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

This study has been terminated.
(slow recruitment)
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00598871
First received: December 19, 2007
Last updated: December 5, 2012
Last verified: November 2012
Results First Received: February 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes
Interventions: Drug: Thymosin Beta 4 (Tβ4)
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to randomization, patients needed to meet specific inclusion and exclusion criteria.There was no run-in period.

Reporting Groups
  Description
Placebo 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).
Active Drug 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).

Participant Flow:   Overall Study
    Placebo     Active Drug  
STARTED     3     9  
COMPLETED     3     8  
NOT COMPLETED     0     1  
Adverse Event                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo 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).
Active Drug 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 Total of all reporting groups

Baseline Measures
    Placebo     Active Drug     Total  
Number of Participants  
[units: participants]
  3     9     12  
Age  
[units: years]
Mean ± Standard Deviation
  43.3  ± 3.1     51.4  ± 15.0     49.4  ± 13.4  
Gender  
[units: participants]
     
Female     2     4     6  
Male     1     5     6  



  Outcome Measures
  Show All Outcome Measures

1.  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 ]

2.  Secondary:   Number of Participants With Corneal Epithelial Wound Healing at Day 14 (End of Treatment)   [ Time Frame: 14 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: NabilaTurjman, PhD, Executive Director, Regulatory Affairs & Drug Safety
Organization: RegeneRx Biopharmaceuticals, Inc.
phone: 301-208-9191 ext 108
e-mail: nturjman@regenerx.com


No publications provided


Responsible Party: RegeneRx Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00598871     History of Changes
Other Study ID Numbers: RGN-DV-201
Study First Received: December 19, 2007
Results First Received: February 22, 2010
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration