D-MAPPS for Graft-versus-Host Disease
(oGVHD Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Regenerative Ocular Immunobiologics LLC

Trial Summary

What is the purpose of this trial?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

This trial is for individuals with chronic ocular Graft-Versus-Host Disease (oGVHD), a condition affecting the eyes after stem cell or bone marrow transplantation. Participants should not have high blood pressure to be eligible.

Inclusion Criteria

Minimum Oxford Schema grad of ≥ 1 in at least one eye

I am 18 years old or older.

Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual

+5 more

Exclusion Criteria

Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry

I have a cancer affecting my eye or nearby areas.

I haven't changed my tetracycline medication dose in the last month.

+12 more

Participant Groups

The study tests D-MAPPS™ Ophthalmic Solution against a placebo to evaluate its safety, tolerability, and effectiveness in treating oGVHD. It's a double-masked trial, meaning neither the participants nor the investigators know who receives the real treatment or placebo.

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Both patient and PI are masked.Experimental Treatment3 Interventions

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.

Group II: This arm randomizes the actual drug to the patient.Active Control1 Intervention

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

Group III: This arm randomizes the placebo to the patient.Placebo Group1 Intervention

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