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

Mass Eye and Ear

Status and phase

Withdrawn

Phase 4

Conditions

Graft Vs Host Disease

Treatments

Drug: DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use

Device: Regular dissolvable intracanalicular plug

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04728646

2020P003125

Details and patient eligibility

About

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

Full 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 patient survival with HSCT, Graft-Versus-Host Disease (GVHD), in which donor immune cells detect recipient cells as foreign and attack the host tissue, is associated with significant morbidity and mortality after allo-HSCT. Ocular surface involvement is one of the most common manifestations of chronic GVHD with up to 60-90% of patients affected. Dry eye (DE) is the typical finding in ocular GVHD, and severe, chronic inflammation plays a crucial role in the pathogenesis. Therefore, topical steroids have been commonly used in patients with ocular GVHD (oGVHD). Although a healing effect of topical steroids has been shown in oGVHD, the efficacy of treatment might be reduced if it is not applied appropriately; poor patient compliance and improper drop administration (such as missing the eye and instilling an insufficient amount of medication) might diminish medication efficacy. Additionally, even if drops are applied appropriately, only approximately 5% of the administered dose can reach the target tissue because of blinking, nasolacrimal drainage, and low corneal permeability. Furthermore, the intermittent administration of topical drops results in a variable drug concentration in the target tissue and produces a suboptimal pharmacologic effect. Additionally, the prolonged use of topical steroids can also be toxic to the ocular surface due to preservatives such as benzalkonium chloride, which is used for its anti-microbial properties to prevent the contamination of drops. This toxicity might further disrupt the corneal epithelial barrier, which is already disrupted because of existing ocular surface inflammation.

To address all of these obstacles associated with topical steroids in patients with oGVHD, a sustained-released preservative-free intracanalicular insert (Dextenza, Ocular Therapeutix) may be beneficial. The purpose of this clinical trial is evaluate the safety and efficacy of Dextenza intracanalicular inserts in patients with ocular GVHD.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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