NCT02979912

Brief Summary

Patients diagnosed with persistent corneal epithelial ulcers will be treated with autologous platelet lysate.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2017

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 16, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.9 years

First QC Date

November 29, 2016

Last Update Submit

March 2, 2021

Conditions

Persistent Corneal Epithelial Defect

Keywords

Persistent corneal epithelial defectPlatelet Lysate

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Secondary Outcomes (1)

  • Assessment of the efficacy by clinical judgment

    6 months

Study Arms (1)

Platelet Lysate

EXPERIMENTAL

Autologous platelet lysate dispensed into eye droppers to be applied four times a day for a total of four weeks.

Biological: Platelet Lysate

Interventions

Platelet LysateBIOLOGICAL

Eye drops of Platelet Lysate

Platelet Lysate

Eligibility Criteria

Age21 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Corneal ulcers which developed tissue scars.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cell Therapy Center

Amman, 11942, Jordan

Location

Related Publications (1)

  • 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.

    PMID: 29978342DERIVED

Study Officials

  • Abdallah Awidi, MD

    Cell Therapy Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 2, 2016

Study Start

February 16, 2017

Primary Completion

January 15, 2019

Study Completion

January 30, 2019

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations

JO(1)