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Study did not enroll participants is being withdrawn from the system.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP and PPP | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP eye drops | Biological | Eye drops 4x a day, patients will start this eye drop first. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Efficacy of topical autologous PRP and PPP as measured by Tear Film Break Up Time (TBUT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ladan Espandar, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Eye Center | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| PPP eye drops | Biological | Eye drops 4x a day, patients will start this eye drops after PRP. |
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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. |
| 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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. | 8 weeks |
| 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 | 8 weeks |
| 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) | 8 weeks |