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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Group 4: Open-Label Access | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) |
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Limited Inclusion Criteria - All Groups:
Limited Exclusion Criteria - All Groups:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Team | Contact | 650-497-5942 | glaucomatrials@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Goldberg, MD PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Byers Eye Institute at Stanford University | Palo Alto | California | 94303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29931057 | Background | 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. | |
| 41584099 | 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. |
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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.
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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.
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.
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| 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. |
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| 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. |
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| 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. |
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Change in visual field as measured by mean deviation, visual field index, and pointwise analysis on Humphrey 24-2 testing. |
| 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 | Change in visual acuity as measured by ETDRS chart. | Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2) |
| Change in contrast sensitivity by FrACT contrast test | Change in contrast sensitivity as measured by the computer-based 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 | Change in patient-reported quality of life as measured by the Glaucoma Quality of Life-15 (GQL-15) questionnaire. | Baseline, 6 months, and 12 months (Group 3) |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D057066 | Low Tension Glaucoma |
| D017889 | Exfoliation Syndrome |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009901 | Optic Nerve Diseases |
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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