Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07776210
PHASE3

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

Sponsor: Regenerative Ocular Immunobiologics LLC

View on ClinicalTrials.gov

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). Eligible subjects will receive masked study treatment for 90 days, with the primary efficacy assessment performed at the Day 90 study visit.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-08-19

Completion Date

2027-06-30

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

d-MAPPS™ Ophthalmic Solution

Sterile, preservative-free ophthalmic solution administered as two drops into each eye four times daily for 90 consecutive days.

BIOLOGICAL

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.

Locations (1)

Regenerative Ocular Immunobiologics, LLC.

Palm Harbor, Florida, United States