Safety and Efficacy of Autologous PRP and PPP Eye Drops in the Treatment of Ocular GVHD

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.

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.