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NCT Number: NCT07776210

Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)

This is a Phase III, multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trial designed to evaluate the efficacy, safety, and tolerability of d-MAPPS™ Ophthalmic Solution in adult subjects with chronic ocular graft-versus-host disease (oGVHD). Eligible subjects will receive masked study treatment for 90 days, with the primary efficacy assessment performed at the Day 90 study visit.

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Key information

Conditions

oGVHD Ocular Graft Versus Host Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older.
  • Documented chronic ocular graft-versus-host disease (oGVHD) following allogeneic hematopoietic stem cell transplantation.
  • Investigator determines the participant is medically stable and appropriate for study participation.
  • Ocular Surface Disease Index (OSDI) Total Score of at least 33 at Baseline.
  • UNC Dry Eye Management Scale Visual Analog Scale (UNC DEMS VAS) score of at least 3 at Baseline.
  • Modified Oxford Corneal Staining Score of at least 1 in at least one eye.
  • Snellen Corrected Distance Visual Acuity sufficient to complete protocol-defined assessments.
  • Written informed consent obtained before study procedures.
  • Willing and able to comply with study visits, study treatment, and protocol requirements.
  • Background therapies stable for at least 30 days before Baseline.

Exclusion criteria

  • Acute ocular graft-versus-host disease or ocular disease that may interfere with efficacy assessment.
  • Active ocular or periocular infection, ocular malignancy, or active herpetic keratitis.
  • Intraocular surgery, refractive surgery, or ocular laser procedure within 6 weeks before Baseline or planned during the study.
  • Change in systemic immunosuppressive therapy, topical glaucoma therapy, or oral tetracycline therapy within 30 days before Baseline.
  • Initiation within 30 days before Baseline or during the trial of topical cyclosporine, lifitegrast, tacrolimus, autologous serum eye drops, platelet-rich plasma eye drops, amniotic membrane products, or another prescription therapy intended to treat ocular surface disease.
  • Participation in another investigational study within 30 days before Screening or concurrent enrollment.
  • Pregnancy or breastfeeding.

Treatment and study plan

d-MAPPS™ Ophthalmic Solution

Biological

Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.

Matching vehicle control

Biological

Matching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days.

Primary outcomes

  1. Change From Baseline to Day 90 in Modified Oxford Corneal Staining Score

    Time frame: Baseline to Day 90 (±5 days)

    Corneal fluorescein staining will be assessed in the prespecified study eye using the Modified Oxford grading scale. Scores range from 0 to 5, where 0 represents no corneal staining and higher scores represent progressively greater staining. A decrease from Baseline indicates improvement.

  2. Change From Baseline to Day 90 in Ocular Surface Disease Index (OSDI) Total Score

    Time frame: Baseline to Day 90 (±5 days)

    The Ocular Surface Disease Index (OSDI) will assess ocular symptoms and their effect on vision-related functioning. Total scores range from 0 to 100, with higher scores representing greater symptom burden. A decrease from Baseline indicates improvement.

Secondary outcomes

  1. Percentage of Participants With a ≥1-Grade Decrease in Modified Oxford Corneal Staining Score

    Time frame: Baseline to Day 90 (±5 days)

    The proportion of participants achieving at least a 1-grade decrease from Baseline to Day 90 in the prespecified study eye. Scores range from 0 to 5, with higher scores indicating greater corneal staining. A decrease indicates improvement.

  2. Change From Baseline to Day 90 in Supportive Efficacy Measures in the Fellow Eye

    Time frame: Baseline to Day 90 (±5 days)

    Change from Baseline to Day 90 in protocol-defined eye-specific efficacy measures collected in the fellow eye. Fellow-eye data will be analyzed separately and will not be pooled with or substituted for data from the prespecified study eye.

  3. Percentage of Participants With Modified Oxford Corneal Staining Score Grade 0 at Day 90

    Time frame: Day 90 (±5 days)

    The proportion of participants achieving complete resolution of corneal staining, defined as Modified Oxford Corneal Staining Score Grade 0 in the prespecified study eye at Day 90.

  4. Change From Baseline to Day 90 in Superficial Punctate Keratitis (SPK) Severity

    Time frame: Baseline to Day 90 (±5 days)

    Change from Baseline to Day 90 in SPK severity in the prespecified study eye. A decrease in severity indicates improvement.

  5. Percentage of Participants With a ≥1-Grade Decrease in Superficial Punctate Keratitis (SPK) Severity

    Time frame: Baseline to Day 90 (±5 days)

    The proportion of participants achieving at least a 1-grade decrease from Baseline to Day 90 in SPK severity in the prespecified study eye. A decrease indicates improvement.

  6. Percentage of Participants With Superficial Punctate Keratitis (SPK) Severity of 0 at Day 90

    Time frame: Day 90 (±5 days)

    The proportion of participants achieving complete resolution of SPK, defined as an SPK severity score of 0 in the prespecified study eye at Day 90.

  7. Percentage of Participants With a ≥13-Point Decrease in OSDI Total Score

    Time frame: Baseline to Day 90 (±5 days)

    The proportion of participants achieving a decrease of at least 13 points from Baseline to Day 90 in Ocular Surface Disease Index (OSDI) Total Score. Scores range from 0 to 100, with higher scores indicating greater symptom burden. A decrease indicates improvement.

  8. Change From Baseline to Day 90 in NIH Eye Score

    Time frame: Baseline to Day 90 (±5 days)

    Change from Baseline to Day 90 in the NIH Eye Score. A decrease in score indicates improvement in ocular graft-versus-host disease severity.

  9. Percentage of Participants With a ≥1-Grade Decrease in NIH Eye Score

    Time frame: Baseline to Day 90 (±5 days)

    The proportion of participants achieving at least a 1-grade decrease from Baseline to Day 90 in the NIH Eye Score. A decrease indicates improvement in ocular graft-versus-host disease severity.

  10. Percentage of Participants With No Worsening in NIH Eye Score at Day 90

    Time frame: Baseline to Day 90 (±5 days)

    The proportion of participants whose NIH Eye Score at Day 90 is equal to or lower than their Baseline score. A lower score indicates improvement, while an unchanged score indicates no worsening.

  11. Change From Baseline to Day 90 in UNC Dry Eye Management Scale Visual Analog Scale Score

    Time frame: Baseline to Day 90 (±5 days)

    Change from Baseline to Day 90 in the UNC Dry Eye Management Scale (UNC DEMS) Visual Analog Scale score. A decrease indicates improvement in dry-eye symptom burden.

  12. Change From Baseline to Day 90 in Tear Break-Up Time (TBUT)

    Time frame: Baseline to Day 90 (±5 days)

    Change from Baseline to Day 90 in tear break-up time, measured in seconds, in the prespecified study eye. An increase indicates improvement in tear-film stability.

  13. Percentage of Participants Receiving Protocol-Defined Rescue Therapy

    Time frame: Randomization through Day 90

    The proportion of participants receiving at least one administration of protocol-defined rescue therapy during the randomized treatment period.

  14. Time to First Administration of Protocol-Defined Rescue Therapy

    Time frame: Randomization through Day 90

    Time from randomization to the first administration of protocol-defined rescue therapy.

  15. Percentage of Participants With Protocol-Defined Treatment Failure

    Time frame: Randomization through Day 90

    The proportion of participants experiencing treatment failure, defined as initiation of protocol-defined rescue therapy, permanent discontinuation of assigned study treatment because it is not providing adequate benefit, or withdrawal from all further study participation because of worsening ocular GVHD signs or symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Marissa Harrell, PhD

CONTACT

[email protected]

727-748-0420

Sponsors and collaborators

Lead sponsor

Regenerative Ocular Immunobiologics LLC

Industry

Registry information

Official study title

A Randomized, Double-Masked, Vehicle-Controlled, Adequate and Well-Controlled Pivotal Study With Co-Primary Endpoints to Evaluate the Safety and Efficacy of d-MAPPS™ Ophthalmic Solution in Subjects With Chronic Ocular Graft-Versus-Host Disease (oGVHD)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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