Cornea InjuryPhase 1/2NCT02746848
Utilization of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Healing
A Phase 1/2 study testing Amniotic Membrane Extract Eye Drop in people with Cornea Injury, run by Royan Institute.
Trial summary
For severe ocular surface diseases, such as chemical and thermal injuries, Stevens-Johnson syndrome (SJS), Band Keratopathy, Corneal Dystrophies, Refractive (PRK-LASEK), corneal surgery and others, it is important that short time treatment with minimal side effect should be considered. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cornea Injury
- What is being tested?
- Amniotic Membrane Extract Eye Drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Nov 2015
- Phase
- Phase 1/2
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient with corneal epithelium injury
- Without keratoconus
- Without cornea scar
- Without any other lesion of cornea
Who cannot join
- Lack of timely referral of patients for examinations
- Simultaneous use of other drugs that cause impairment of the data
- Previous cornea surgery
- Dry eye
- Glaucoma
About this study
Official title: Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)
For severe ocular surface diseases, such as chemical and thermal injuries, Stevens-Johnson syndrome (SJS), Band Keratopathy, Corneal Dystrophies, Refractive (PRK-LASEK), corneal surgery and others, it is important that short time treatment with minimal side effect should be considered. This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing
Read the detailed description
The cornea is the specific anterior part of eye that is essential for normal vision. The corneal surface is comprised of a unique type of non-keratinized epithelial cell. Corneal epithelium contains transient amplifying cells and post mitotic cells. The limbal stem cells (LSC) are located between limbal cornea and conjunctiva which are main source of corneal epithelium healing in eye injuries. For some corneal disease such as chemical and thermal injuries, Corneal Dystrophies and corneal surgery, treatment in short time is important.
AM can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. This biological substrate maintain epithelial progenitor cells within the limbal stem cell niche and facilitate ocular surface epithelial renewal. It is well accepted that amniotic membrane Transplantation (AMT) as a temporary patch normally dissolves within 2 weeks. Consequent reapplication of membrane is difficult for the patient.
Other studies have been reported that processed AM as a liquid has comparable effect to AMT in treatment of corneal epithelial healing.
This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing.
- Conditions
- Cornea Injury
- Being tested
- Amniotic Membrane Extract Eye Drop
- Keywords
- cornea epithelium healing Amniotic Membrane Eye Drop
- Medical subject headings
- Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic Membrane Extract Eye DropBiological
Amniotic Membrane Extract use as eye drop for patients with corneal injury.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cornea injury | Experimental | Patients with cornea injury who received healing Amniotic Membrane Extract Eye Drop. Receives: Biological: Amniotic Membrane Extract Eye Drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal defect size
Evaluation the corneal defect size (millimeter) by microscope after corneal surgery and compare the change of defect size after procedure in compare with base line (before surgery).
Measured: 12 months
Secondary outcomes (2)
Eye Discharge
Evaluation the presence of any abnormal discharge from treated eye after procedure based on side effect questionnaire that fill with patients.
Measured: 1 week
pain
Evaluation of any presence of pain in treated eye after procedure based on side effect questionnaire that fill with patients.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cornea 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteMarzieh Ebrahimi, PhD, Study director, Department of Regenerative Biomedicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.Khosro Jadidi, MD, Study director, Bina Hospital, Research & Education Center, Tehran, IranFatemeh Doostmohammadi, MD, Principal investigator, Bina Hospital, Research & Education Center, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746848
- Sponsor's protocol ID
- Royan-Eye-003
- Status last verified
- Jan 2016
- First submitted
- 10 Apr 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Amniotic Membrane Extract Eye Drop (AMEED) on Human Corneal Epithelium Healing (Phase I and II Clinical Trial)
- ClinicalTrials.gov ID
- NCT02746848
- Acronym / sponsor ID
- Royan-Eye-003
- Conditions
- Cornea Injury
- Keywords
- cornea epithelium healing Amniotic Membrane Eye Drop
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Apr 2016 (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.
For severe ocular surface diseases, such as chemical and thermal injuries, Stevens-Johnson syndrome (SJS), Band Keratopathy, Corneal Dystrophies, Refractive (PRK-LASEK), corneal surgery and others, it is important that short time treatment with minimal side effect should be considered. This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing
Detailed description
The cornea is the specific anterior part of eye that is essential for normal vision. The corneal surface is comprised of a unique type of non-keratinized epithelial cell. Corneal epithelium contains transient amplifying cells and post mitotic cells. The limbal stem cells (LSC) are located between limbal cornea and conjunctiva which are main source of corneal epithelium healing in eye injuries. For some corneal disease such as chemical and thermal injuries, Corneal Dystrophies and corneal surgery, treatment in short time is important.
AM can modulate corneal epithelium healing by promoting re-epithelialization and migration of limbal stem cell while suppressing stromal inflammation, angiogenesis and scarring. This biological substrate maintain epithelial progenitor cells within the limbal stem cell niche and facilitate ocular surface epithelial renewal. It is well accepted that amniotic membrane Transplantation (AMT) as a temporary patch normally dissolves within 2 weeks. Consequent reapplication of membrane is difficult for the patient.
Other studies have been reported that processed AM as a liquid has comparable effect to AMT in treatment of corneal epithelial healing.
This study is a prospective clinical trial to use Amniotic Membrane Extract Eye Drop (AMEED) as a natural substance for acceleration of corneal healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cornea injury | Experimental | Biological: Amniotic Membrane Extract Eye DropPatients with cornea injury who received healing Amniotic Membrane Extract Eye Drop. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient with corneal epithelium injury
- Without keratoconus
- Without cornea scar
- Without any other lesion of cornea
Key exclusion criteria (5 listed)
- Lack of timely referral of patients for examinations
- Simultaneous use of other drugs that cause impairment of the data
- Previous cornea surgery
- Dry eye
- Glaucoma
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 |
|---|---|---|
| Amniotic Membrane Extract Eye DropAmniotic Membrane Extract use as eye drop for patients with corneal injury. | Biological | Patients with cornea injury |
Primary outcome
corneal defect size
Time frame: 12 months
Evaluation the corneal defect size (millimeter) by microscope after corneal surgery and compare the change of defect size after procedure in compare with base line (before surgery).
2 secondary outcomes
Eye Discharge
Time frame: 1 week
pain
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cornea Injury
Recruiting
Corneal Trauma Diagnostic Study
Ocular Trauma
RecruitingPhase 2
Lacripep for Corneal Wound Healing Study
Corneal Epithelial Wound Healing
Not yet recruiting
IN PATIENTS WITH CORNEAL ABRASIONS TREATED WITH COLLAGEN CORNEAL SHIELDS IN THE EMERGENCY DEPARTMENT SETTING
Corneal Abrasions
Recruiting
Losartan for Corneal Fibrosis
Corneal Scarring Fibrosis
Not yet recruiting
Eyelid Taping Alone Versus Taping With Lubricant Eye Drops for Perioperative Corneal Protection
Corneal Injury, Exposure Keratopathy
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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Marzieh Ebrahimi, PhD study director
Department of Regenerative Biomedicine at Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Khosro Jadidi, MD study director
Bina Hospital, Research & Education Center, Tehran, Iran
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Amniotic Membrane Extract Eye Drop in people with Cornea Injury, run by Royan Institute.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal defect size (time frame: 12 months). 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 21 Apr 2016.