Safety and Efficacy of Autologous PRP and PPP Eye Drops in the Treatment of Ocular GVHD
Withdrawn before enrolling · Phase 1
Conditions studied: Graft-versus-host Disease
In brief
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.
Key facts
- Study ID
- NCT02561520
- Run by
- Ladan Espandar
- People needed
- 0
- Starts
- 2016-12-01
- Expected to finish
- 2018-09-01
- Last updated by the study team
- 2017-08-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- UPMC Eye Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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