What is the mechanism of action of this treatment?

Common treatments for glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent damage to the optic nerve. These include medications like prostaglandin analogs, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors, which either decrease aqueous humor production or increase its outflow. Neuroprotective or regenerative treatments, such as the trial involving Topic Sterile Human Recombinant Insulin, focus on protecting or repairing the optic nerve directly. This is crucial for glaucoma patients as it addresses the underlying nerve damage, potentially preserving vision and improving outcomes beyond just lowering IOP.

What side effects are associated with this type of intervention?

Common treatments for glaucoma include medications such as prostaglandin analogs, beta-blockers, alpha agonists, carbonic anhydrase inhibitors, and Rho kinase inhibitors. Prostaglandin analogs can cause eye redness, eyelash growth, and changes in iris color. Beta-blockers may lead to systemic effects like bradycardia, hypotension, and respiratory issues. Alpha agonists can cause dry mouth, fatigue, and allergic reactions. Carbonic anhydrase inhibitors might result in a metallic taste, frequent urination, and tingling in fingers and toes. Rho kinase inhibitors can cause eye redness and discomfort. Surgical and laser treatments carry risks of infection, inflammation, and vision changes. The investigational use of topical sterile human recombinant insulin aims to provide neuroprotective or regenerative effects on optic nerves, but its specific side effects are still under study.

What prior FDA approvals exist?

FDA-approved treatments for glaucoma primarily focus on reducing intraocular pressure to prevent optic nerve damage. These include prostaglandin analogs (e.g., latanoprost), beta-blockers (e.g., timolol), alpha agonists (e.g., brimonidine), and carbonic anhydrase inhibitors (e.g., dorzolamide). While these treatments are effective in lowering intraocular pressure, there is limited FDA-approved neuroprotective or regenerative therapy specifically targeting optic nerve health. Research is ongoing in this area, including trials like the one studying topical sterile human recombinant insulin for its potential neuroprotective effects.

What other types of research exist?

Promising novel alternatives for glaucoma treatment in 2024 include: 1) Gene therapy, such as the use of AAV2 vectors to deliver neuroprotective genes to retinal ganglion cells. 2) Stem cell therapy, particularly the transplantation of retinal progenitor cells or mesenchymal stem cells to promote regeneration and repair of optic nerve damage. 3) Neuroprotective agents like brimonidine, which has shown potential in reducing retinal ganglion cell death. 4) Novel small molecules targeting mitochondrial dysfunction and oxidative stress, which are key factors in optic nerve degeneration.

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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

Must not have

Presence of any ocular pathologies other than glaucoma that contributes to severe vision loss (retinopathy, maculopathy, severe uveitis, keratopathy, etc.)

Unable 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

No Placebo-Only Group

Summary

This trial is testing the safety of applying a special form of insulin directly to the eye in patients with optic nerve damage from conditions like glaucoma. The insulin may help heal and protect the damaged nerve cells. Insulin eyedrops have been shown to be feasible for lowering blood glucose in humans and have been tested for safety and efficacy in animal models.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a type of optic nerve damage.

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I am able to understand and agree to the study's procedures and risks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe vision loss due to an eye condition other than glaucoma.

Select...

I am unable to understand and agree to the study's details on my own.

Select...

I have been diagnosed with diabetes or glucose intolerance.

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I cannot perform a reliable visual field test.

Select...

I cannot commit to the study's required tests and follow-ups.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and during treatment period, difference from baseline to post-treatment up to 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Treatment-Related Adverse Events

Secondary study objectives

Change in retinal thickness measured in microns by spectral domain optical coherence tomography (sdOCT)

The change in visual field as measured by mean deviation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Low-Dose Insulin twice DailyExperimental Treatment1 Intervention

Group 4. N=5. 1 drop of 100U/mL insulin administered twice daily for 5 days.

Group II: Low-Dose Insulin three times dailyExperimental Treatment1 Intervention

Group 6. N=5. 1 drop of 100U/mL insulin administered three times daily for 5 days.

Group III: 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 IV: 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 V: High-Dose Insulin twice DailyExperimental Treatment1 Intervention

Group 5. N=5. 1 drop of 500U/mL insulin administered twice daily for 5 days.

Group VI: High-Dose Insulin three times dailyExperimental Treatment1 Intervention

Group 7. N=5. 1 drop of 500U/mL insulin administered three times daily for 5 days.

Group VII: 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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent damage to the optic nerve. These include medications like prostaglandin analogs, beta-blockers, alpha agonists, and carbonic anhydrase inhibitors, which either decrease aqueous humor production or increase its outflow. Neuroprotective or regenerative treatments, such as the trial involving Topic Sterile Human Recombinant Insulin, focus on protecting or repairing the optic nerve directly. This is crucial for glaucoma patients as it addresses the underlying nerve damage, potentially preserving vision and improving outcomes beyond just lowering IOP.