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

Utah System of Higher Education (USHE)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Ocular Graft Versus Host Disease

Treatments

Biological: Amniotic Fluid Eye Drops (AFED)

Other: Saline Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT03298815

103515

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed within 5 years after hematopoietic stem cell transplant for any disease, with any graft and any conditioning regimen with at least one of the following symptoms:
1. Dry eye symptoms partially affecting (requiring lubricant drops > 3 x per day or punctal plugs, or thermally cauterized puncta) or significantly affecting (special eyeware to relieve pain) activities of daily living (ADL)
2. Unable to work because of ocular symptoms
3. 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 3 lines of therapy beyond corticosteroids with or without calcineurin inhibitors or sirolimus
Relapsed malignancy at time of accrual after the most recent 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 reason, in the judgement of the investigator.