Low Tension Glaucoma, Open Angle Glaucoma, Pigmentary Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Conditions
Keywords
glaucoma, neuroprotection, topical insulin, retinal ganglion cell, EYED-002
Brief summary
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
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.
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.
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.
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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of ocular and systemic adverse events (AEs) and serious adverse events (SAEs) | From informed consent through end of participation (up to 27 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) thickness by SD-OCT | Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2) | Change in retinal thickness as measured by spectral domain optical coherence tomography (SD-OCT). |
| Change in visual field by Humphrey 24-2 (mean deviation, VFI, pointwise analysis) | Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2) | Change in visual field as measured by mean deviation, visual field index, and pointwise analysis on Humphrey 24-2 testing. |
| Change in best corrected visual acuity (BCVA) by ETDRS | Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2) | Change in visual acuity as measured by ETDRS chart. |
| Change in contrast sensitivity by FrACT contrast test | Baseline to 12 months (Groups 3 and 4); Baseline to Day 5 (Groups 1 and 2) | Change in contrast sensitivity as measured by the computer-based FrACT contrast test. |
| Change in quality of life by GQL-15 questionnaire | Baseline, 6 months, and 12 months (Group 3) | Change in patient-reported quality of life as measured by the Glaucoma Quality of Life-15 (GQL-15) questionnaire. |
Countries
United States
Contacts
CONTACTStudy Team
PRINCIPAL_INVESTIGATORJeffrey L Goldberg, MD PhD
Stanford University
Outcome results
None listed