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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

• All patients diagnosed as chronic ocular GVHD

• Age >= 18 years

• Corneal Fluorescein Staining ≥ 4

• Ocular Surface Disease Index ≥22.

Exclusion Criteria:

• 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