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

NCT06852768 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 30066
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 6

Brief 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)

Conditions

oGHVD

Outcome Measures

Primary Outcomes (2)

• Changes from Baseline utilizing University of North Carolina Dry Eye Management Scale (UNC DEMS) Scores

  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)

  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 Outcomes (2)

• Changes from baseline utilizing the NIH Eye Score for chronic oGVHD

  Through study completion, an average of 4 months.

• Changes from Baseline Oxford Schema for Corneal and Conjunctival Stain Grades

  Through study completion, an average of 4 months.

Study Arms (3)

This arm randomizes the actual drug to the patient.

ACTIVE COMPARATOR

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

This arm randomizes the placebo to the patient.

PLACEBO COMPARATOR

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

Both patient and PI are masked.

OTHER

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

Interventions

PI and Patient Masked OTHER

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

Both patient and PI are masked.

d-MAPPS BIOLOGICAL

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.

Both patient and PI are masked.; This arm randomizes the actual drug to the patient.

Placebo BIOLOGICAL

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

Both patient and PI are masked.; This arm randomizes the placebo to the patient.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Regenerative Ocular Immunobiologics LLC: lead

Study Sites (6)

Beverly Hills Institute of Ophthalmology

Beverly Hills, California, 90210, United States

RECRUITING

Beach Eye Medical Group

Huntington Beach, California, 92648, United States

RECRUITING

Regenerative Ocular Immunobiologics, LLC.

Palm Harbor, Florida, 34684, United States

RECRUITING

Glenn Eye Center

Lexington, Kentucky, 40511, United States

RECRUITING

Eyewell, LLC.

Boston, Massachusetts, 02215, United States

RECRUITING

BostonSight

Boston, Massachusetts, 02494, United States

RECRUITING

Central Study Contacts

Marissa Harrell, Phd

CONTACT

727-748-0420; info@roiglobalsolutions.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 28, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (6)