NCT03298815

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ocular Graft Versus Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Amniotic Fluid Eye Drops (AFED)	One drop (0.25 mL) in one eye twice daily for up to 3 months
OTHER	Saline Solution	One drop (0.25 mL) in the other eye twice daily for up to 3 months

Timeline

• Start date: 2019-12-20
• Primary completion: 2022-12-16
• Completion: 2023-02-24
• First posted: 2017-10-02
• Last updated: 2025-04-09
• Results posted: 2025-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study