d-MAPPS Ophthalmic Solution for adults with chronic oGVHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-masked, vehicle-controlled Phase III study evaluating the efficacy, safety, and tolerability of d-MAPPS Ophthalmic Solution in adults with chronic ocular GVHD after allogeneic stem cell transplant. Participants will receive either the active eye drops or a matching vehicle for 90 days, with the main efficacy assessment at Day 90. Key eligibility requires documented chronic oGVHD, stable background therapy, and specific ocular surface disease measures at baseline. Primary outcomes will focus on improvements in ocular surface disease indicators and patient-reported symptoms. Safety and tolerability will be monitored throughout the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beverly Hills Institute of Ophthalmology
  Beverly Hills, California, United States Recruiting
• Beverly Hills Optometry
  Beverly Hills, California, United States Recruiting
• Eyewell, LLC.
  Boston, Massachusetts, United States Recruiting
• BostonSight
  Boston, Massachusetts, United States Recruiting
• Regenerative Ocular Immunobiologics, LLC.
  Palm Harbor, Florida, United States Not yet recruiting

Study contacts

• Study coordinator: Marissa Harrell, PhD
• Email: info@roiglobalsolutions.org
• Phone: 727-748-0420

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Phase II randomized double-masked crossover test of rhPRG4 (450 µg/mL) eye drops versus vehicle for ocular GVHD dry eye

  This 84-day crossover study will try rhPRG4 eye drops versus a vehicle drop in adults with moderate to severe ocular graft‑versus‑host disease to see if eye symptoms and corneal staining get better.

  Recruiting at 2 sites Phase 2 Lubris Bio Pty Ltd · Sydney, New South Wales and 2 other locations · NCT07118254

• Identifying treatment targets and biomarkers for dry eye disease in cancer patients

  This study is trying to learn more about eye problems in cancer patients, especially those with a specific condition, by looking at their eyes over time and comparing them to healthy individuals.

  Recruiting University of Maryland, Baltimore · Baltimore, Maryland · NCT04946721

• Anti-CD25 antibody to prevent acute GVHD after haploidentical stem cell transplant

  This study tests whether an anti-CD25 antibody can better prevent acute graft-versus-host disease after haploidentical hematopoietic stem cell transplantation compared with the usual methotrexate-based approach.

  Recruiting Phase 3 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07689630

• Ruxolitinib for Graft-Versus-Host Disease in Clinical Practice

  This study tests how well Jakavi (ruxolitinib) works and how safe it is for people with acute or chronic GVHD being treated in real-world medical settings.

  Recruiting Novartis · Tokyo · NCT07594587

• Moxibustion with second-line treatment for steroid-refractory acute graft-versus-host disease after transplant

  This study will test whether adding moxibustion to standard second-line drug therapy helps people aged 14–65 with steroid-refractory gastrointestinal acute GVHD after an allogeneic stem cell transplant.

  Recruiting Phase 2 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07572669

• Cord blood transplant for children and young adults with blood cancers.

  This study will test whether a cord blood transplant given as a first or second transplant can help children and young adults with leukemia, myelodysplasia, or lymphoma who lack a matched donor.

  Recruiting Phase 2 Memorial Sloan Kettering Cancer Center · New York, New York · NCT07566377

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.