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

NCT01123044 | Unknown Phase 3

• 1 other identifier: CT 09-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Injury

Outcome Measures

Primary Outcomes (6)

• 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

  One week

• 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

  One month

• 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

  Three month

• 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

  Six month

• 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

  Nine month

• 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

  Twelve month

Secondary Outcomes (3)

• Adverse events reporting, vital signs, and physical examinations.

• Maintenance of corneal re-epithelisation with absence of recurrence of surface disease

• Subjective improvement of symptoms

Study Arms (2)

corneal stem cell transplant

EXPERIMENTAL

Biological: conservative

conservative medical therapy

NO INTERVENTION

Biological: conservative; Procedure: Medical Therapy

Interventions

conservative BIOLOGICAL

Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane

conservative medical therapy; corneal stem cell transplant

Medical Therapy PROCEDURE

Under usual care treatment

conservative medical therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ministry of Health, Malaysia: lead

Study Sites (1)

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

MeSH Terms

Conditions

Eye Injuries

Interventions

Conservative Treatment; Nutrition Therapy

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Eye Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: May 14, 2010
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 8, 2011

Record last verified: 2010-05

Locations

MY (1)