drugset / Trial / NCT00598871

A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds

NCT00598871 ↗

Phase 2 Terminated 12 enrolled ReGenTree, LLC PPD Development, LP · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2007-12
Primary completion
2009-02
Completion
2009-02

Outcome

Outcome not reported

Stopped (Enrollment): “slow recruitment”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Thymosin Beta 4 Peptide 0.01 % Other

Indications