Study of the Effectiveness of Ozurdex for the Control of Uveitis

NCT02049476 | Completed Phase 4 Results

• 1 other identifier: NA_00088146
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate whether or not the dexamethasone pellet (Ozurdex®, Allergan, Irvine, CA) can replace oral corticosteroid (e.g. prednisone) in the treatment of active sight-threatening, noninfectious intermediate and/or posterior uveitis in which immunosuppressive drug therapy is indicated. Uveitis is an inflammation inside the eye. Uveitis can decrease patients' vision if it is not treated. The dexamethasone pellet is an implant filled with a corticosteroid medicine. This therapy is approved by the Food and Drug Administration (FDA) for the treatment of intermediate and/or posterior uveitis. In this study investigators want to see if using the implant together with systemic immunosuppressive drug therapy can result in lower ocular side effect profile but is effective enough to replace the use of high-dose systemic corticosteroids in the treatment of active intermediate and/or posterior uveitis. Knowing the effectiveness and safety of these treatments is important because the kinds of uveitis being studied usually need to be treated for many years. This information may help researchers understand uveitis better and may suggest ways of improving treatment. Adult patients with intermediate and/or posterior uveitis for which immunosuppressive drug therapy with high-dose corticosteroid is planned may join.

Conditions

Uveitis, Intermediate; Uveitis, Posterior

Keywords

Uveitis, Intermediate; Uveitis, Posterior; Dexamethasone; Immunosuppressive Agents; Eye Abnormalities; Eye Diseases; Ophthalmology; Ophthalmologic Surgical Procedures; Vision Disorders; Inflammation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Absence of Intraocular Inflammation at 6 Months

  Absence of intraocular inflammation (e.g. less than trace anterior chamber (AC) cells; no vitreous haze; inactive chorioretinal lesions) is used to assess control of intraocular inflammation following treatment.

  at 6-month visit

Secondary Outcomes (1)

• Number of Participants With Absence of Intraocular Inflammation at 12 Months

  12-month clinical visit

Other Outcomes (2)

• Mean Intraocular Pressure (IOP)

  Baseline, 1 month, 3 months, 6 months, and 12 months visit

• Number of Eyes With a Need for Cataract Surgery

  Baseline, 1 month, 3 months, 6 months, and 12 months visit

Study Arms (1)

Dexamethasone Pellet

EXPERIMENTAL

This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.

Drug: Dexamethasone pellet

Interventions

Dexamethasone pellet DRUG

Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination. Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol.

Also known as: Ozurdex pellet

Dexamethasone Pellet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active sight-threatening intermediate or posterior uveitis for which immunosuppressive drug therapy is planned and the physician is considering treatment with high-dose corticosteroid to control the uveitis whilst immunosuppressive drugs are being instituted or adjusted. Note: it is acceptable for the patient to already be on an immunosuppressive drug as long as high dose corticosteroids are indicated.
• Patients must be age 18 years or older (the dexamethasone pellet is not FDA-approved for pediatric use) and sign an informed consent.
• The ocular media must be clear enough to obtain optical coherence photography (OCT) and fundus photographs.
• No elective intraocular surgery should be planned for the first 3 months after enrollment.

You may not qualify if:

• Infectious uveitis
• History of scleritis
• Active or suspected viral infection of the cornea or conjunctiva
• History of mycobacterial or fungal disease
• HIV positivity
• Age \<18 years old
• Allergy to dexamethasone
• Uncontrolled intraocular pressure (IOP)
• Advanced glaucoma
• Aphakia with rupture of the posterior lens capsule
• Anterior chamber IntraOcualr Lens (ACIOL) with rupture of the posterior lens capsule
• Media opacity that would preclude evaluation of the posterior pole via fundus photography or OCT assessment
• Planned elective ocular surgery within 3 months of enrollment
• Any systemic disease requiring systemic corticosteroids.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Allergan: collaborator

Study Sites (1)

The Wilmer Eye Institute, Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Uveitis, Intermediate; Uveitis, Posterior; Eye Abnormalities; Eye Diseases; Vision Disorders; Inflammation

Condition Hierarchy (Ancestors)

Uveitis; Uveal Diseases; Panuveitis; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Results Point of Contact

• Title: Jennifer E. Thorne, MD, PhD; Professor of Ophthalmology & Epidemiology,Director of Ocular Immunology
• Organization: Wilmer Eye Institute, Johns Hopkins University School of Medicine

jthorne@jhmi.edu

410-955-2966

Study Officials

• Jennifer E Thorne, MD, PhD

  Department of Ophthalmology, Johns Hopkins School of Medicine,

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 30, 2014
• Study Start: January 1, 2014
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-06

Locations

US (1)