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

NCT00598871 | Terminated Phase 2 Results

• 1 other identifier: RGN-DV-201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Diabetes

Keywords

Thymosin beta 4; Corneal wound healing; Vitrectomy; Diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) After Treatment With Thymosin Beta 4 in the Target Eye of Diabetic Patients During Vitrectomy

  Number of participants with Number of Treatment Emergent Adverse Events (TEAEs) in the Target Eye in diabetic patients who had undergone epithelial debridement during vitrectomy and treated with thymosin beta 4

  14 days

Secondary Outcomes (1)

• Number of Participants With Corneal Epithelial Wound Healing at Day 14 (End of Treatment)

  14 days

Study Arms (2)

2

PLACEBO COMPARATOR

There are 2 groups: active drug and placebo. The patients in the placebo arm receive an administration of eyedrops to the affected eye, identical to the active drug but with no thymosin beta 4 (0.00% thymosin beta 4, w/w), 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).

Other: Placebo

1

ACTIVE COMPARATOR

There are 2 groups: active drug and placebo. The patients in the active comparator arm receive an administration of 0.01% Tβ4 (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).

Drug: Thymosin Beta 4 (Tβ4)

Interventions

Thymosin Beta 4 (Tβ4) DRUG

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).

Also known as: Thymosin Beta 4 eye drops, Tβ4 eye drops, RGN-259

1

Placebo OTHER

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).

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• ReGenTree, LLC: lead
• PPD Development, LP: collaborator

Study Sites (5)

United Medical Research Institute

Inglewood, California, 90301, United States

Location

Doheny Eye Institute

Los Angeles, California, 90033, United States

Location

Magruder Eye Institue

Orlando, Florida, 32803, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Western Carolina Retinal Associates, PA

Asheville, North Carolina, 28803, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

thymosin beta(4)

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Won S. Yang, President & CEO
• Organization: ReGenTree, LLC

wonsyang@regentreellc.com

609-734-4328

Study Officials

• David R Crockford

  RegeneRx Biopharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: January 23, 2008
• Study Start: December 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 8, 2015
• Results First Posted: April 13, 2010

Record last verified: 2012-11

Locations

US (5)