Topical Insulin for Glaucoma (TING2)

Stanford University

Status and phase: Not yet enrolling; Phase 2; Phase 1

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

Treatments: Drug: Vehicle Placebo; Drug: EYED-002 Low Dose (721 U/mL topical insulin); Drug: EYED-002 (highest tolerated dose, 12-month); Drug: EYED-002 High Dose (1442 U/mL topical insulin)

Study type: Interventional

Funder types: Other

Identifiers

NCT07619482

73339

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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90 participants in 5 patient groups, including a placebo group

Group 1: Low-Dose EYED-002

Experimental group

Description:

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.

Treatment:

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

Group 2: High-Dose EYED-002

Experimental group

Description:

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.

Treatment:

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

Group 3: Active EYED-002 (Randomized)

Experimental group

Description:

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.

Treatment:

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

Group 3: Vehicle Placebo (Randomized)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Vehicle Placebo

Group 4: Open-Label Access

Experimental group

Description:

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.

Treatment:

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