Trial record 10 of 15 for:    Open Studies | "Facial Injuries"

Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease (CLET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Ministry of Health, Malaysia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ministry of Health, Malaysia
ClinicalTrials.gov Identifier:
NCT01123044
First received: April 22, 2010
Last updated: July 7, 2011
Last verified: May 2010
  Purpose

The aim of the study is to assess if transplantation of cultivated corneal epithelial stem cells could restore vision in patients with severe ocular surface disorder with a favourable safety profile that warrants further comparative study.


Condition Intervention Phase
Eye Injury
Biological: conservative
Procedure: Medical Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Malaysia:

Primary Outcome Measures:
  • Improvement of vision at one week [ Time Frame: One week ] [ Designated as safety issue: No ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line

  • Improvement of vision at one month [ Time Frame: One month ] [ Designated as safety issue: No ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line

  • Improvement of vision at three month [ Time Frame: Three month ] [ Designated as safety issue: No ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line

  • Improvement of vision at six month [ Time Frame: Six month ] [ Designated as safety issue: No ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line

  • Improvement of vision at nine month [ Time Frame: Nine month ] [ Designated as safety issue: No ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line

  • Improvement of vision at twelve month [ Time Frame: Twelve month ] [ Designated as safety issue: No ]
    The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line


Secondary Outcome Measures:
  • Adverse events reporting, vital signs, and physical examinations. [ Designated as safety issue: Yes ]
    To evaluate the safety and tolerability of transplantation of limbal epithelial cells cultured on amniotic membrane for a follow-up period of one year in patients. Safety will be evaluated using adverse events reporting, vital signs, and physical examinations.

  • Maintenance of corneal re-epithelisation with absence of recurrence of surface disease [ Designated as safety issue: No ]
  • Subjective improvement of symptoms [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: August 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: corneal stem cell transplant Biological: conservative
Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane
No Intervention: conservative medical therapy Biological: conservative
Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane
Procedure: Medical Therapy
Under usual care treatment

Detailed Description:

Objectives:

Efficacy:

To determine the efficacy of cultivated corneal epithelial stem cells as a treatment for patients with severe ocular surface disorder.

The corneal limbal epithelial stem cell transplant (CLET) successful outcome will be measured by improvement of vision, maintenance of corneal re-epithelisation with absence of recurrence of surface disease and subjective improvement of symptoms.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or non-pregnant females between 18 and 75 years of age.
  2. Written informed consent obtained from patient or parents/guardian.
  3. Patients with unilateral limbal stem deficiency 2-12 months presenting with any of the following

    • Conjunctivalisation
    • Absence of limbal palisades of Vogts
    • Chronic inflammation
    • Persistent or recurrent corneal epithelial defect
  4. Patients who had 2-12 months of conservative treatment. * Diagnostic criteria for limbal stem cell deficiency are as follows:

    • Symptoms of decreased vision, redness, watering, photophobia and recurrent attacks of pain
    • Triad of signs: conjunctivalisation, neovascularisation and chronic inflammation
    • Stippled appearance of cunjunctivalised cornea with loss of palisades of Vogt
    • Recurrent and persistent epithelial defects
    • Superficial vascularisation, scarring, thick fibrovascular pannus, ulceration, melting and perforation

Exclusion Criteria:

Patients with any of the following are not eligible for enrollment into the study:

  1. Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test.
  2. Participation in any drug trial in which the patient received an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the screening phase of this study.
  3. Those persons directly involved in the conduct of the study.
  4. Any history of severe infection such as hepatitis, renal, gastrointestinal, endocrine or neurological disease.
  5. Evidence of corneal stromal scarring, cataract, macular oedema or scarring, retinal detachment and conjunctival keratinisation
  6. Positive for HIV, Hepatitis B, C and VDRL
  7. History of Pulmonary tuberculosis, hepatitis B,
  8. History of alcohol or substance abuse
  9. History of malignancy within previous 5 years
  10. History of organ transplant
  11. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123044

Locations
Malaysia
Hospital Kuala Lumpur Not yet recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
Contact: Umapathy       thiagesw@yahoo.com   
Principal Investigator: Thiages Umapathy, Dr.         
Sponsors and Collaborators
Ministry of Health, Malaysia
  More Information

No publications provided

Responsible Party: Head Clinical Trial Unit, Clinical Research Centre
ClinicalTrials.gov Identifier: NCT01123044     History of Changes
Other Study ID Numbers: CT 09-01
Study First Received: April 22, 2010
Last Updated: July 7, 2011
Health Authority: Malaysia: Ministry of Health

Additional relevant MeSH terms:
Eye Injuries
Wounds and Injuries
Eye Diseases
Facial Injuries
Craniocerebral Trauma

ClinicalTrials.gov processed this record on August 20, 2014