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NCT06852768 · ClinicalTrials.gov registry record · Phase 1

Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)

A Phase 1 study of oGHVD, sponsored by Regenerative Ocular Immunobiologics.

Recruiting
Registry status
Phase 1
Development phase
1
Enrollment target
5
Study locations

NCT06852768: Recruiting Phase 1 study of oGHVD, sponsored by Regenerative Ocular Immunobiologics.

NCT06852768 is a Phase 1 study of oGHVD that is actively recruiting participants, run by Regenerative Ocular Immunobiologics. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06852768, a Phase 1 study of oGHVD, is actively recruiting participants, sponsored by Regenerative Ocular Immunobiologics.

RECRUITING
Registry status
Phase 1
Development phase
1 participants
Enrollment target
5
Study locations

Study 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)

Primary Outcome

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 ±

Conditions Studied

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL d-MAPPS
  • OTHER PI and Patient Masked

Study Locations (5)

California

  • Beverly Hills Institute of Ophthalmology - Beverly Hills
  • Beach Eye Medical Group - Huntington Beach

Florida

  • Regenerative Ocular Immunobiologics, LLC. - Palm Harbor

Kentucky

  • Glenn Eye Center - Lexington

Massachusetts

  • Eyewell, LLC. - Boston

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2025-01-10
Est. Completion 2026-12
Phase Phase 1

What NCT06852768 shows while recruiting

NCT06852768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).

The record links to 1 condition, with oGHVD appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT06852768 lists 5 locations in 4 states (California, Florida, Kentucky).

Frequently Asked Questions

What is clinical trial NCT06852768 about?

NCT06852768 is a clinical study titled "Study of d-MAPPS™ Ophthalmic Solution, Safety, Tolerability, and Efficacy 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)

What is the current status of trial NCT06852768?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2025-01-10. Estimated completion is 2026-12.

What conditions does trial NCT06852768 study?

This clinical trial studies the following conditions: oGHVD.

What interventions are being tested in trial NCT06852768?

The interventions under investigation include: Placebo (BIOLOGICAL), d-MAPPS (BIOLOGICAL), PI and Patient Masked (OTHER).

Who is sponsoring clinical trial NCT06852768?

This trial is sponsored by Regenerative Ocular Immunobiologics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06852768 being conducted?

This trial has 5 study locations across California, Florida, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06852768's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06852768, the US trial registry maintained by the National Library of Medicine. NCT06852768 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.