Status:
AVAILABLE
Expanded Access for d-MAPPS™ Ophthalmic Solution, in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)
Lead Sponsor:
Regenerative Ocular Immunobiologics LLC
Conditions:
oGVHD
Eligibility:
All Genders
18+ years
Brief Summary
Regenerative Ocular Immunobiologics, LLC Fast Track Expanded Access This Expanded Access Policy describes the conditions under which ROI may make its investigational product - Sterile Processed Derive...
Detailed Description
Regenerative Ocular Immunobiologics, LLC ("ROI") is committed to advancing innovative regenerative biologics for serious ocular conditions with high unmet medical need. The investigational product, d-...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Willing and able to provide written informed consent.
- Willing and able to comply with study assessments for the full duration of the study.
- Patients may be using bilateral scleral lenses and/or bilateral punctal plugs at the time of accrual.
- Minimum Oxford Schema grade of ≥1 in at least one eye.
- OSDI score of ≥22.
- UNC DEMS score of ≥3.
- In good stable overall health
- Note: If the patient has no exclusion criteria, investigator can combine the Pre-screen and Baseline visit
Exclusion
- History of Rheumatoid Arthritis, Lupus, Scleroderma. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution).
- Ocular or periocular malignancy.
- Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.
- Any history of topical tacrolimus use (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution).
- Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.
- Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry.
- Current use of topical steroids more than twice a day.
- Corneal epithelial defect \>1mm2.
- Any history of herpetic keratitis. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution).
- Participation in another simultaneous medical research study.
- Signs of current infection, including fever and current treatment with antibiotics.
- All vaccinations including COVID are prohibited during this study.
- Intra-ocular surgery or ocular laser surgery within 3 months. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution following surgery.)
- Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study.)
- Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT07210619
Last Update
October 10 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.