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

Regenerative Ocular Immunobiologics LLC

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: oGHVD

Treatments: Biological: d-MAPPS; Other: PI and Patient Masked; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06852768

30066

Details and patient eligibility

About

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)

Enrollment: 1 estimated patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1 participants in 3 patient groups, including a placebo group

This arm randomizes the actual drug to the patient.

Active Comparator group

Description:

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

Treatment:

Biological: d-MAPPS

This arm randomizes the placebo to the patient.

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo

Both patient and PI are masked.

Other group

Description:

Upon acceptance into the study, the sponsor will be notified, and the patient will be randomized to the treatment or placebo arm. Randomization Code Key will have limited access to only authorized personnel. Based on the results of the randomization selection, the sponsor will provide the appropriate subject number and lot coded eyedropper bottles containing d-MAPPS™ or Placebo/sterile water to the doctor for dissemination.

Treatment:

Biological: Placebo

Other: PI and Patient Masked

Biological: d-MAPPS