A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Diabetes
In brief
As a consequence of damage to multiple organ systems throughout the course of their disease, diabetic patients suffer a number of chronic complications giving rise to increased morbidity, mortality, and health care costs specific to this population. Within the ophthalmic domain, diabetic retinopathy (DR) frequently induces serious visual impairment. Although DR can be addressed surgically, surgery remains a less than ideal intervention within this population with a well-characterized compromised ability to heal. The introduction of a therapeutic agent that could accelerate wound closure and decrease healing time, thereby reducing the risk and incidence of infection and corneal scarring in these susceptible patients, would represent a significant clinical and pharmacoeconomic advance in the treatment of this condition.
Key facts
- Study ID
- NCT00598871
- Run by
- ReGenTree, LLC
- People needed
- 12
- Starts
- 2007-12-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2015-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Type 1 or Type 2 diabetes mellitus.
- Patients who have an expected minimum 50% likelihood of requiring corneal epithelial debridement in the opinion of the Investigator Size of wound should be 8 mm.
- Signed written informed consent by patient or legal guardian.
You may not qualify if…
- Have current or history of herpetic eye disease in the past 3 years.
- Display evidence of keratitis.
- Have Sjögren's syndrome.
- Have corneal scarring, opacity, or dystrophy.
- Have a history of malignancy.
- Have a history of HIV or AIDs
- Are pregnant or lactating females.
- Are females who can become pregnant.
- Have a known hypersensitivity to the study drug.
- May be regarded as unreliable for the study.
- Have previously participated in this study.
- Experience any complication during the vitrectomy procedure itself, which will exclude the patient from participating in this study.
Where it is running
- United Medical Research Institute — Inglewood, California, United States
- Doheny Eye Institute — Los Angeles, California, United States
- Magruder Eye Institue — Orlando, Florida, United States
- Southeast Retina Center — Augusta, Georgia, United States
- Western Carolina Retinal Associates, PA — Asheville, North Carolina, United States
Full record on ClinicalTrials.gov
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