Clinical trial NCT02561520: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Graft-versus-host Disease
Keywords: platelet rich plasma
platelet poor plasma
ocular GVHD
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: 8 Weeks
Secondary outcomes:
measure: Efficacy of topical autologous PRP and PPP as measured by the National Eye Institute (NEI) grading scale
timeFrame: 8 weeks
measure: Efficacy of topical autologous PRP and PPP as measured by Tear Film Break Up Time (TBUT)
timeFrame: 8 weeks
measure: Efficacy of topical autologous PRP and PPP as measured by Schirmer Test I
timeFrame: 8 weeks
measure: Efficacy of topical autologous PRP and PPP as measured by expression of cellular markers of inflammation using real-time polymerase chain reaction (RT-PCR)
timeFrame: 8 weeks
measure: Efficacy of topical autologous PRP and PPP as measured by expression of cellular markers of inflammation using flow cytometry (FC)
timeFrame: 8 weeks
measure: Efficacy of topical autologous PRP and PPP as measured by Ocular Surface Disease Index (OSDI) questionnaire
timeFrame: 8 weeks
measure: Efficacy of topical autologous PRP and PPP as measured by National Eye Institute-Visual Function Questionnaire (NEI-VFQ-25)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Eye Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ladan Espandar, MD
role: PRINCIPAL_INVESTIGATOR
References: