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

NCT ID: NCT02561520

Last Updated: 2017-08-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-09-30

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.

Conditions

Graft-versus-host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRP and PPP

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.

Group Type: EXPERIMENTAL

PRP eye drops

Intervention Type: BIOLOGICAL

Eye drops 4x a day, patients will start this eye drop first.

PPP eye drops

Intervention Type: BIOLOGICAL

Eye drops 4x a day, patients will start this eye drops after PRP.

Interventions

PRP eye drops

Eye drops 4x a day, patients will start this eye drop first.

Intervention Type: BIOLOGICAL

PPP eye drops

Eye drops 4x a day, patients will start this eye drops after PRP.

Intervention Type: BIOLOGICAL

Other Intervention Names

Platelet rich plasma; Platelet poor plasma

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ladan Espandar

OTHER

Sponsor Role: lead

Responsible Party

Ladan Espandar

Assisant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ladan Espandar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Eye Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO15070211

Identifier Type: -

Identifier Source: org_study_id