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B. H. Jeng, G. Sosne, S. Srivastava, D. M. Marcus, R. C. Gentile, L. Martin, D. Crockford; A Randomized, Double-Mask, Placebo-Controlled, Dose-Response, Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 in the Treatment of Diabetic Patients’ Corneal Wounds Resulting From Epithelial Debridement During Vitrectomy. Invest. Ophthalmol. Vis. Sci. 2010;51(13):383.
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The primary objective of this study was to evaluate the safety and tolerability of Thymosin Beta 4 (Tβ4) ophthalmic solution in diabetic patients with corneal epithelial defects resulting from debridement during vitrectomy surgery. The secondary objective was to evaluate the wound-healing effectiveness of Tβ4 in these patients.
This was a double-mask, placebo-controlled, Phase 2 proof-of-principle study intended to evaluate 3 concentrations of Tβ4 in diabetic patients who required corneal epithelial wound healing treatment following epithelial debridement during vitrectomy surgery. Three groups of patients (based on the Tβ4 dose levels of 0.01%, 0.1%, and 0.3%) were to be enrolled sequentially in a dose-escalation fashion dependent on reaching acceptable safety results at each dose level. Patients within each group were to be randomly assigned to Tβ4 or placebo in a 3:1 ratio, such that each group included 9 patients who received Tβ4 and 3 patients who received placebo. Due to slow patient accrual, the study was terminated after 12 patients completed enrollment in the low dose (0.01%) group.
No serious adverse events (AE) occurred in this study, and no treatment emergent AE were considered probably or definitely related to study treatment. There were no differences in time to wound healing between the Tβ4 and placebo groups (p=0.09). All wounds were found healed for the Tβ4 and placebo treatment groups by Day 11, before the end of the 14-day treatment period.
The Tβ4 0.01% dose studied in this trial was safe and well tolerated, and its safety profile was comparable to placebo. Due to small sample size, no statistically significant differences were observed in efficacy between the active and placebo groups.
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