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

University of Utah15 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ocular Graft Versus Host Disease

Interventions

Amniotic Fluid Eye Drops (AFED)BIOLOGICAL

One drop (0.25 mL) in one eye twice daily for up to 3 months

Saline SolutionOTHER

One drop (0.25 mL) in the other eye twice daily for up to 3 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Overall Response Rate

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.

Time frame: 30 days

Secondary Outcomes

Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 30 Days

Change in Quality of Life questionnaire from baseline to 30 days. FACT-G is a combination score of physical, social/family, emotional, and functional well-being. The score ranges from 0 to 108. The higher the score, the better the quality of life.

Time frame: baseline and 30 days

Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 60 Days

Change in Quality of Life questionnaire from baseline to 60 days. FACT-G is a combination score of physical, social/family, emotional, and functional well-being. The score ranges from 0 to 108. The higher the score, the better the quality of life.

Time frame: baseline and 60 days

Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 100 Days

Change in Quality of Life questionnaire from baseline to 100 days. FACT-G is a combination score of physical, social/family, emotional, and functional well-being. The score ranges from 0 to 108. The higher the score, the better the quality of life.

Time frame: baseline and 100 days

Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 30 Days

Change in ocular score using a four-point scale from 0 (no dry eye symptoms) to 3 (severe dry eye symptoms) from baseline to 30 days.

Data from ClinicalTrials.gov

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