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Trial record 3 of 11 for:    thymosin beta 4

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00598871
Recruitment Status : Terminated (slow recruitment)
First Posted : January 23, 2008
Results First Posted : April 13, 2010
Last Update Posted : July 8, 2015
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
ReGenTree, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes
Interventions Drug: Thymosin Beta 4 (Tβ4)
Other: Placebo
Enrollment 12
Recruitment Details Recruitment started in January 2008 and ended February 2009 using 4 sites (Hospital Medical Centers). Only the first dose group was completed before suspending the trial due to low patient availability.The procedure of debridement was discontinued in most centers, thus making the availability of surgical subject extremely small.
Pre-assignment Details Prior to randomization, patients needed to meet specific inclusion and exclusion criteria.There was no run-in period.
Arm/Group Title Placebo Active Drug
Hide Arm/Group Description Administration 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). Administration 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).
Period Title: Overall Study
Started 3 9
Completed 3 8
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title Placebo Active Drug Total
Hide Arm/Group Description Administration 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). Administration 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). Total of all reporting groups
Overall Number of Baseline Participants 3 9 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 9 participants 12 participants
43.3  (3.1) 51.4  (15.0) 49.4  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 9 participants 12 participants
Female
2
  66.7%
4
  44.4%
6
  50.0%
Male
1
  33.3%
5
  55.6%
6
  50.0%
1.Primary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs) After Treatment With Thymosin Beta 4 in the Target Eye of Diabetic Patients During Vitrectomy
Hide 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
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT), Last Observation Carried Forward (LOCF)
Arm/Group Title Placebo Active Drug
Hide Arm/Group Description:
Administration 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).
Administration 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).
Overall Number of Participants Analyzed 3 9
Measure Type: Number
Unit of Measure: Participants
3 9
2.Secondary Outcome
Title Number of Participants With Corneal Epithelial Wound Healing at Day 14 (End of Treatment)
Hide 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)
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis per protocol, ITT (Intent to treat), using LOCF (Last Observation Carried Over)
Arm/Group Title Placebo Active Drug
Hide Arm/Group Description:
Administration 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).
Administration 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).
Overall Number of Participants Analyzed 3 9
Measure Type: Number
Unit of Measure: participants
3 9
Time Frame Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
Adverse Event Reporting Description AEs were collected daily
 
Arm/Group Title Placebo Active Drug
Hide Arm/Group Description Administration 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). Administration 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).
All-Cause Mortality
Placebo Active Drug
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Active Drug
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Active Drug
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      9/9 (100.00%)    
Eye disorders     
Anterior Chamber Cells  1  3/3 (100.00%)  3 6/9 (66.67%)  6
Anterior Chamber Flare  1  3/3 (100.00%)  3 6/9 (66.67%)  6
Conjunctival Haemorrhage  1  2/3 (66.67%)  2 7/9 (77.78%)  7
Conjunctival oedema  1  1/3 (33.33%)  1 6/9 (66.67%)  6
Punctate Keratitis  1  2/3 (66.67%)  2 5/9 (55.56%)  5
Corneal disorder  1  2/3 (66.67%)  2 4/9 (44.44%)  4
Corneal oedema  1  2/3 (66.67%)  2 4/9 (44.44%)  4
Eye Pain  1  0/3 (0.00%)  0 4/9 (44.44%)  4
Corneal Erosion  1  1/3 (33.33%)  1 2/9 (22.22%)  2
Eyelid oedema  1  0/3 (0.00%)  0 3/9 (33.33%)  3
Anterior Chamber Fibrin  1  1/3 (33.33%)  1 1/9 (11.11%)  1
Anterior Chamber Inflammation  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Corneal epithelium defect  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Corneal Opacity  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Corneal striae  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Eye oedema  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Iris adhesions  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Keratitis  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Ocular Discomfort  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Photophobia  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Vitreous floaters  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Gastrointestinal disorders     
Nausea  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Vomiting  1  0/3 (0.00%)  0 1/9 (11.11%)  1
General disorders     
Spatial pain  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Injury, poisoning and procedural complications     
Post procedural oedema  1  1/3 (33.33%)  1 0/9 (0.00%)  0
Procedural pain  1  1/3 (33.33%)  1 0/9 (0.00%)  0
Investigations     
Corneal Staining  1  2/3 (66.67%)  2 4/9 (44.44%)  4
Intraocular Pressure Increased  1  0/3 (0.00%)  0 3/9 (33.33%)  3
Nervous system disorders     
Headache  1  0/3 (0.00%)  0 2/9 (22.22%)  2
Dizziness  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Psychiatric disorders     
Insomnia  1  0/3 (0.00%)  0 1/9 (11.11%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
RegeneRx (the Sponsor) agreements may vary with individual investigators, but will not prohibit any investigator from publishing. RegeneRx supports the publication of results from all centers of a multi-center trial but requests that reports based on a single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Won S. Yang, President & CEO
Organization: ReGenTree, LLC
Phone: 609-734-4328
EMail: wonsyang@regentreellc.com
Layout table for additonal information
Responsible Party: ReGenTree, LLC
ClinicalTrials.gov Identifier: NCT00598871     History of Changes
Other Study ID Numbers: RGN-DV-201
First Submitted: December 19, 2007
First Posted: January 23, 2008
Results First Submitted: February 22, 2010
Results First Posted: April 13, 2010
Last Update Posted: July 8, 2015