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

May 27, 2026 updated by: Regenerative Ocular Immunobiologics LLC

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)

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • Beverly Hills Institute of Ophthalmology
      • Huntington Beach, California, United States, 92648
        • Beach Eye Medical Group
    • Florida
      • Palm Harbor, Florida, United States, 34684
        • Regenerative Ocular Immunobiologics, LLC.
    • Kentucky
      • Lexington, Kentucky, United States, 40511
        • Glenn Eye Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Eyewell, LLC.
      • Boston, Massachusetts, United States, 02494
        • BostonSight

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: This arm randomizes the actual drug to the patient.
Based on randomization, d-MAPPS™ will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
Biological: d-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.
Placebo Comparator: This arm randomizes the placebo to the patient.
Based on randomization Placebo/sterile water, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
Biological: Placebo
Based on randomization, Placebo, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
Other: Both patient and PI are masked.
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.
Biological: Placebo
Based on randomization, Placebo, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
Other: PI and Patient Masked
Both the PI and the participant are masked on the drug administered.
Biological: d-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from Baseline utilizing University of North Carolina Dry Eye Management Scale (UNC DEMS) Scores
Time Frame: Through study completion, an average of 4 months.
The UNC Dry Eye Management Scale (DEMS) helps evaluate different aspects of DED, including symptoms, severity, and impact on daily life. Dry eye symptoms such as grittiness, dryness, foreign body sensation, redness, tearing, and irritation. The UNC DEMS is used in clinical settings to inform treatment decisions and monitor the effectiveness of interventions. UNC DEMS scores are on a scale from 1-10, with 10 being the most severe. The changes will be evaluated from baseline and at timepoints 30 ±5 days, 60 ±5 days and 90 ±5 days.
Through study completion, an average of 4 months.
Changes from Baseline utilizing Ocular Surface Disease Index (OSDI)
Time Frame: Through study completion, an average of 4 months.
Ocular Surface Disease Index (OSDI) Questionnaire is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate each of the dry eye symptoms on a 0-4 scale. The results are calculated in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. The changes will be evaluated from baseline and at timepoints 30 ±5 days, 60 ±5 days and 90 ±5 days.
Through study completion, an average of 4 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline utilizing the NIH Eye Score for chronic oGVHD
Time Frame: Through study completion, an average of 4 months.
The NIH Eye Score is a recommended measure, as it detects improvement or worsening in ocular chronic GVHD. Scoring from 0 to 3 is based on symptoms, need for eye drops, and use of therapeutic procedures or devices.
Through study completion, an average of 4 months.
Changes from Baseline Oxford Schema for Corneal and Conjunctival Stain Grades
Time Frame: Through study completion, an average of 4 months.
Oxford Schema for Corneal and Conjunctival Staining is a diagnostic test that looks for signs of damage or dryness in the eye. It involves a doctor applying dye to the eye to show areas of damage on its surface. The Oxford grading scale divides corneal staining into 6 groups according to severity: 0 = absent, I = minimal, II = mild, III = moderate, IV = marked, and V = severe. The changes will be evaluated from baseline and at timepoints 30 ±5 days, 60 ±5 days and 90±5 days.
Through study completion, an average of 4 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regenerative Ocular Immunobiologics LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30066

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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