NCT02561520

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

Safety and Efficacy of Autologous Platelet Rich Plasma and Platelet Poor Plasma Eye Drops in the Treatment of Ocular Graft-Versus-Host Disease

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ladan Espandar · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft-versus-host Disease

Interventions

Type	Name	Description
BIOLOGICAL	PRP eye drops	Eye drops 4x a day, patients will start this eye drop first.
BIOLOGICAL	PPP eye drops	Eye drops 4x a day, patients will start this eye drops after PRP.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2015-09-28
• Last updated: 2017-08-28

Locations

1 site across 1 country: United States