A Randomized, Double-Blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)

University of Utah1 site in 1 country15 target enrollmentDecember 20, 2019

ConditionsOcular Graft Versus Host Disease

InterventionsAmniotic Fluid Eye Drops (AFED)Saline Solution

Overview

Phase: Phase 1
Intervention: Amniotic Fluid Eye Drops (AFED)
Conditions: Ocular Graft Versus Host Disease
Sponsor: University of Utah
Enrollment: 15
Locations: 1
Primary Endpoint: Overall Response Rate
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

December 20, 2019

End Date

February 24, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Utah

Responsible Party

Principal Investigator

Catherine Lee

University of Utah

Eligibility Criteria

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:
•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)
•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 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.

Arms & Interventions

Amniotic Fluid Eye Drops (AFED) - All participants, One eye

Intervention: Amniotic Fluid Eye Drops (AFED)

Saline Solution - All participants, One eye

Intervention: Saline Solution

Outcomes

Primary Outcomes

Overall Response Rate

Time Frame: 30 days

Response is a composite of the NIH Consensus Conference (CC) for assessment of response in chronic GVHD (eye score) and the International Dry Eye Workshop (DEWS) grading scale. Responders would be defined as a one point improvement in the dry eye grading scale (DEWS), without worsening in the eye score.

Secondary Outcomes

Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 100 Days(baseline and 100 days)
Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 30 Days(baseline and 30 days)
Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 60 Days(baseline and 60 days)
Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 100 Days(baseline and 100 days)
Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline to 30 Days(baseline and 30 days)
Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline and 60 Days(baseline and 60 days)
Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline and 100 Days(baseline and 100 days)
Change in Pain Assessment From Baseline to 60 Days(baseline and 60 days)
Changes in Visual Acuity(baseline, 30 days, 60 days, and 100 days)
Effects on the Corneal Surface(Up to 100 days)
Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 30 Days(baseline and 30 days)
Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 60 Days(baseline and 60 days)