Topical Insulin for Open-Angle Glaucoma

ST
Overseen ByStudy Team
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Stanford University

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests eye drops made from insulin to determine their safety and effectiveness for people with open-angle glaucoma, a common eye condition that can lead to vision loss. The study examines different doses to identify the most effective one while monitoring for side effects. Individuals with open-angle glaucoma who have one eye with worse vision might be suitable candidates for this trial. As a Phase 1/Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial group, offering participants a chance to be among the first to benefit from this innovative approach.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that insulin eye drops, such as EYED-002, are generally safe for treating open-angle glaucoma. Studies have found that both low and high doses are well-tolerated. The most common side effect is a mild, temporary stinging sensation after use. Importantly, no serious side effects have been reported. Additionally, studies with doses up to 500 units per milliliter have shown no major problems with short-term use. This safety information suggests that insulin eye drops for glaucoma could be a promising and safe treatment option.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for open-angle glaucoma, which often involve eye drops to lower eye pressure, the investigational treatment EYED-002 uses topical insulin. Researchers are excited about this approach because insulin has unique properties that may protect and regenerate nerve cells in the eye, potentially addressing the disease's root cause rather than just the symptoms. Additionally, this treatment is delivered through eye drops, making it a familiar and non-invasive option for patients, with the potential to show results in just a few days.

What evidence suggests that this trial's treatments could be effective for open-angle glaucoma?

This trial will evaluate the effects of topical insulin eye drops, EYED-002, for treating open-angle glaucoma. Participants will join different groups to receive either low-dose, high-dose, or the highest tolerated dose of EYED-002 for an extended period. Research has shown that insulin eye drops might help treat open-angle glaucoma by focusing on nerve health rather than just reducing eye pressure. Studies have found that these drops are generally safe and well-tolerated, even at higher doses, with no serious eye-related side effects. Early results suggest that insulin may help heal eye tissues, offering promise for people with glaucoma. While researchers are still studying the exact effects on vision, the potential to improve eye structure and function makes this an exciting area of research.12356

Who Is on the Research Team?

JL

Jeffrey L Goldberg, MD PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with open-angle glaucoma, including normal tension and pseudoexfoliation types. Participants should not have other major eye diseases or conditions that could interfere with the study.

Inclusion Criteria

I have been diagnosed with glaucoma.
I am 18 years old or older.
Provide written informed consent approved by the appropriate ethics committee
See 3 more

Exclusion Criteria

Unable to complete the tests and follow-ups required by the study
I have been diagnosed with diabetes or glucose intolerance.
Inability to perform reliable visual field testing
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive low or high-dose topical insulin (EYED-002) once daily in-clinic for 5 consecutive days

1 week
5 visits (in-person)

Randomized Treatment

Participants receive either active EYED-002 or placebo once daily at home for 12 months

12 months
Monthly visits (in-person or virtual)

Open-Label Extension

Eligible participants may continue receiving active EYED-002 for an additional 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • EYED-002 High Dose (1442 U/mL topical insulin)
  • EYED-002 (highest tolerated dose, 12-month)
  • EYED-002 Low Dose (721 U/mL topical insulin)

Trial Overview

The study tests different doses of insulin eye drops (EYED-002) compared to placebo in people with glaucoma. The goal is to see if these daily drops are safe and whether they help protect vision over up to 12 months.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 4: Open-Label AccessExperimental Treatment1 Intervention
Group II: Group 3: Active EYED-002 (Randomized)Experimental Treatment1 Intervention
Group III: Group 2: High-Dose EYED-002Experimental Treatment1 Intervention
Group IV: Group 1: Low-Dose EYED-002Experimental Treatment1 Intervention
Group V: Group 3: Vehicle Placebo (Randomized)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

A Phase I Randomized Trial of Topical Insulin for Glaucoma

No serious ophthalmic AEs due to the topical insulin drops were recorded. Most of the AEs were mild and included stinging, watery eyes, and dry-eye sensation, ...

NCT07619482 | Topical Insulin for Glaucoma (TING2)

This study evaluates the safety and preliminary efficacy of topical sterile human insulin eye drops (EYED-002) in patients with open-angle ...

Safety of Topical Insulin Drops for Open-angle Glaucoma

Hypothesis of the study: Topical ocular insulin (up to 500 U/ml) at once per day dosing is safe in patients with open angle glaucoma.

Insulin Eye Drops for Ocular Diseases

“This study points to early evidence for using insulin as an eye drop in the treatment of glaucoma — not for eye pressure control, but targeting ...

Safety of insulin eye drops in the tratment of open angle ...

In conclusion, we found that 100 units/mL and 500 units/mL of topical insulin daily is safe for short-term use in patients with glaucoma.

Topical Insulin for Glaucoma (TING2) - ClinicalTrials.Veeva

This study evaluates the safety and preliminary efficacy of topical sterile human insulin eye drops (EYED-002) in patients with open-angle ...