Official Title: A Randomized, Double-Mask, Placebo-Controlled, Dose-Response, Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 (Tβ4) in the Treatment of Diabetic Patients' Corneal Epithelial Wounds Resulting from Debridement following Vitrectomy

Purpose: The purpose of this study is to investigate a treatment to enhance healing of diabetic patients with corneal wounds resulting from epithelial debridement during vitrectomy.

Study Type: Phase 2

Study Design: Randomized, double-mask, placebo-controlled, dose response

Locations: U.S., up to 14 sites

Expected Total Enrollment: 48

Targeted Study Completion: Q4 2008

Study Start: Recruiting

ClinicalTrials.gov ID: Not assigned yet

Objectives:

• To evaluate the safety and tolerability of Thymosin Beta 4 (Tβ4) ophthalmic solution administered by drops to the affected eye in diabetic patients with corneal wounds resulting from epithelial debridement during vitrectomy.

• To evaluate the wound healing effectiveness of Tβ4 ophthalmic solution in diabetic patients with corneal wounds resulting from epithelial debridement during vitrectomy.