Health TrialsbyHealthPanel

Topical Insulin for Glaucoma (TING2)

ConditionsOpen Angle GlaucomaPrimary Open Angle GlaucomaLow Tension GlaucomaPigmentary GlaucomaPseudoexfoliation Glaucoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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 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.

Treatment groups

90 Participants
are divided into 5 treatment groups
Group A: Group 1: Low-Dose EYED-002Experimental treatment 1 intervention
Group B: Group 2: High-Dose EYED-002Experimental treatment 1 intervention
Group C: Group 3: Active EYED-002 (Randomized)Experimental treatment 1 intervention
Group D: Group 3: Vehicle Placebo (Randomized)Placebo comparator 1 intervention
Group E: Group 4: Open-Label AccessExperimental treatment 1 intervention

Trial outcomes

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: