oGHVDPhase 1/2oGVHDNCT06852768
Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
A Phase 1/2 study testing d-MAPPS and PI and Patient Masked in people with oGHVD, run by Regenerative Ocular Immunobiologics LLC at 6 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- oGHVD
- What is being tested?
- d-MAPPS and PI and Patient Masked
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 6 sitesUnited States
- Study dates
- 10 Jan 2025to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of childbearing potential, unwillingness to use effective birth control while participating in the study.
- Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, 90210
Eyewell, LLC.
Boston, Massachusetts, 02215
BostonSight
Boston, Massachusetts, 02494
Beach Eye Medical Group
Huntington Beach, California, 92648
Glenn Eye Center
Lexington, Kentucky, 40511
Regenerative Ocular Immunobiologics, LLC.
Palm Harbor, Florida, 34684
About this study
Official title: 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 (oGVHD)
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
- Being tested
- d-MAPPS, Placebo, PI and Patient Masked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-MAPPSBiological
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.
PlaceboBiological
Based on randomization, Placebo, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
PI and Patient MaskedOther
Both the PI and the participant are masked on the drug administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: d-MAPPS; Biological: Placebo; Other: PI and Patient Masked |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 4 months.
Secondary outcomes (2)
Changes from baseline utilizing the NIH Eye Score for chronic oGVHD
The NIH Eye Score is a recommended measure, as it detects improvement or worsening in ocular chronic GVHD. Scoring from 0 to 3 is based on symptoms, need for eye drops, and use of therapeutic procedures or devices.
Measured: Through study completion, an average of 4 months.
Changes from Baseline Oxford Schema for Corneal and Conjunctival Stain Grades
Oxford Schema for Corneal and Conjunctival Staining is a diagnostic test that looks for signs of damage or dryness in the eye. It involves a doctor applying dye to the eye to show areas of damage on its surface. The Oxford grading scale divides corneal staining into 6 groups according to severity: 0 = absent, I = minimal, II = mild, III = moderate, IV = marked, and V = severe. The changes will be evaluated from baseline and at timepoints 30 ±5 days, 60 ±5 days and 90±5 days.
Measured: Through study completion, an average of 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start10 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for oGHVDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regenerative Ocular Immunobiologics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852768
- Sponsor's protocol ID
- 30066
- Acronym
- oGVHD
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 (oGVHD)
- ClinicalTrials.gov ID
- NCT06852768
- Acronym / sponsor ID
- oGVHD / 30066
- Conditions
- oGHVD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Regenerative Ocular Immunobiologics LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| This arm randomizes the actual drug to the patient. | Active comparator | Biological: d-MAPPSBased on randomization, d-MAPPS™ will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days. |
| This arm randomizes the placebo to the patient. | Placebo comparator | Biological: PlaceboBased on randomization Placebo/sterile water, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days. |
| Both patient and PI are masked. | Other | Biological: d-MAPPS, Biological: Placebo, Other: PI and Patient MaskedUpon 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| d-MAPPSBased on randomization d-MAPPS, will be self-administered, 2 drops into each eye four times a day (QID) a day for ninety (90) days. | Biological | Both patient and PI are masked., This arm randomizes the actual drug to the patient. |
| PlaceboBased on randomization, Placebo, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days. | Biological | Both patient and PI are masked., This arm randomizes the placebo to the patient. |
| PI and Patient MaskedBoth the PI and the participant are masked on the drug administered. | Other | Both patient and PI are masked. |
Primary outcome
Changes from Baseline utilizing University of North Carolina Dry Eye Management Scale (UNC DEMS) Scores
Time frame: Through study completion, an average of 4 months.
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.
Changes from Baseline utilizing Ocular Surface Disease Index (OSDI)
Time frame: Through study completion, an average of 4 months.
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.
2 secondary outcomes
Changes from baseline utilizing the NIH Eye Score for chronic oGVHD
Time frame: Through study completion, an average of 4 months.
Changes from Baseline Oxford Schema for Corneal and Conjunctival Stain Grades
Time frame: Through study completion, an average of 4 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing d-MAPPS and PI and Patient Masked in people with oGHVD, run by Regenerative Ocular Immunobiologics LLC at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline utilizing University of North Carolina Dry Eye Management Scale (UNC DEMS) Scores (time frame: Through study completion, an average of 4 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.