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Not yet recruiting NCT07619482

Topical Insulin for Glaucoma (TING2)

Phase I / Phase II Interventional Open Angle Glaucoma Primary Open Angle Glaucoma Low Tension Glaucoma Pigmentary 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: EYED-002 Low Dose (721 U/mL topical insulin), EYED-002 High Dose (1442 U/mL topical insulin), EYED-002 (highest tolerated dose, 12-month), Vehicle Placebo.
Who it may be relevant to
Registry conditions: Open Angle Glaucoma, Primary Open Angle Glaucoma, Low Tension Glaucoma, Pigmentary Glaucoma. Basic parameters: 18 years — 90 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 →

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Official title

A Phase 1/2 Dose Escalation Followed by a Masked, Randomized, Placebo-Controlled Study to Evaluate Topical Insulin for Neuroprotection in Open Angle Glaucoma

Overview

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.

Interventions

  • Drug EYED-002 Low Dose (721 U/mL topical insulin)
    Sterile, preservative-free suspension of Human Insulin USP. One drop to study eye for duration of study group.
  • Drug EYED-002 High Dose (1442 U/mL topical insulin)
    Sterile, preservative-free suspension of Human Insulin USP. One drop to study eye once daily in-clinic for duration of study group.
  • Drug EYED-002 (highest tolerated dose, 12-month)
    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.
  • Drug Vehicle Placebo
    Vehicle-only formulation without active insulin. Single-use vials identical in appearance to active EYED-002. Once daily at home for 12 months.

Primary outcome measures

  • Incidence and severity of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) [Time frame: From informed consent through end of participation (up to 27 months)]
Secondary outcome measures (5)
  • Change in retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness by SD-OCT [Time frame: 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) [Time frame: 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 [Time frame: Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2)]
  • Change in contrast sensitivity by FrACT contrast test [Time frame: 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 [Time frame: Baseline, 6 months, and 12 months (Group 3)]

Eligibility criteria

Limited Inclusion Criteria - All Groups:

  • 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
  • Only one eye per patient will be selected as the study eye; if both eyes meet inclusion criteria, the eye with worse visual acuity and/or visual field will be selected

Limited Exclusion Criteria - All Groups:

  • 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

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
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Byers Eye Institute at Stanford University — Palo Alto

Publications

  • 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
  • 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

Identifiers

NCT: NCT07619482 · 73339

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗