Topical Insulin for Glaucoma (TING2)

NCT07619482 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 73339
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and preliminary efficacy of topical sterile human insulin eye drops (EYED-002) in patients with open-angle glaucoma. The study uses a phase 1/2 dose-escalation design followed by a masked, randomized, placebo-controlled phase. Insulin is formulated as preservative-free eye drops and delivered once daily. The primary objective is to determine the safety profile of topical insulin; secondary objectives assess effects on retinal structure, visual field, visual acuity, contrast sensitivity, and quality of life.

Conditions

Open Angle Glaucoma; Primary Open Angle Glaucoma; Low Tension Glaucoma; Pigmentary Glaucoma; Pseudoexfoliation Glaucoma

Keywords

glaucoma; neuroprotection; topical insulin; retinal ganglion cell; EYED-002

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of ocular and systemic adverse events (AEs) and serious adverse events (SAEs)

  Safety of topical sterile human insulin (EYED-002) in patients with open-angle glaucoma. AEs and SAEs classified using MedDRA nomenclature, assessed for severity (mild, moderate, severe) and causality. Safety monitoring includes glycemia measurements before and 2 hours after in-clinic insulin administration, and serial serum electrolyte (potassium) measurements.

  From informed consent through end of participation (up to 27 months)

Secondary Outcomes (5)

• Change in retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness by SD-OCT

  Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)

• Change in visual field by Humphrey 24-2 (mean deviation, VFI, pointwise analysis)

  Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)

• Change in best corrected visual acuity (BCVA) by ETDRS

  Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)

• Change in contrast sensitivity by FrACT contrast test

  Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)

• Change in quality of life by GQL-15 questionnaire

  Baseline, 6 months, and 12 months (Group 3)

Study Arms (5)

Group 1: Low-Dose EYED-002

EXPERIMENTAL

N=5 participants with open-angle glaucoma. Low-dose topical insulin (EYED-002), administered as one drop to the study eye once daily in-clinic for 5 consecutive days. Open-label.

Drug: EYED-002 Low Dose (721 U/mL topical insulin)

Group 2: High-Dose EYED-002

EXPERIMENTAL

N=5 participants with open-angle glaucoma. High-dose topical insulin (EYED-002), administered as one drop to the study eye once daily in-clinic for 5 consecutive days.

Drug: EYED-002 High Dose (1442 U/mL topical insulin)

Group 3: Active EYED-002 (Randomized)

EXPERIMENTAL

N=40 participants randomized to active EYED-002 at the highest tolerated dose from Groups 1 or 2, administered once daily at home for 12 months. Double -masked.

Drug: EYED-002 (highest tolerated dose, 12-month)

Group 3: Vehicle Placebo (Randomized)

PLACEBO COMPARATOR

N=20 participants randomized to vehicle-only placebo, administered once daily at home for 12 months. double-masked. Eligible participants may roll over to open-label active EYED-002 for an additional 12 months after Month 12.

Drug: Vehicle Placebo

Group 4: Open-Label Access

EXPERIMENTAL

N=20 participants ineligible for randomization due to glaucoma severity. Receive highest tolerated dose of EYED-002 once daily for 12 months in an open-label access arm.

Drug: EYED-002 (highest tolerated dose, 12-month)

Interventions

EYED-002 Low Dose (721 U/mL topical insulin) DRUG

Sterile, preservative-free suspension of Human Insulin USP. One drop to study eye for duration of study group.

Also known as: Topical Sterile Human Insulin

Group 1: Low-Dose EYED-002

EYED-002 High Dose (1442 U/mL topical insulin) DRUG

Sterile, preservative-free suspension of Human Insulin USP. One drop to study eye once daily in-clinic for duration of study group.

Also known as: Topical Sterile Human Insulin

Group 2: High-Dose EYED-002

EYED-002 (highest tolerated dose, 12-month) DRUG

Highest tolerated dose of EYED-002 (721 U/mL or 1442 U/mL, determined from Groups 1 and 2 safety review). Once daily at home for 12 months in single-use vials, dispensed at quarterly visits.

Also known as: Topical Sterile Human Insulin

Group 3: Active EYED-002 (Randomized); Group 4: Open-Label Access

Vehicle Placebo DRUG

Vehicle-only formulation without active insulin. Single-use vials identical in appearance to active EYED-002. Once daily at home for 12 months.

Also known as: Placebo eye drop

Group 3: Vehicle Placebo (Randomized)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent approved by the appropriate ethics committee
• Age 18 years or older
• Understand study procedures and have the ability and willingness to abide by all procedures during the study
• Capable of providing informed consent
• Diagnosis of glaucoma

You may not qualify if:

• Pregnant or breastfeeding
• Presence of any ocular pathology other than glaucoma that contributes to severe vision loss (retinopathy, maculopathy, severe uveitis, keratopathy, etc.)
• Diagnosis of glucose intolerance, type 1 or type 2 diabetes mellitus
• Inability to perform reliable visual field testing
• Unable to provide informed consent
• Unable to complete the tests and follow-ups required by the study

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Byers Eye Institute at Stanford University

Palo Alto, California, 94303, United States

Location

Related Publications (2)

• Agostinone J, Alarcon-Martinez L, Gamlin C, Yu WQ, Wong ROL, Di Polo A. Insulin signalling promotes dendrite and synapse regeneration and restores circuit function after axonal injury. Brain. 2018 Jul 1;141(7):1963-1980. doi: 10.1093/brain/awy142.

  PMID: 29931057 BACKGROUND

• Saludares M, Wennberg-Smith Z, Beykin G, Khatib TZ, Nunez M, Wang Q, Di Polo A, Goldberg JL. A Phase I Randomized Trial of Topical Insulin for Glaucoma: Safety and Efficacy Outcomes. Ophthalmol Sci. 2025 Dec 6;6(2):101032. doi: 10.1016/j.xops.2025.101032. eCollection 2026 Feb.

  PMID: 41584099 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Low Tension Glaucoma; Exfoliation Syndrome; Glaucoma

Interventions

Insulin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases; Iris Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jeffrey L Goldberg, MD PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Team

CONTACT

650-497-5942; glaucomatrials@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Masking applies to Group 3 only. Participants randomized in Group 3 are masked to treatment assignment (active vs. vehicle placebo). Groups 1, 2, and 4 are open-label.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Ophthalmology

Model Details: The study proceeds sequentially across four groups. Groups 1 and 2 are open-label dose-escalation safety cohorts (N=5 each). Group 3 is a masked, randomized, placebo-controlled parallel group phase (N=60; 2:1 active:placebo). Group 4 is an open-label access arm for patients with advanced disease (N=20). Dose selection for Groups 3 and 4 is based on safety data from Groups 1 and 2.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)