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

NCT ID: NCT04728646

Last Updated: 2022-01-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2021-12-13

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 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.

Conditions

Graft Vs Host Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

All patients will receive Dextenza insert in one eye and a regular dissolvable intracanalicular plug in the fellow-eye (randomized).

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Inserted During Screening/Baseline: Day Zero in either the right or left eye (depending on randomization)

Dissolvable intracanalicular plug

All patients will receive Dextenza insert in one eye and a regular dissolvable intracanalicular plug in the fellow-eye (randomized).

Group Type: OTHER

Regular dissolvable intracanalicular plug

Intervention Type: DEVICE

Inserted During Screening/Baseline: Day Zero in either the right or left eye (depending on randomization)

Interventions

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

Inserted During Screening/Baseline: Day Zero in either the right or left eye (depending on randomization)

Intervention Type: DRUG

Regular dissolvable intracanalicular plug

Inserted During Screening/Baseline: Day Zero in either the right or left eye (depending on randomization)

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role: collaborator

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Reza Dana, MD

Professor, Director of Epidemiology for Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mass Eye and Ear

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2020P003125

Identifier Type: -

Identifier Source: org_study_id