Trial Outcomes & Findings for A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds (NCT NCT00598871)
NCT ID: NCT00598871
Last Updated: 2015-07-08
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
14 days
Results posted on
2015-07-08
Participant Flow
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.
Prior to randomization, patients needed to meet specific inclusion and exclusion criteria.There was no run-in period.
Participant milestones
| Measure |
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).
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
9
|
|
Overall Study
COMPLETED
|
3
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
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
n=9 Participants
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
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Intent to Treat (ITT), Last Observation Carried Forward (LOCF)
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
Outcome measures
| Measure |
Placebo
n=3 Participants
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
n=9 Participants
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).
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) After Treatment With Thymosin Beta 4 in the Target Eye of Diabetic Patients During Vitrectomy
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Analysis per protocol, ITT (Intent to treat), using LOCF (Last Observation Carried Over)
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)
Outcome measures
| Measure |
Placebo
n=3 Participants
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
n=9 Participants
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).
|
|---|---|---|
|
Number of Participants With Corneal Epithelial Wound Healing at Day 14 (End of Treatment)
|
3 participants
Interval 29.2 to 100.0
|
9 participants
Interval 66.4 to 100.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Active Drug
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=3 participants at risk
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
n=9 participants at risk
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).
|
|---|---|---|
|
Eye disorders
Anterior Chamber Cells
|
100.0%
3/3 • Number of events 3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
66.7%
6/9 • Number of events 6 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Anterior Chamber Flare
|
100.0%
3/3 • Number of events 3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
66.7%
6/9 • Number of events 6 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Conjunctival Haemorrhage
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
77.8%
7/9 • Number of events 7 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Conjunctival oedema
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
66.7%
6/9 • Number of events 6 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Punctate Keratitis
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
55.6%
5/9 • Number of events 5 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Corneal disorder
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
44.4%
4/9 • Number of events 4 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Corneal oedema
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
44.4%
4/9 • Number of events 4 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Eye Pain
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
44.4%
4/9 • Number of events 4 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Corneal Erosion
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
33.3%
3/9 • Number of events 3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Anterior Chamber Fibrin
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Investigations
Corneal Staining
|
66.7%
2/3 • Number of events 2 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
44.4%
4/9 • Number of events 4 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Investigations
Intraocular Pressure Increased
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
33.3%
3/9 • Number of events 3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
22.2%
2/9 • Number of events 2 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Anterior Chamber Inflammation
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Corneal Opacity
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Corneal striae
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Eye oedema
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Iris adhesions
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Ocular Discomfort
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
General disorders
Spatial pain
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
0.00%
0/9 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Injury, poisoning and procedural complications
Procedural pain
|
33.3%
1/3 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
0.00%
0/9 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
11.1%
1/9 • Number of events 1 • Adverse Events (AEs) were collected on a daily basis for the first 14 days and during follow-up at Day 28
AEs were collected daily
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER