Topical Insulin for Glaucoma (TING2)

Browse trials for

• Glaucoma, Open-Angle 924
• Low Tension Glaucoma 65
• Exfoliation Syndrome 72
• Glaucoma 1,419

Keywords

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

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 90 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Study arms

• Experimental
  Group 1: Low-Dose EYED-002

  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)

• Experimental
  Group 2: High-Dose EYED-002

  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)

• Experimental
  Group 3: Active EYED-002 (Randomized)

  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)

• Placebo comparator
  Group 3: Vehicle Placebo (Randomized)

  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

• Experimental
  Group 4: Open-Label Access

  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

• DrugEYED-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.

  Also known as: Topical Sterile Human Insulin

• DrugEYED-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.

  Also known as: Topical Sterile Human Insulin

• DrugEYED-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.

  Also known as: Topical Sterile Human Insulin

• DrugVehicle Placebo

  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

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.

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

Secondary outcomes

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

   Change in retinal thickness as measured by spectral domain optical coherence tomography (SD-OCT).

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

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

   Change in visual field as measured by mean deviation, visual field index, and pointwise analysis on Humphrey 24-2 testing.

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

3. Change in best corrected visual acuity (BCVA) by ETDRS

   Change in visual acuity as measured by ETDRS chart.

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

4. Change in contrast sensitivity by FrACT contrast test

   Change in contrast sensitivity as measured by the computer-based FrACT contrast test.

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

5. Change in quality of life by GQL-15 questionnaire

   Change in patient-reported quality of life as measured by the Glaucoma Quality of Life-15 (GQL-15) questionnaire.

   Time frame: Baseline, 6 months, and 12 months (Group 3)

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. PubMed 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. PubMed 41584099 ↗

Individual participant data

Plan to share: No