A Phase 3 interventional study of d-MAPPS™ Ophthalmic Solution and Matching vehicle control in oGVHD and Ocular Graft Versus Host Disease, sponsored by Regenerative Ocular Immunobiologics LLC. Recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Regenerative Ocular Immunobiologics LLC · Phase 3, Interventional, and Treatment
Among 454 studies in Graft vs Host Disease with a site in United States — 50 open to participants now, 71 under way, 2 of them phase 3. Graft vs Host Disease · United States.
Among the 454 studies in Graft vs Host Disease with a site in United States, this one is the 192nd largest by planned enrollment of the 389 interventional ones that give a count, is one of 14 that started in 2026, is one of 40 in phase 3, reaches primary completion later than 22 of the 66 other live ones, and was the 451st registered.
804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.
Browse Graft vs Host Disease studies →50 of the 454 studies in Graft vs Host Disease with a site in United States are open now. Recruiting first, the newest first:
City of Hope Medical Center · Sites in United States
Memorial Sloan Kettering Cancer Center · Sites in United States
Northwell Health · Sites in United States
Sawa Ito, MD · Sites in United States
City of Hope Medical Center · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 103 Graft vs Host Disease studies recruiting now, 51 (50%) set no upper age limit and 42 (41%) stop at 75 or younger; 42 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
454 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 145 · Phase 2 227 · Phase 3 48 · Phase 4 5
First in 1986; this study’s year is marked. 14 started in 2026.
This study's planned enrollment of 30 is below the median of 35 across 639 interventional studies indexed under Graft vs Host Disease.
Median enrollment 30 across the 389 interventional studies, 81 across the 43 observational. Of the 347 that completed or were terminated, 166 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
80 of 454 have an industry lead sponsor. The 10 most frequent:
Regenerative Ocular Immunobiologics LLC is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Regenerative Ocular Immunobiologics LLC has 1 study filed under Graft vs Host Disease — fewer than ten, so there is no comparison to draw.
21 of the studies in Graft vs Host Disease with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07776210Phase 3Regenerative Ocular Immunobiologics LLCStudy of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD) | 2027-03-31 |
| NCT06649201Case Comprehensive Cancer CenterVulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation | 2026-11 |
| NCT05675930Memorial Sloan Kettering Cancer CenterA Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant | 2026-12-22 |
| NCT04044365National Cancer Institute (NCI)Pediatric cGVHD Symptom Scale | 2026-12-31 |
| NCT03533816University of Kansas Medical CenterExpanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide | 2027-01 |
Among the 454 studies in Graft vs Host Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Matching vehicle control
Biological: d-MAPPS™ Ophthalmic Solution
Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.
Matching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days.
Change From Baseline to Day 90 in Modified Oxford Corneal Staining Score
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.
Time frame: Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in Ocular Surface Disease Index (OSDI) Total Score
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.
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants With a ≥1-Grade Decrease in Modified Oxford Corneal Staining Score
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.
Time frame: Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in Supportive Efficacy Measures in the Fellow Eye
Supportive analyses will evaluate change from Baseline to Day 90 separately for protocol-defined measures collected in the fellow eye, including the Modified Oxford Corneal Staining score, superficial punctate keratitis (SPK) severity, and tear break-up time (TBUT). Modified Oxford scores range from 0 to 5, with higher scores indicating greater corneal staining; a decrease indicates improvement. Lower SPK severity indicates improvement. TBUT is measured in seconds; an increase indicates improved tear-film stability. No composite score will be calculated.
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants With Modified Oxford Corneal Staining Score Grade 0 at Day 90
The proportion of participants with a Modified Oxford Corneal Staining Score of Grade 0 in the prespecified study eye at Day 90. Scores range from 0 to 5, with higher scores indicating greater corneal staining and a worse outcome. Grade 0 indicates no corneal staining.
Time frame: Day 90 (±5 days)
Change From Baseline to Day 90 in Superficial Punctate Keratitis (SPK) Severity
Change from Baseline to Day 90 in the protocol-defined Superficial Punctate Keratitis (SPK) Severity Grade in the prespecified study eye. Grades range from 0 (no SPK) to 4 (severe SPK), with higher grades indicating greater severity and a worse outcome. A decrease indicates improvement.
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants With a ≥1-Grade Decrease in Superficial Punctate Keratitis (SPK) Severity
The proportion of participants achieving at least a 1-grade decrease from Baseline to Day 90 in the protocol-defined Superficial Punctate Keratitis (SPK) Severity Grade in the prespecified study eye. Grades range from 0 (no SPK) to 4 (severe SPK), with higher grades indicating greater severity and a worse outcome. A decrease indicates improvement.
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants With Superficial Punctate Keratitis (SPK) Severity of 0 at Day 90
The proportion of participants with a Superficial Punctate Keratitis (SPK) Severity Grade of 0 in the prespecified study eye at Day 90. Grades range from 0 (no SPK) to 4 (severe SPK), with higher grades indicating greater severity and a worse outcome. Grade 0 indicates complete resolution of SPK.
Time frame: Day 90 (±5 days)
Percentage of Participants With a ≥13-Point Decrease in OSDI Total Score
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.
Time frame: Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in NIH Eye Score
Change from Baseline to Day 90 in the National Institutes of Health (NIH) Eye Score. Scores range from 0 (no ocular symptoms) to 3 (severe ocular involvement), with higher scores indicating greater ocular graft-versus-host disease severity and a worse outcome. A decrease indicates improvement.
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants With a ≥1-Grade Decrease in NIH Eye Score
The proportion of participants achieving at least a 1-grade decrease from Baseline to Day 90 in the National Institutes of Health (NIH) Eye Score. Scores range from 0 (no ocular symptoms) to 3 (severe ocular involvement), with higher scores indicating greater ocular graft-versus-host disease severity and a worse outcome. A decrease indicates improvement.
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants With No Worsening in NIH Eye Score at Day 90
The proportion of participants whose National Institutes of Health (NIH) Eye Score at Day 90 is equal to or lower than their Baseline score. Scores range from 0 (no ocular symptoms) to 3 (severe ocular involvement), with higher scores indicating greater ocular graft-versus-host disease severity and a worse outcome. A lower score indicates improvement, while an unchanged score indicates no worsening.
Time frame: Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in UNC Dry Eye Management Scale Visual Analog Scale Score
Change from Baseline to Day 90 in the University of North Carolina Dry Eye Management Scale (UNC DEMS) Visual Analog Scale score. Scores range from 1 to 10, with higher scores indicating more severe dry-eye symptoms, greater effects on daily life, and a worse outcome. A decrease indicates improvement.
Time frame: Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in Tear Break-Up Time (TBUT)
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.
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants Receiving Protocol-Defined Rescue Therapy
The proportion of participants receiving at least one administration of protocol-defined rescue therapy during the randomized treatment period.
Time frame: Randomization through Day 90
Time to First Administration of Protocol-Defined Rescue Therapy
Time from randomization to the first administration of protocol-defined rescue therapy.
Time frame: Randomization through Day 90
Percentage of Participants With Protocol-Defined Treatment Failure
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.
Time frame: Randomization through Day 90
Started Sep 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.
Of 31 phase 3 interventional studies under Graft vs Host Disease, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 48. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Regenerative Ocular Immunobiologics LLC