A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds
Condition: Diabetes
Intervention: Thymosin Beta 4 (Tβ4); Placebo
Intervention description: There are 2 groups: active drug and placebo. The patients in the active arm receive an administration of 0.01% Tβ4 (w/w) eyedrops to the affected eye, 2 drops 4 times daily (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).; There are 2 groups: active drug and placebo. The patients in the placebo arm receive an administration of 0.00% Tβ4(w/w) eyedrops to the affected eye, 2 drops four times a day (QID) (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Thymosin beta 4; Corneal wound healing; Vitrectomy; Diabetes

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.
    

Eligibility criteria:

        Inclusion Criteria

          -  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.

        Exclusion Criteria

          -  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.