Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegenerative Ocular Immunobiologics LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
d-MAPPS™ Ophthalmic Solution
Biological/VaccineSterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.
Matching vehicle control
Biological/VaccineMatching vehicle control supplied in identical masked containers and administered as two drops into each eye four times daily for 90 consecutive days.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Vehicle ControlledPlacebo comparator 1 intervention
Group B: Active Study DrugExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov