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

What Was Tested

This registered phase 2 trial tested TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length).

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.

It had two arms (groups): 2 (placebo comparator) and 1 (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

In individuals with certain clinical conditions, such as diabetes, corneal epithelial defects persist and do not necessarily respond to conventional treatment regimens because of delayed epithelial wound healing.

While wound closure should occur following an injury to the corneal epithelium, a timely re-establishment of the epithelial barrier is of utmost importance.

The wound repair process is intricately linked to a complex inflammatory response that must be properly regulated to ensure healing and optimal visual outcome.

Infiltration of inflammatory cells into injured corneal tissue is a hallmark of wound repair, and the association of polymorphonuclear (PMN) leukocyte infiltration with sterile corneal ulceration is well recognized.

Who Took Part

12 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 1 or Type 2 diabetes mellitus. Signed written informed consent by patient or legal guardian.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: have current or history of herpetic eye disease in the past 3 years; display evidence of keratitis; have sjögren's syndrome.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the TB-500 (Thymosin Beta-4 fragment) group and the comparison group should start out alike.

The TB-500 (Thymosin Beta-4 fragment) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on TB-500 (Thymosin Beta-4 fragment), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2007-12 with completion listed for 2009-02.

It ran at 5 sites in United States (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Treatment Emergent Adverse Events (TEAEs) After Treatment With Thymosin Beta 4 in the Target Eye of Diabetic Patients During Vitrectomy (time frame: 14 days).

It also tracked 1 secondary outcome, for example Number of Participants With Corneal Epithelial Wound Healing at Day 14 (End of Treatment).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of TB-500 (Thymosin Beta-4 fragment) and Thymosin Beta-4 (full length) in 12 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the TB-500 (Thymosin Beta-4 fragment) compound page and the Thymosin Beta-4 (full length) compound page, all human trials.