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

Primary Purpose

Eye Injury

Status
Unknown status
Phase
Phase 3
Locations
Malaysia
Study Type
Interventional
Intervention
conservative
Medical Therapy
Sponsored by
Ministry of Health, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Kuala Lumpur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

corneal stem cell transplant

conservative medical therapy

Arm Description

Outcomes

Primary Outcome Measures

Improvement of vision at one week
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
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
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
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
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
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.
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
Subjective improvement of symptoms

Full Information

First Posted
April 22, 2010
Last Updated
July 7, 2011
Sponsor
Ministry of Health, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT01123044
Brief Title
Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease
Acronym
CLET
Official Title
Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Malaysia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
corneal stem cell transplant
Arm Type
Experimental
Arm Title
conservative medical therapy
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
conservative
Intervention Description
Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane
Intervention Type
Procedure
Intervention Name(s)
Medical Therapy
Intervention Description
Under usual care treatment
Primary Outcome Measure Information:
Title
Improvement of vision at one week
Description
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line
Time Frame
One week
Title
Improvement of vision at one month
Description
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line
Time Frame
One month
Title
Improvement of vision at three month
Description
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line
Time Frame
Three month
Title
Improvement of vision at six month
Description
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line
Time Frame
Six month
Title
Improvement of vision at nine month
Description
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line
Time Frame
Nine month
Title
Improvement of vision at twelve month
Description
The primary efficacy variable will be improved visual acuity Vision will be assessed using ETDRS logMAR visual acuity measurements. An improvement of > 1 line
Time Frame
Twelve month
Secondary Outcome Measure Information:
Title
Adverse events reporting, vital signs, and physical examinations.
Description
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.
Title
Maintenance of corneal re-epithelisation with absence of recurrence of surface disease
Title
Subjective improvement of symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant females between 18 and 75 years of age. Written informed consent obtained from patient or parents/guardian. 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 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: 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. 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. Those persons directly involved in the conduct of the study. Any history of severe infection such as hepatitis, renal, gastrointestinal, endocrine or neurological disease. Evidence of corneal stromal scarring, cataract, macular oedema or scarring, retinal detachment and conjunctival keratinisation Positive for HIV, Hepatitis B, C and VDRL History of Pulmonary tuberculosis, hepatitis B, History of alcohol or substance abuse History of malignancy within previous 5 years History of organ transplant 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.
Facility Information:
Facility Name
Hospital Kuala Lumpur
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
50586
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umapathy
Email
thiagesw@yahoo.com
First Name & Middle Initial & Last Name & Degree
Thiages Umapathy, Dr.

12. IPD Sharing Statement

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

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