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

History of Changes

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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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

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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 ]

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2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

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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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

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