oGVHDPhase 3NCT07776210
Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)
A Phase 3 study testing d-MAPPS™ Ophthalmic Solution in people with oGVHD and Ocular Graft Versus Host Disease, run by Regenerative Ocular Immunobiologics LLC at 5 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- oGVHD, Ocular Graft Versus Host Disease
- What is being tested?
- d-MAPPS™ Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Sep 2026to 30 Jun 2027
- Phase
- Phase 3
- 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 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, 90210
Jillian Chong, MD, 310-273-2333, drchong@90210eyes.com
Jillian Chong, MD
- Recruiting
Beverly Hills Optometry
Beverly Hills, California, 90211
Kambiz Silani, OD, 310-659-2020
bheyeguy@gmail.com
- Recruiting
Eyewell, LLC.
Boston, Massachusetts, 02215
Kristen Brown, OD, (617) 433-9895, kristen.brown@myeyewell.com
Kristen Brown, OD
- Recruiting
BostonSight
Boston, Massachusetts, 02494
Daniel C. Brocks, MD, 781-726-7337, DBrocks@bostonsight.org
Daniel C. Brocks, MD
- Not yet recruiting
Regenerative Ocular Immunobiologics, LLC.
Palm Harbor, Florida, 34684
Marissa Harrell, CEO, PhD, 727-748-0420, Marissa@roiglobalsolutions.org
Craig Hull, COO, 727-460-4116, Craig@roiglobalsolutions.org
About this study
Official 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)
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.
- Conditions
- oGVHD, Ocular Graft Versus Host Disease
- Being tested
- d-MAPPS™ Ophthalmic Solution, Matching vehicle control
- Keywords
- oGVHD, Ocular Graft-Versus-Host Disease, Ocular Graft Versus Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
d-MAPPS™ Ophthalmic SolutionBiological
Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.
Matching vehicle controlBiological
Matching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Vehicle Controlled | Placebo comparator | Not described Receives: Biological: Matching vehicle control |
| Active Study Drug | Experimental | Not described Receives: Biological: d-MAPPS™ Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Day 90 (±5 days)
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Randomization through Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start8 Sep 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for oGVHDStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 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
- NCT07776210
- Sponsor's protocol ID
- IND 30066-PIVOT
- Status last verified
- Nov 2026
- First submitted
- 17 Aug 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07776210
- Acronym / sponsor ID
- IND 30066-PIVOT
- Conditions
- oGVHD, Ocular Graft Versus Host Disease
- Keywords
- oGVHD, Ocular Graft-Versus-Host Disease, Ocular Graft Versus Host Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Regenerative Ocular Immunobiologics LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 20 Aug 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vehicle Controlled | Placebo comparator | Biological: Matching vehicle control |
| Active Study Drug | Experimental | Biological: d-MAPPS™ Ophthalmic Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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-MAPPS™ Ophthalmic SolutionSterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days. | Biological | Active Study Drug |
| Matching vehicle controlMatching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days. | Biological | Vehicle Controlled |
Primary outcome
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.
15 secondary outcomes
Percentage of Participants With a ≥1-Grade Decrease in Modified Oxford Corneal Staining Score
Time frame: Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in Supportive Efficacy Measures in the Fellow Eye
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants With Modified Oxford Corneal Staining Score Grade 0 at Day 90
Time frame: Day 90 (±5 days)
Change From Baseline to Day 90 in Superficial Punctate Keratitis (SPK) Severity
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants With a ≥1-Grade Decrease in Superficial Punctate Keratitis (SPK) Severity
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants With Superficial Punctate Keratitis (SPK) Severity of 0 at Day 90
Time frame: Day 90 (±5 days)
Percentage of Participants With a ≥13-Point Decrease in OSDI Total Score
Time frame: Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in NIH Eye Score
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants With a ≥1-Grade Decrease in NIH Eye Score
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants With No Worsening in NIH Eye Score at Day 90
Time frame: Baseline to Day 90 (±5 days)
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 Tear Break-Up Time (TBUT)
Time frame: Baseline to Day 90 (±5 days)
Percentage of Participants Receiving Protocol-Defined Rescue Therapy
Time frame: Randomization through Day 90
Time to First Administration of Protocol-Defined Rescue Therapy
Time frame: Randomization through Day 90
Percentage of Participants With Protocol-Defined Treatment Failure
Time frame: Randomization through Day 90
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 3 Nov 2026.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing d-MAPPS™ Ophthalmic Solution in people with oGVHD and Ocular Graft Versus Host Disease, run by Regenerative Ocular Immunobiologics LLC at 5 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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Marissa Harrell, PhD (727-748-0420, info@roiglobalsolutions.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Day 90 in Modified Oxford Corneal Staining Score (time frame: Baseline to Day 90 (±5 days)). 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 3 Nov 2026.