Open Angle GlaucomaPhase 1/2NCT07619482
Topical Insulin for Glaucoma (TING2)
A Phase 1/2 study testing EYED-002 Low Dose (721 U/mL topical insulin), EYED-002 High Dose (1442 U/mL topical insulin) and EYED-002 (highest tolerated dose, 12-month) in people with Open Angle Glaucoma and Primary Open Angle Glaucoma, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Open Angle Glaucoma, Primary Open Angle Glaucoma, Low Tension Glaucoma
- What is being tested?
- EYED-002 Low Dose (721 U/mL topical insulin), EYED-002 High Dose (1442 U/mL topical insulin) and EYED-002 (highest tolerated dose, 12-month)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2026to Oct 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
About this study
Official title: A Phase 1/2 Dose Escalation Followed by a Masked, Randomized, Placebo-Controlled Study to Evaluate Topical Insulin for Neuroprotection in Open Angle Glaucoma
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.
- Conditions
- Open Angle Glaucoma, Primary Open Angle Glaucoma, Low Tension Glaucoma, Pigmentary Glaucoma, Pseudoexfoliation Glaucoma
- Being tested
- EYED-002 Low Dose (721 U/mL topical insulin), EYED-002 High Dose (1442 U/mL topical insulin), EYED-002 (highest tolerated dose, 12-month), Vehicle Placebo
- Keywords
- glaucoma, neuroprotection, topical insulin, retinal ganglion cell, EYED-002
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma, Exfoliation Syndrome, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYED-002 Low Dose (721 U/mL topical insulin)Drug
Also called Topical Sterile Human Insulin
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
Also called Topical Sterile Human Insulin
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
Also called Topical Sterile Human Insulin
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
Also called Placebo eye drop
Vehicle-only formulation without active insulin. Single-use vials identical in appearance to active EYED-002. Once daily at home for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: EYED-002 Low Dose (721 U/mL topical insulin) |
| 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. Receives: Drug: EYED-002 High Dose (1442 U/mL topical insulin) |
| 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. Receives: Drug: EYED-002 (highest tolerated dose, 12-month) |
| 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. Receives: Drug: Vehicle Placebo |
| Group 4: Open-Label Access | Experimental | 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. Receives: Drug: EYED-002 (highest tolerated dose, 12-month) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From informed consent through end of participation (up to 27 months)
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, and 12 months (Group 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start10 Sep 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey L Goldberg, Stanford University
- Investigators
- Jeffrey L Goldberg, MD PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619482
- Sponsor's protocol ID
- 73339
- Status last verified
- Oct 2026
- First submitted
- 26 May 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29931057Saludares 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.
PubMed 41584099