Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT00598871Other idRGN-DV-201

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: slow recruitment

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 2
Enrollment: 12 participants (actual)
Sponsor: ReGenTree, LLC · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Dec 2007
Primary completion: Feb 2009
Completion: Feb 2009
First posted: 23 Jan 2008 (estimated)
Last update posted: 8 Jul 2015 (estimated)
Conditions: Diabetes

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2007200820092010

Ph 2
A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds
NCT00598871
Dec 2007 to Feb 2009
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Thymosin Beta 4 (Tβ4)Drug
PlaceboOther

Arms2

Placebo comparator
2
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).
Active comparator
1
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).

Primary outcomes1

Outcomes the sponsor listed as primary.

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
Registry description
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

Secondary outcomes(1)

Number of Participants With Corneal Epithelial Wound Healing at Day 14 (End of Treatment)
Time frame · 14 days
Registry description
Number of diabetic patients who had undergone epithelial debridement during vitrectomy resulted in complete corneal wound closure of the affected eye at the end of treatment (Day 14)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 14 days

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

Group	Value (Participants)
Placebo	3
Active Drug	9

Secondary and other outcome results(1)

Secondary outcomeNumber· 14 days

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

Group	Value (participants)
Placebo	3
Active Drug	9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
PlaceboAdministration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(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).	–	0 / 3	3 / 3
Active DrugAdministration of 0.01% Tβ4 weight/weight (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).	–	0 / 9	9 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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