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Efficacy and Safety Study of Nexagon for Persistent Corneal Epithelial Defects (NTX-PED-001)

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ClinicalTrials.gov Identifier: NCT01165450
Recruitment Status : Terminated (Drug manufacturer could not supply study drug.)
First Posted : July 19, 2010
Results First Posted : April 20, 2015
Last Update Posted : May 7, 2015
Sponsor:
Collaborator:
FDA Office of Orphan Products Development
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Persistent Corneal Epithelial Defects
Interventions Drug: Nexagon
Drug: Vehicle only
Enrollment 2
Recruitment Details  
Pre-assignment Details 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 The third patient was withdrawn from the trial before randomization because we were notified that the study drug had expired and was no longer available.
Arm/Group Title Overall Study
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Overall Study
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
2 participants were randomized and participated in the study before its premature closure for lack of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Percent Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye
Hide Description 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.
Time Frame 14 ± 1 days
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
Arm/Group Title Overall Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Incidence of Adverse Events Following Application of the Investigational Product in All Subjects
Hide Description 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.
Time Frame 28 ± 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
Arm/Group Title Overall Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Time to Complete Re-epithelialization of the Study Eye
Hide Description 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.
Time Frame 28 ± 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
Arm/Group Title Overall Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Complete Healing of the Corneal Epithelial Defect at Day 14 ± 1 in the Study Eye
Hide Description 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.
Time Frame 14 ± 1 days
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
Arm/Group Title Overall Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change in the Rate of Re-epithelialization of the Study Eye
Hide Description

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.

Time Frame 35 ± 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
Arm/Group Title Overall Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Persistence of Complete Corneal Re-epithelialization in the Study Eye
Hide Description 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.
Time Frame 28 ± 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
Arm/Group Title Overall Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Percent Reduction of Corneal Epithelial Defect at Day 28 ± 2 in the Study Eye
Hide Description 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.
Time Frame 28 ± 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prematurely, data were never analyzed; PI has left the institution and data are no longer available.
Arm/Group Title Overall Study
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study
Hide Arm/Group Description 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.
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall Study
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Overall Study
Affected / at Risk (%)
Total   0/2 (0.00%) 
The study was terminated prematurely due to discontinued supply of study drug, and data were never analyzed; PI has left the institution and data are no longer available.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bennie H. Jeng, MD, MS
Organization: University of Maryland School of Medicine
Phone: 667-214-1111
EMail: bjeng@som.umaryland.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01165450     History of Changes
Other Study ID Numbers: Nex001
1R01FD003708-01A1 ( U.S. FDA Grant/Contract )
First Submitted: July 15, 2010
First Posted: July 19, 2010
Results First Submitted: April 7, 2015
Results First Posted: April 20, 2015
Last Update Posted: May 7, 2015