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G. Sosne, S. Dunn, D. Heidemann, C. Chow; The Use of Thymosin Beta 4 to Promote Healing of Neurotrophic Corneal Ulcers. Invest. Ophthalmol. Vis. Sci. 2009;50(13):3491.
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To evaluate the efficacy of topical thymosin beta 4 in the management of chronic non-healing neurotrophic corneal ulceration
A compassionate usage IND from the FDA and subsequent approval of the Wayne State University School of Medicine Investigational Review Board were obtained. Subsequently, four patients (n=4 eyes total) (age range 47-84) with non-healing neurotrophic (Diabetic Keratopathy and Herpes Zoster Ophthalmicus) corneal ulcers of at least 6 weeks duration or longer were enrolled in a compassionate usage treatment protocol adding topically administered thymosin beta 4 eye drops to their previous therapeutic regimen four times daily for 28 days and were subsequently followed clinically for an additional 30 days. Changes in the ulcer size (epithelial defect), depth (corneal thinning), and associated vascularization were measured by slit lamp, fluorescein staining and photographic examination methods. In addition, subjective levels of patient comfort were monitored during the 28 day treatment period and additional 30 day follow-up period.
All ulcers (initially measuring 0.5, 2.0, 10.5 and 12.6 mm2 respectively) showed dramatic and clinically significant reduction in size during the 28 day treatment period with two ulcers being healed completely at 58 days and the others measuring 0.3 mm2 and 0.1 mm2 respectively. No progressive stromal thinning was seen in any of the eyes. Minimal increased superficial vascularization was noted in two patients that had extensive pre-existing (prior to initiation of therapy) neovascularized corneas, although this was not considered significant clinically. The thymosin beta 4 eye drops were well tolerated in all patients without any adverse side effects noted. Additionally, all patients reported markedly reduced associated ocular irritation while under therapy.
Results from these four compassionate usage patients demonstrate that topical thymosin beta 4 shows promise as a novel wound healing therapy in the management of chronic non-healing neurotrophic ulcers and appears to be well tolerated.
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