Trial Outcomes & Findings for Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial Defects (NCT NCT01165450)
NCT ID: NCT01165450
Last Updated: 2015-05-07
Results Overview
Primary efficacy measure: To determine whether topical treatment of persistent epithelial defects with Nexagon preparations yields greater healing at Day 14 ± 1, compared to vehicle alone, in individuals having had diabetic vitrectomy. Healing will be determined by comparing pseudo-area (as measured by Investigator, or designated ophthalmologist) at baseline (taken just prior to the first treatment) and Day 14 ± 1. Pseudo-area is defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter.
TERMINATED
PHASE2
2 participants
14 ± 1 days
2015-05-07
Participant Flow
3 patients were enrolled but only 2 randomized. The third patient was withdrawn from the trial before randomization because we were notified that the study drug had expired and was no longer available.
Participant milestones
| Measure |
Overall Study
We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
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|---|---|
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Overall Study
STARTED
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2
|
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Overall Study
COMPLETED
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2
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Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial Defects
Baseline characteristics by cohort
| Measure |
Overall Study
n=2 Participants
We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 ± 1 daysPopulation: The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
Primary efficacy measure: To determine whether topical treatment of persistent epithelial defects with Nexagon preparations yields greater healing at Day 14 ± 1, compared to vehicle alone, in individuals having had diabetic vitrectomy. Healing will be determined by comparing pseudo-area (as measured by Investigator, or designated ophthalmologist) at baseline (taken just prior to the first treatment) and Day 14 ± 1. Pseudo-area is defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 28 ± 2 daysPopulation: The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
Primary safety measure: To determine incidence of adverse events by recording their occurrence at each study visit through Day 28 ± 2. Analysis of safety data will be performed prior to each dose-escalation. If greater than 2 serious adverse events are found that are causally related to the investigational product, the study will be halted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 ± 2 daysPopulation: The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
Resolution of epithelial defect is defined as the largest diameter of the epithelial defect being less than 0.5 mm, as it is difficult to distinguish a smaller defect from the small amount of fluorescing staining seen in a healed defect. Time of complete re-epithelialization will be defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 14 ± 1 daysPopulation: The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
To determine binary indicator of whether or not healing has occurred at 14 ± 1 days, defined as the largest diameter of the epithelial defect being smaller than 0.5 mm as determined by slit lamp examination with fluorescein staining.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 35 ± 2 daysPopulation: The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
To determine the change in the rate of re-epithelialization of the study eye from the screening run-in period to the treatment period, if applicable. Time Frame: Screening period is defined as Day -7 to Day 0 ± 1. Treatment period is defined as Day 0 ± 1 through time of complete re-epithelialization. Time of complete re-epithelialization is defined as the midpoint between the last observed date with an epithelial defect and the date of the first visit with no epithelial defect, up to Day 28 ± 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 ± 2 daysPopulation: The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
To determine whether or not complete corneal re-epithelialization was persistent, as determined by whether the healed epithelium remains intact after complete re-epithelialization is confirmed in the study eye. The measurement will be made at Day 28 ± 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 ± 2 daysPopulation: The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
To compare, in each of the two patient populations, the percent reduction in epithelial defect size at Day 28 ± 2 compared to baseline, as measured by slit lamp examination with fluorescein staining. Epithelial defect size determined by pseudo-area, defined by the longest diameter of the lesion multiplied by the longest perpendicular to this longest diameter.
Outcome measures
Outcome data not reported
Adverse Events
Overall Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bennie H. Jeng, MD, MS
University of Maryland School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place