucoma
Jeffrey L Goldberg, MD, PhDPrincipal InvestigatorStanford University
4 Previous Clinical Trials
198 Total Patients Enrolled
4 Trials studying Glaucoma
198 Patients Enrolled for Glaucoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe vision loss due to an eye condition other than glaucoma.Only my worse eye will be treated in the study.I have been diagnosed with a type of optic nerve damage.I have been diagnosed with a type of optic nerve damage.Only my worse eye will be treated in the study.I am unable to understand and agree to the study's details on my own.I have been diagnosed with diabetes or glucose intolerance.I cannot perform a reliable visual field test.I am able to understand and agree to the study's procedures and risks.I cannot commit to the study's required tests and follow-ups.
Research Study Groups:
This trial has the following groups:- Group 1: Longer-term topical insulin
- Group 2: Low dose topical insulin
- Group 3: High dose topical insulin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Glaucoma Patient Testimony for trial: Trial Name: NCT05206877 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available to participants in this research trial?
"Affirmative. Clinicaltrials.gov's records confirm that this clinical trial, which was unveiled on April 1st 2022 is actively recruiting subjects. Specifically, 32 participants need to be sourced from a single medical centre."
Answered by AI
What is the aggregate quantity of participants in this research endeavor?
"Affirmative. According to clinicaltrials.gov, this research project is still enrolling patients, with the initial posting of April 1st 2022 and last update on May 9th 2022. The trial seeks 32 participants from one single medical centre."
Answered by AI
Has the FDA certified twenty-unit insulin for public use?
"Our internal analysis concluded that Insulin, 20 units' safety is only moderately established due to the limited evidence available. Consequently we assigned it a score of 1."
Answered by AI
Who else is applying?
What state do they live in?
New Hampshire
California
How old are they?
65+
18 - 65
What site did they apply to?
Byers Eye Institute at Stanford University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
Why did patients apply to this trial?
I have visual loss. Insulin eye drop treatment. I have had multiple treatments including Xen stent, goniotomy, laser, multiple glaucoma eye drops and still over decades have lost 65% of the visual fields including the upper half of my central vision. Cannot drive confidently any longer.
PatientReceived no prior treatments
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