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

Phase 3

• Conditions: Eye Injury
• Interventions: Biological: conservative; Procedure: Medical Therapy

• Registration Number: NCT01123044
• Lead Sponsor: Ministry of Health, Malaysia

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.

Study Timeline

• Study First Submitted: 2010-04-22
• Status Verified: 2010-05
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-14
• Last Update Submitted: 2011-07-07
• Last Update Posted: 2011-07-08
• Study Start: 2011-08
• Primary Completion: 2012-06
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
corneal stem cell transplant	conservative	-
conservative medical therapy	conservative	-
conservative medical therapy	Medical Therapy	-

Primary Outcome Measures

Name	Time	Method
Improvement of vision at one week	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	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	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	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	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	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

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Kuala Lumpur; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia