NCT06852768

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 (oGVHD)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (estimated)
• Sponsor: Regenerative Ocular Immunobiologics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• oGHVD

Interventions

Type	Name	Description
BIOLOGICAL	d-MAPPS	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.
BIOLOGICAL	Placebo	Based on randomization, Placebo, will be self-administered, 2 drops into each eye four times (QID) a day for ninety (90) days.
OTHER	PI and Patient Masked	Both the PI and the participant are masked on the drug administered.

Timeline

• Start date: 2025-01-10
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-02-28
• Last updated: 2026-04-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study