Topical Insulin for Glaucoma (TING2)

Phase 2Not Yet RecruitingNCT07619482

Stanford University90 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

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

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.

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.

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.

Vehicle PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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)

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)

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)

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)

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)

Topical Insulin for Glaucoma (TING2)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts