Clinical trial NCT03298815: Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)
Official title: A Randomized, Double-Blinded, Placebo-Controlled Study for the Treatment of Ocular Chronic Graft-Versus-Host Disease (GVHD) With Amniotic Fluid Eye Drops (AFED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Ocular Graft Versus Host Disease
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: Overall Response Rate
timeFrame: 30 days
Secondary outcomes:
measure: Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 30 Days
timeFrame: baseline and 30 days
measure: Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 60 Days
timeFrame: baseline and 60 days
measure: Change in Functional Assessment of Cancer Therapy: General (FACT-G) From Baseline to 100 Days
timeFrame: baseline and 100 days
measure: Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 30 Days
timeFrame: baseline and 30 days
measure: Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 60 Days
timeFrame: baseline and 60 days
measure: Change in National Institutes of Health (NIH) Consensus Criteria (CC) Ocular Score of Chronic GVHD From Baseline to 100 Days
timeFrame: baseline and 100 days
measure: Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline to 30 Days
timeFrame: baseline and 30 days
measure: Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline and 60 Days
timeFrame: baseline and 60 days
measure: Change in Dry Eye Workshop (DEWS) 2007 Dry Eye Severity Grading From Baseline and 100 Days
timeFrame: baseline and 100 days
measure: Change in Pain Assessment From Baseline to 60 Days
timeFrame: baseline and 60 days
measure: Changes in Visual Acuity
timeFrame: baseline, 30 days, 60 days, and 100 days
measure: Effects on the Corneal Surface
timeFrame: Up to 100 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: University of Utah
name: Catherine J. Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: