A Phase 1/2 Dose Escalation Followed by a Masked, Randomized, Placebo-Controlled Study to Evaluate Topical Insulin for Neuroprotection in Open Angle Glaucoma

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.

Eligibility

Age range

18–90 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  EYED-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.

• Drug
  EYED-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.

• Drug
  EYED-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.

• Drug
  Vehicle Placebo

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

Location