Status:
WITHDRAWN
Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborating Sponsors:
Ocular Therapeutix, Inc.
Conditions:
Graft Vs Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To evaluate the safety and efficacy of Dextenza intracanalicular insert in patients with ocular graft-versus-host disease (GVHD).
Detailed Description
Allogenic hematopoietic stem cell transplantation (allo-HSCT) is a curative, established treatment modality for a variety of malignant and nonmalignant hematologic disorders. Despite an increase in pa...
Eligibility Criteria
Inclusion
- All patients diagnosed as chronic ocular GVHD
- Age \>= 18 years
- Corneal Fluorescein Staining ≥ 4
- Ocular Surface Disease Index ≥22.
Exclusion
- History of immune diseases other than GVHD, herpetic keratitis or ocular malignancy
- Treatment regimen changes with topical cyclosporine, autologous serum, anakinra, or oral tetracycline compounds within 30 days prior to enrollment;
- Treatment regimen changes with systemic immunosuppressants or topical anti-glaucoma medications within 15 days prior to enrollment
- Current use of topical steroids more than twice a day
- Current or history of steroid induced ocular hypertension or glaucoma
- Family history of steroid induced ocular hypertension or glaucoma
- History of any intra-ocular surgery in the past 3 months or contact lens use within 2 weeks prior to enrollment
- History of collagen (prolong) intra-canalicular plug within 6 months
- Inability to cooperate for a comprehensive ocular examination
- History of lid deformity or neuroparalytic lid disease
- Active ocular infection including herpetic disease
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04728646
Start Date
September 1 2021
End Date
December 13 2021
Last Update
January 5 2022
Active Locations (1)
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1
Mass Eye and Ear
Boston, Massachusetts, United States, 02114