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Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)

3 september 2026 bijgewerkt door: Regenerative Ocular Immunobiologics LLC

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Fase 3

Uitgebreide toegang

Verkrijgbaar buiten de klinische proef. Zie uitgebreid toegangsrecord.

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • Beverly Hills, California, Verenigde Staten, 90210
        • Werving
        • Beverly Hills Institute of Ophthalmology
        • Contact:
        • Hoofdonderzoeker:
          • Jillian Chong, MD
      • Beverly Hills, California, Verenigde Staten, 90211
        • Werving
        • Beverly Hills Optometry
        • Contact:
          • Kambiz Silani, OD
          • Telefoonnummer: 310-659-2020
        • Contact:
        • Hoofdonderzoeker:
          • Kambiz Silani, OD
    • Florida
      • Palm Harbor, Florida, Verenigde Staten, 34684
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Werving
        • Eyewell, LLC.
        • Contact:
        • Hoofdonderzoeker:
          • Kristen Brown, OD
      • Boston, Massachusetts, Verenigde Staten, 02494
        • Werving
        • BostonSight
        • Contact:
        • Hoofdonderzoeker:
          • Daniel C. Brocks, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Vehicle Controlled
Biologisch: 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.
Experimenteel: Active Study Drug
Biologisch: d-MAPPS™ Ophthalmic Solution
Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change From Baseline to Day 90 in Modified Oxford Corneal Staining Score
Tijdsspanne: 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.
Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in Ocular Surface Disease Index (OSDI) Total Score
Tijdsspanne: 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.
Baseline to Day 90 (±5 days)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With a ≥1-Grade Decrease in Modified Oxford Corneal Staining Score
Tijdsspanne: Baseline to Day 90 (±5 days)
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.
Baseline to Day 90 (±5 days)
Percentage of Participants With a ≥13-Point Decrease in OSDI Total Score
Tijdsspanne: Baseline to Day 90 (±5 days)
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.
Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in Tear Break-Up Time (TBUT)
Tijdsspanne: Baseline to Day 90 (±5 days)
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.
Baseline to Day 90 (±5 days)
Percentage of Participants Receiving Protocol-Defined Rescue Therapy
Tijdsspanne: Randomization through Day 90
The proportion of participants receiving at least one administration of protocol-defined rescue therapy during the randomized treatment period.
Randomization through Day 90
Time to First Administration of Protocol-Defined Rescue Therapy
Tijdsspanne: Randomization through Day 90
Time from randomization to the first administration of protocol-defined rescue therapy.
Randomization through Day 90
Percentage of Participants With Protocol-Defined Treatment Failure
Tijdsspanne: Randomization through Day 90
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.
Randomization through Day 90
Change From Baseline to Day 90 in Supportive Efficacy Measures in the Fellow Eye
Tijdsspanne: Baseline to Day 90 (±5 days)
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.
Baseline to Day 90 (±5 days)
Percentage of Participants With Modified Oxford Corneal Staining Score Grade 0 at Day 90
Tijdsspanne: Day 90 (±5 days)
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.
Day 90 (±5 days)
Change From Baseline to Day 90 in Superficial Punctate Keratitis (SPK) Severity
Tijdsspanne: Baseline to Day 90 (±5 days)
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.
Baseline to Day 90 (±5 days)
Percentage of Participants With a ≥1-Grade Decrease in Superficial Punctate Keratitis (SPK) Severity
Tijdsspanne: Baseline to Day 90 (±5 days)
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.
Baseline to Day 90 (±5 days)
Percentage of Participants With Superficial Punctate Keratitis (SPK) Severity of 0 at Day 90
Tijdsspanne: Day 90 (±5 days)
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.
Day 90 (±5 days)
Change From Baseline to Day 90 in NIH Eye Score
Tijdsspanne: Baseline to Day 90 (±5 days)
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.
Baseline to Day 90 (±5 days)
Percentage of Participants With a ≥1-Grade Decrease in NIH Eye Score
Tijdsspanne: Baseline to Day 90 (±5 days)
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.
Baseline to Day 90 (±5 days)
Percentage of Participants With No Worsening in NIH Eye Score at Day 90
Tijdsspanne: Baseline to Day 90 (±5 days)
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.
Baseline to Day 90 (±5 days)
Change From Baseline to Day 90 in UNC Dry Eye Management Scale Visual Analog Scale Score
Tijdsspanne: Baseline to Day 90 (±5 days)
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.
Baseline to Day 90 (±5 days)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Regenerative Ocular Immunobiologics LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

31 maart 2027

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

17 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 augustus 2026

Eerst geplaatst (Werkelijk)

20 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 september 2026

Laatste update ingediend die voldeed aan QC-criteria

3 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • IND 30066-PIVOT

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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