Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)

  • STATUS
    Recruiting
  • End date
    Nov 11, 2024
  • participants needed
    15
  • sponsor
    University of Utah
Updated on 11 February 2021

Summary

A Randomized, Double-blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft Verses Host Disease with Processed Amniotic Fluid (pAF) Drops.

Description

This is a randomized (to each eye, within patient), double-blinded, placebo-controlled study of the efficacy of Processed Amniotic Fluid (pAF) in patients with hematologic malignancies who have undergone Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and are diagnosed with Chronic Graft Verses Host Disease of the eye.

Details
Condition Ocular Graft Versus Host Disease
Treatment Saline solution, Amniotic Fluid Eye Drops (AFED)
Clinical Study IdentifierNCT03298815
SponsorUniversity of Utah
Last Modified on11 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients diagnosed within 3 years after hematopoietic stem cell transplant for any disease, with any graft and any conditioning regimen with at least one of the
following
Dry eye symptoms partially affecting (requiring lubricant drops > 3 x per day or punctal plugs) or significantly affecting (special eyeware to relieve pain) activities of daily living (ADL)
Unable to work because of ocular symptoms
Loss of vision due to keratoconjunctivitis sicca (KCS)
Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual
Patients who are 18 years of age or older
Willing and able to provide informed consent

Exclusion Criteria

Patients who have any other reversible cause for dry eye at the time of accrual
More than 2 lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimus
Relapsed malignancy after transplantation
A difference in dryness between both eyes of more than 2 points of the grading provided by the International Dry Eye Workshop (DEWS) 2007 report
Patients who are pregnant or plan to become pregnant while participating in the study
Patients who are not willing to discontinue the use of any eye drops, with the exception of non-medicated lubricant eye drops (artificial tears). All eye drops (excluding non-medicated lubricant eye drops) must be stopped at least seven days before treatment with pAF
Inability to comply with the investigational plan and visit schedule for any
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