Eye InjuryPhase 3CLETNCT01123044
Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease
A Phase 3 study testing conservative and Medical Therapy in people with Eye Injury, run by Ministry of Health, Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eye Injury
- What is being tested?
- conservative and Medical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteMalaysia
- Study dates
- Aug 2011to Sep 2012
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586
Umapathy, thiagesw@yahoo.com
Thiages Umapathy, Dr.
About this study
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.
Read the 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.
- Conditions
- Eye Injury
- Being tested
- conservative, Medical Therapy
- Medical subject headings
- Eye Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservativeBiological
Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane
Medical TherapyProcedure or surgery
Under usual care treatment
| Study group | Role | What they receive |
|---|---|---|
| corneal stem cell transplant | Experimental | Not described Receives: Biological: conservative |
| conservative medical therapy | No intervention | Not described Receives: Biological: conservative; Procedure: Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Twelve month
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2010 (estimated)
- Study startAug 2011
- Primary completionJun 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01123044
- Sponsor's protocol ID
- CT 09-01
- Acronym
- CLET
- Status last verified
- May 2010
- First submitted
- 22 Apr 2010
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Cultivated Corneal Epithelial Sheet in Patients With Ocular Surface Disease
- ClinicalTrials.gov ID
- NCT01123044
- Acronym / sponsor ID
- CLET / CT 09-01
- Conditions
- Eye Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 14 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| corneal stem cell transplant | Experimental | Biological: conservative |
| conservative medical therapy | No intervention | Biological: conservative, Procedure: Medical Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Patients who had 2-12 months of conservative treatment. * Diagnostic criteria for limbal stem cell deficiency are as follows:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conservativeUndergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane | Biological | conservative medical therapy, corneal stem cell transplant |
| Medical TherapyUnder usual care treatment | Procedure or surgery | conservative medical therapy |
Primary outcome
Improvement of vision at one week
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
3 secondary outcomes
Adverse events reporting, vital signs, and physical examinations.
Maintenance of corneal re-epithelisation with absence of recurrence of surface disease
Subjective improvement of symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing conservative and Medical Therapy in people with Eye Injury, run by Ministry of Health, Malaysia at 1 site in Malaysia.
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 13 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of vision at one week (time frame: One week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2011.