RecruitingPhase 1Phase 2NCT06852768

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

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)


Sponsor

Regenerative Ocular Immunobiologics LLC

Enrollment

1 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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 (oGHVD)


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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.

Exclusion Criteria17

  • 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.

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Interventions

BIOLOGICALd-MAPPS

Based on randomization d-MAPPS, will be self-administered, 2 drops into each eye four times a day (QID) a day for ninety (90) days.

BIOLOGICALPlacebo

Based on randomization, Placebo, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.

OTHERPI and Patient Masked

Both the PI and the participant are masked on the drug administered.


Locations(6)

Beverly Hills Institute of Ophthalmology

Beverly Hills, California, United States

Beach Eye Medical Group

Huntington Beach, California, United States

Regenerative Ocular Immunobiologics, LLC.

Palm Harbor, Florida, United States

Glenn Eye Center

Lexington, Kentucky, United States

Eyewell, LLC.

Boston, Massachusetts, United States

BostonSight

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT06852768