Persistent Corneal Epithelial DefectPhase 1/2NCT02979912
Autologous Platelet Lysate in Corneal Epithelial Defects
A Phase 1/2 study testing Platelet Lysate in people with Persistent Corneal Epithelial Defect, run by Hanan Jafar at 1 site in Jordan.
Trial summary
Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous platelet lysate. Read more about this study
- Who is it for?
- Ages 21 to 78 years
- Conditions the study is for
- Persistent Corneal Epithelial Defect
- What is being tested?
- Platelet Lysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJordan
- Study dates
- 16 Feb 2017to 30 Jan 2019
- 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 21 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cognitive ability to understand and sign the consent form.
- Corneal ulcers that did not re-epithelialise after 1 week of conventional treatment (therapeutic contact lenses, topical artificial tears, eye packs and antibiotic eye-drops).
- Clinical indications: corneal ulcer due to caustic substances, corneal epitheliopathy, corneal lesions following cataract surgery, recurrent ulcerative keratitis, corneal lesions due to a foreign body.
- Good compliance with the study regimen and availability for the duration of the entire study period.
Who cannot join
- Corneal ulcers which developed tissue scars.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Autologous Platelet Lysate in Persistent Corneal Epithelial Defects
Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous platelet lysate.
Read the detailed description
Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be taken in multiple doses.
- Conditions
- Persistent Corneal Epithelial Defect
- Being tested
- Platelet Lysate
- Keywords
- Persistent corneal epithelial defect, Platelet Lysate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet LysateBiological
Eye drops of Platelet Lysate
| Study group | Role | What they receive |
|---|---|---|
| Platelet Lysate | Experimental | Autologous platelet lysate dispensed into eye droppers to be applied four times a day for a total of four weeks. Receives: Biological: Platelet Lysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops
Evaluation of the safety and tolerability of PL in the treatment of PED by monitoring any adverse event resulting from the eye drops.
Measured: 2 months
Secondary outcomes (1)
Assessment of the efficacy by clinical judgment
Efficacy of the given eye drops will be clinically evaluated by measuring the degree of healing of the epithelial defect
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start16 Feb 2017
- Primary completion15 Jan 2019
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Corneal Epithelial DefectStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanan Jafar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanan Jafar, University of Jordan
- Investigators
- Abdallah Awidi, MD, Study director, Cell Therapy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979912
- Sponsor's protocol ID
- PEDUJCTC
- Status last verified
- Mar 2021
- First submitted
- 29 Nov 2016
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abu-Ameerh MA, Jafar HD, Hasan MH, Al Bdour MD, Msallam M, Ababneh OH, Alhattab DM, Al-Kurdi B, Awidi AA, Awidi AS. Platelet lysate promotes re-epithelialization of persistent epithelial defects: a pilot study. Int Ophthalmol. 2019 Jul;39(7):1483-1490. doi: 10.1007/s10792-018-0968-1. Epub 2018 Jul 5.
PubMed 29978342
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Autologous Platelet Lysate in Persistent Corneal Epithelial Defects
- ClinicalTrials.gov ID
- NCT02979912
- Acronym / sponsor ID
- PEDUJCTC
- Conditions
- Persistent Corneal Epithelial Defect
- Keywords
- Persistent corneal epithelial defect, Platelet Lysate
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hanan JafarUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 2 Dec 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.
Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous platelet lysate.
Detailed description
Autologous platelet lysate (PL) will be given to patients diagnosed with persistent corneal epithelial ulcers (PED) who are unresponsive to conventional therapy to promote the healing of PED. PL will be dispensed into sterile eye droppers, and these eye droppers will be stored ideally at -20C and thaw once for use, then will be kept in the refrigerator at +4C, to be taken in multiple doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Platelet Lysate | Experimental | Biological: Platelet LysateAutologous platelet lysate dispensed into eye droppers to be applied four times a day for a total of four weeks. |
Who may qualify
- Ages
- 21 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cognitive ability to understand and sign the consent form.
- Corneal ulcers that did not re-epithelialise after 1 week of conventional treatment (therapeutic contact lenses, topical artificial tears, eye packs and antibiotic eye-drops).
- Clinical indications: corneal ulcer due to caustic substances, corneal epitheliopathy, corneal lesions following cataract surgery, recurrent ulcerative keratitis, corneal lesions due to a foreign body.
- Good compliance with the study regimen and availability for the duration of the entire study period.
Key exclusion criteria (2 listed)
- Corneal ulcers which developed tissue scars.
- Pregnant or lactating women.
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 |
|---|---|---|
| Platelet LysateEye drops of Platelet Lysate | Biological | Platelet Lysate |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops
Time frame: 2 months
Evaluation of the safety and tolerability of PL in the treatment of PED by monitoring any adverse event resulting from the eye drops.
1 secondary outcome
Assessment of the efficacy by clinical judgment
Time frame: 6 months
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 3 Mar 2021.
- Derived from this study: PubMed 29978342Abu-Ameerh MA, Jafar HD, Hasan MH, Al Bdour MD, Msallam M, Ababneh OH, Alhattab DM, Al-Kurdi B, Awidi AA, Awidi AS. Platelet lysate promotes re-epithelialization of persistent epithelial defects: a pilot study. Int Ophthalmol. 2019 Jul;39(7):1483-1490. doi: 10.1007/s10792-018-0968-1. Epub 2018 Jul 5.
- Individual participant dataSharing planned: Undecided
Related trials for Persistent Corneal Epithelial Defect
RecruitingPhase 2
Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease
Persistent Corneal Epithelial Defect, Corneal Epithelial Disorders
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of TP-06 for PCED
Persistent Corneal Epithelial Defect
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
Recruiting
Autologous Platelet-rich Plasma in the Treatment of Persistent Epithelial Defects
Persistent Epithelial Defect
RecruitingPhase 4
Comparison of Topical Insulin and Amniotic Membrane Transplant for Persistent Corneal Epithelial Defects
Persistent Corneal Epithelial Defect
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.
Abdallah Awidi, MD study director
Cell Therapy Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Platelet Lysate in people with Persistent Corneal Epithelial Defect, run by Hanan Jafar at 1 site in Jordan.
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 2 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 3 Mar 2021. 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 Jordan. 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 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?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) as a result of the eye drops (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02979912, which also lists 1 linked publication.
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 3 Mar 2021.