A Study to Investigate the Safety and Clinical Effect of Nexagon® to Treat Persistent Epithelial Defects

NCT00821561 | Withdrawn Phase 2

• 1 other identifier: NEX-PED-001
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Nexagon® in subjects with Persistent Epithelial Defects (PED) originally caused by chemical burns.

Conditions

Persistent Epithelial Defect

Keywords

Persistent; cornea; defect; Nexagon; Coda

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to evaluate the efficacy and safety of Nexagon® as a treatment for PED from chemical burn injuries.

Interventions

Nexagon® DRUG

Nexagon® vehicle DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged 18 years and over.
• Subjects who are able to attend all follow-up visits and who are able to comply with all study procedures.
• Subjects who are willing and able to give written informed consent to take part in the study.
• At the Day -7 visit subjects must have a corneal epithelial defect that has persisted for between 7 days and 14 days, which has a minimum diameter of 2 mm along the greatest axis, and which has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
• The original defect to the cornea must have been caused by either alkaline or acidic agents.

You may not qualify if:

• Use of concomitant ocular medications in the screening period that are not specified in standardized PED treatment regime
• Likely to require the use of concomitant ocular medications that are not specified in the standardized PED treatment regime during the study follow-up period
• Decrease or increase in the PED by more than 30% during the screening period.
• Have an active lid or ocular infectious process of any sort
• Subjects with corneal perforation or impending corneal perforation
• The circumference affected by limbal blood vessel ischemia is greater than 75% of the circumference
• Subjects with severe lid abnormalities contributory to the persistence of the PED such as inability to close the lids.
• Subjects with bilateral PED, if the smaller PED has a longest diameter of \> 2 mm.
• Female subjects who are pregnant or breastfeeding. F
• Subjects who have a history of AIDS or HIV.
• Subjects with any other condition which, in the Investigator's opinion, would exclude the subject from participating.
• Treatment with systemic corticosteroids (equivalent to \> 10 mg/day of prednisone) or immunosuppressive or chemotherapeutic agents within 7 days prior to Day 0, or likely to receive one of these therapies during study participation
• Subjects who have participated in a clinical trial within 30 days prior to Day 0.
• Diabetics with an HbA1c greater than 6.5%.
• Diabetics who are currently prescribed more than one oral medication for their diabetes.

Sponsors & Collaborators

• OcuNexus Therapeutics, Inc.: lead

MeSH Terms

Conditions

Corneal Diseases; Cavitary Optic Disc Anomalies

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 10, 2009
• First Posted: January 13, 2009
• Study Start: March 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: March 1, 2010
• Last Updated: February 26, 2010

Record last verified: 2010-02