Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes

Withdrawn before enrolling · Phase 4

Conditions studied: Graft Vs Host Disease

In brief

To evaluate the safety and efficacy of Dextenza intracanalicular insert in patients with ocular graft-versus-host disease (GVHD).

Key facts

Study ID

NCT04728646

Run by

Massachusetts Eye and Ear Infirmary

People needed

0

Starts

2021-09-01

Expected to finish

2021-12-13

Last updated by the study team

2022-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients diagnosed as chronic ocular GVHD
• Age >= 18 years
• Corneal Fluorescein Staining ≥ 4
• Ocular Surface Disease Index ≥22.

You may not qualify if…

• 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

Where it is running

• Mass Eye and Ear — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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