Study of D-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)

Description

A Double-Masked, Randomized, Placebo-Controlled Study of the Safety and Tolerability and Efficacy of d-Mapps™ Opthalmic Solution in the Treatment of Chronic Oscular Graft-Versus-Host Disease (oGHVD)

Conditions

OGHVD

Study Overview

Study Details

Study overview

A Double-Masked, Randomized, Placebo-Controlled Study of the Safety and Tolerability and Efficacy of d-Mapps™ Opthalmic Solution in the Treatment of Chronic Oscular Graft-Versus-Host Disease (oGHVD)

A Double-Masked, Randomized, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of D-MAPPS™ Ophthalmic Solution in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)

Study of D-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)

Condition
OGHVD
Intervention / Treatment

-

Contacts and Locations

Palm Harbor

Regenerative Ocular Immunobiologics, LLC., Palm Harbor, Florida, United States, 34684

Lexington

Kentucky Eye Institute, Lexington, Kentucky, United States, 40517

Boston

Eyewell, LLC., Boston, Massachusetts, United States, 02215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years.
  • * Willing and able to provide written informed consent.
  • * Willing and able to comply with study assessments for the full duration of the study.
  • * Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
  • * Minimum Oxford Schema grad of ≥ 1 in at least one eye.
  • * OSDI scored of ≥ 22.
  • * UNC DEMS score of ≥ 3.
  • * In good stable overall health.
  • * History of Rheumatoid Arthritis, Lupus, Scleroderma.
  • * Ocular or periocular malignancy.
  • * Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.
  • * Any history of topical tacrolimus use.
  • * Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
  • * Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry.
  • * Current use of topical steroids more than twice a day.
  • * Corneal epithelial defect \> 1mm2.
  • * Any history of herpetic keratitis.
  • * Participation in another simultaneous medical research study.
  • * Signs of current infection, including fever and current treatment with antibiotics.
  • * All vaccination including COVID are prohibited during this study.
  • * Signs of current infection, including fever and current treatment with antibiotics.
  • * All vaccinations including COVID are prohibited during this study.
  • * Intra-ocular surgery or ocular laser surgery within 3 months.
  • * Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of childbearing potential, unwillingness to use effective birth control while participating in the study.
  • * Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Regenerative Ocular Immunobiologics LLC,

Study Record Dates

2025-12