Back to resultsSafety and Efficacy of Autologous PRP and PPP Eye Drops in the Treatment of Ocular GVHD
Primary Purpose
Graft-versus-host Disease
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PRP eye drops
PPP eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Graft-versus-host Disease focused on measuring platelet rich plasma, platelet poor plasma, ocular GVHD
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years.
- Willing and able to provide written informed consent.
- Willing and able to comply with study assessments for the full duration of the study.
- Diagnosis of ocular GVHD.
- Minimum corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye.
- In good stable overall health.
Exclusion Criteria:
- Remission from primary cancer in more than 5 years.
- History of thrombocytopenia (platelet<50,000) in the last 2 weeks before study entry.
- Ocular or periocular malignancy.
- Significant change, as judged by the PI, in systemic immunosuppressive regimen before 2 weeks of study entry.
- Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
- Any change in frequency of preserved anti-glaucoma medications before 2 weeks of study entry.
- Current use of topical steroids more than twice a day.
- Change in frequency of topical cyclosporine and/or topical kineret within the last month.
- Signs of current infection, including fever and current treatment with antibiotics.
- Intra-ocular surgery or ocular laser surgery within the last 3 months.
- Has worn contact lenses, except for bandage contact lens or rigid gas permeable lens or scleral contact lens, for the last 2 weeks prior to the study or would be unable to stay off contact lenses for the study duration.
- Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
Sites / Locations
- UPMC Eye Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRP and PPP
Arm Description
PRP eye drops and PPP eye drops will be prepared from patient's own blood by Magellan technology. Patients will receive eye drops in sterile amber glass droppers. Patients will be instructed to keep refrigerated each bottle after opening for 7 days and keep frozen the unopened bottles up to 30 days.
Outcomes
Primary Outcome Measures
Number of Participants With Treatment-Related Adverse Events
Safety and tolerability of topical autologous PRP and PPP four times a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the autologous blood products. The severity of each adverse event and relation to the study medication will be graded possibly, probably, or definitely related. Tolerability measures will be graded from trace to severe using a direct query method at each visit.
Secondary Outcome Measures
Efficacy of topical autologous PRP and PPP as measured by the National Eye Institute (NEI) grading scale
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing signs of dry eye in ocular GVHD, cornea fluorescein staining will be used using NEI grading system.
Efficacy of topical autologous PRP and PPP as measured by Tear Film Break Up Time (TBUT)
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing signs of dry eye in ocular GVHD,Tear Film Break Up Time (TBUT) will be used.
Efficacy of topical autologous PRP and PPP as measured by Schirmer Test I
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing signs of dry eye in ocular GVHD, Schirmer test without topical anesthetic will be used.
Efficacy of topical autologous PRP and PPP as measured by expression of cellular markers of inflammation using real-time polymerase chain reaction (RT-PCR)
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing signs of dry eye in ocular GVHD, expression of cellular markers of inflammation such as (intercellular adhesion molecule-1 (ICAM-1), interleukin IL-1b, IL-2, IL-6, IL-8, IL-10, IL-17, IL-23, interferon IFN-g and tumor necrosis factor TNF-α) will be used using real-time polymerase chain reaction (RT-PCR) on schirmer filter papers.
Efficacy of topical autologous PRP and PPP as measured by expression of cellular markers of inflammation using flow cytometry (FC)
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing signs of dry eye in ocular GVHD, expression of cellular markers of inflammation such as (intercellular adhesion molecule-1 (ICAM-1), interleukin IL-1b, IL-2, IL-6, IL-8, IL-10, IL-17, IL-23, interferon IFN-g and tumor necrosis factor TNF-α) will be used using flow cytometry (FC) on schirmer filter papers.
Efficacy of topical autologous PRP and PPP as measured by Ocular Surface Disease Index (OSDI) questionnaire
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing symptoms of dry eye in ocular GVHD by Surface Disease Index (OSDI) questionnaire
Efficacy of topical autologous PRP and PPP as measured by National Eye Institute-Visual Function Questionnaire (NEI-VFQ-25)
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing symptoms of dry eye in ocular GVHD by National Eye Institute-Visual Function Questionnaire (NEI-VFQ-25)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02561520
Brief Title
Safety and Efficacy of Autologous PRP and PPP Eye Drops in the Treatment of Ocular GVHD
Official Title
Safety and Efficacy of Autologous Platelet Rich Plasma and Platelet Poor Plasma Eye Drops in the Treatment of Ocular Graft-Versus-Host Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study did not enroll participants is being withdrawn from the system.
Study Start Date
December 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ladan Espandar
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of autologous Platelet Rich Plasma (PRP) and Platelet Poor Plasma (PPP) eye drops four times a day in the treatment of ocular graft versus host disease (O-GVHD). In addition to their current medication (except autologous serum drops), patients will receive PRP and PPP drops.
Detailed Description
Ocular involvement can be quite symptomatic in patients with chronic graft-versus-host disease (GVHD). The impact of ocular GVHD on quality of life (QOL) in patients with chronic GVHD has been studied in a prospective, multicenter, longitudinal, observational study and showed that ocular GVHD affects 57% of patients within 2 years of chronic GVHD diagnosis. Strong evidence suggested that ocular GVHD is associated with worse overall health-related QOL. Significant worsening of vision-related QOL in ocular GVHD has been reported. Ocular GVHD is devastating and there is no effective treatment available so far. The importance of this study is that for the first time in the nation, our institute will evaluate the safety and efficacy of topical autologous blood product (PRP and PPP) to treat ocular surface disease associated with ocular GVHD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft-versus-host Disease
Keywords
platelet rich plasma, platelet poor plasma, ocular GVHD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRP and PPP
Arm Type
Experimental
Arm Description
PRP eye drops and PPP eye drops will be prepared from patient's own blood by Magellan technology. Patients will receive eye drops in sterile amber glass droppers. Patients will be instructed to keep refrigerated each bottle after opening for 7 days and keep frozen the unopened bottles up to 30 days.
Intervention Type
Biological
Intervention Name(s)
PRP eye drops
Other Intervention Name(s)
Platelet rich plasma
Intervention Description
Eye drops 4x a day, patients will start this eye drop first.
Intervention Type
Biological
Intervention Name(s)
PPP eye drops
Other Intervention Name(s)
Platelet poor plasma
Intervention Description
Eye drops 4x a day, patients will start this eye drops after PRP.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Related Adverse Events
Description
Safety and tolerability of topical autologous PRP and PPP four times a day will be monitored by the occurrence of systemic and ocular adverse events in addition to symptoms directly related to the instillation or use of the autologous blood products. The severity of each adverse event and relation to the study medication will be graded possibly, probably, or definitely related. Tolerability measures will be graded from trace to severe using a direct query method at each visit.
Time Frame
8 Weeks
Secondary Outcome Measure Information:
Title
Efficacy of topical autologous PRP and PPP as measured by the National Eye Institute (NEI) grading scale
Description
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing signs of dry eye in ocular GVHD, cornea fluorescein staining will be used using NEI grading system.
Time Frame
8 weeks
Title
Efficacy of topical autologous PRP and PPP as measured by Tear Film Break Up Time (TBUT)
Description
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing signs of dry eye in ocular GVHD,Tear Film Break Up Time (TBUT) will be used.
Time Frame
8 weeks
Title
Efficacy of topical autologous PRP and PPP as measured by Schirmer Test I
Description
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing signs of dry eye in ocular GVHD, Schirmer test without topical anesthetic will be used.
Time Frame
8 weeks
Title
Efficacy of topical autologous PRP and PPP as measured by expression of cellular markers of inflammation using real-time polymerase chain reaction (RT-PCR)
Description
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing signs of dry eye in ocular GVHD, expression of cellular markers of inflammation such as (intercellular adhesion molecule-1 (ICAM-1), interleukin IL-1b, IL-2, IL-6, IL-8, IL-10, IL-17, IL-23, interferon IFN-g and tumor necrosis factor TNF-α) will be used using real-time polymerase chain reaction (RT-PCR) on schirmer filter papers.
Time Frame
8 weeks
Title
Efficacy of topical autologous PRP and PPP as measured by expression of cellular markers of inflammation using flow cytometry (FC)
Description
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing signs of dry eye in ocular GVHD, expression of cellular markers of inflammation such as (intercellular adhesion molecule-1 (ICAM-1), interleukin IL-1b, IL-2, IL-6, IL-8, IL-10, IL-17, IL-23, interferon IFN-g and tumor necrosis factor TNF-α) will be used using flow cytometry (FC) on schirmer filter papers.
Time Frame
8 weeks
Title
Efficacy of topical autologous PRP and PPP as measured by Ocular Surface Disease Index (OSDI) questionnaire
Description
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing symptoms of dry eye in ocular GVHD by Surface Disease Index (OSDI) questionnaire
Time Frame
8 weeks
Title
Efficacy of topical autologous PRP and PPP as measured by National Eye Institute-Visual Function Questionnaire (NEI-VFQ-25)
Description
To evaluate the efficacy of topical autologous PRP and PPP four times a day in reducing symptoms of dry eye in ocular GVHD by National Eye Institute-Visual Function Questionnaire (NEI-VFQ-25)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years.
Willing and able to provide written informed consent.
Willing and able to comply with study assessments for the full duration of the study.
Diagnosis of ocular GVHD.
Minimum corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye.
In good stable overall health.
Exclusion Criteria:
Remission from primary cancer in more than 5 years.
History of thrombocytopenia (platelet<50,000) in the last 2 weeks before study entry.
Ocular or periocular malignancy.
Significant change, as judged by the PI, in systemic immunosuppressive regimen before 2 weeks of study entry.
Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
Any change in frequency of preserved anti-glaucoma medications before 2 weeks of study entry.
Current use of topical steroids more than twice a day.
Change in frequency of topical cyclosporine and/or topical kineret within the last month.
Signs of current infection, including fever and current treatment with antibiotics.
Intra-ocular surgery or ocular laser surgery within the last 3 months.
Has worn contact lenses, except for bandage contact lens or rigid gas permeable lens or scleral contact lens, for the last 2 weeks prior to the study or would be unable to stay off contact lenses for the study duration.
Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ladan Espandar, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Efficacy of Autologous PRP and PPP Eye Drops in the Treatment of Ocular GVHD
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