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Persistent Epithelial DefectPhase 2NCT00821561

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

A Phase 2 study testing Nexagon® in people with Persistent Epithelial Defect, run by OcuNexus Therapeutics, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Persistent Epithelial Defect
What is being tested?
Nexagon®
How many people
90 participants
Where
No sites listed yet
Study dates
Mar 2009to Mar 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 16Show fewer
  • 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.
  • Subjects who have more than one distinct PED in the study eye.

About this study

Official title: A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Nexagon® in Subjects With Persistent Corneal Epithelial Defects (PED) From Chemical Burn Injuries.

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.

Being tested
Nexagon®, Nexagon® vehicle
Keywords
Persistent, cornea, defect, Nexagon, Coda
Medical subject headings
Corneal Diseases, Cavitary Optic Disc Anomalies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nexagon®Drug

  • Nexagon® vehicleDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionNov 2009 (estimated)
  4. Study completionMar 2010 (estimated)

Why it stopped: Withdrawn prior to recruitment for business reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00821561
Sponsor's protocol ID
NEX-PED-001
Status last verified
Feb 2010
First submitted
10 Jan 2009
Last updated
26 Feb 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nexagon® in people with Persistent Epithelial Defect, run by OcuNexus Therapeutics, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 26 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary objective of this study is to evaluate the efficacy and safety of Nexagon® as a treatment for PED from chemical burn injuries.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00821561.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2010.

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