NCT07776210 · Regenerative Ocular Immunobiologics LLC
Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)
What this study is about
This is a Phase III, conducted at multiple hospitals, randomly assigned, double-masked, vehicle-controlled, parallel-group clinical trial designed to evaluate the effectiveness, safety, and tolerability of d-MAPPS™ Ophthalmic Solution in adult subjects with chronic ocular graft-versus-host disease (oGVHD).
View original scientific description
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.
Interventions
BIOLOGICAL
d-MAPPS™ Ophthalmic Solution
Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.
BIOLOGICAL
Matching vehicle control
Matching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days.
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Beverly Hills, California
- Palm Harbor, Florida
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations