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

Last updated: April 7, 2025
Sponsor: Regenerative Ocular Immunobiologics LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

d-Mapps

Placebo

PI and Patient Masked

Clinical Study ID

NCT06852768
30066
  • Ages > 18
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

Inclusion 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 thestudy.

  • Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at thetime 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

Exclusion Criteria:

  • History of Rheumatoid Arthritis, Lupus, Scleroderma.

  • Ocular or periocular malignancy.

  • Significant change, as judged by the principal investigator, in systemicimmunosuppressive regimen within 2 weeks of study entry.

  • Any history of topical tacrolimus use.

  • Any change in dosage of tetracycline compounds (tetracycline, doxycycline, andminocycline) within the last month.

  • Any change in frequency of preserved anti-glaucoma medications within 2 weeks ofstudy 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 whileparticipating in the study. If of childbearing potential, unwillingness to useeffective birth control while participating in the study.

  • Any condition (including language barrier) that precludes patient's ability tocomply with study requirements including completion of study.

Study Design

Total Participants: 1
Treatment Group(s): 3
Primary Treatment: d-Mapps
Phase: 1/2
Study Start date:
January 10, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Beach Eye Medical Group

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • Regenerative Ocular Immunobiologics, LLC.

    Palm Harbor, Florida 34684
    United States

    Active - Recruiting

  • Kentucky Eye Institute

    Lexington, Kentucky 40517
    United States

    Active - Recruiting

  • Eyewell, LLC.

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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