Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 4 for:    "Choroiditis" | "BB 1101"

Study of the Effectiveness of Ozurdex for the Control of Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02049476
Recruitment Status : Completed
First Posted : January 30, 2014
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Johns Hopkins University

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.


Condition or disease Intervention/treatment Phase
Uveitis, Intermediate Uveitis, Posterior Drug: Dexamethasone pellet Phase 4

Detailed Description:

Objectives: This is a single arm study evaluating 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 or posterior uveitis in which immunosuppressive drug therapy is indicated.

Background: Intermediate and posterior uveitis are thought to be severe intraocular inflammation that may lead to permanent visual loss. It is estimated that these forms of uveitis comprise the fifth or sixth leading cause of blindness and tend to affect working class age patients, thus causing loss of work hours and diminished productivity and quality of life. Because the posterior segment of the eye is not adequately treated by corticosteroid drops often systemic drug therapy is used including oral corticosteroids or prednisone. Prednisone can have a myriad of side effects in approximately one-quarter to one-third of cases treated in tertiary care centers such as ours, additional medications such as immunosuppressive drugs are required to control the disease and/or to allow for appropriate tapering of oral prednisone to subsequent levels that have a low side effect profile when delivered over a long period of time. Typically, chronic prednisone therapy in doses of 7.5 mg daily or less are thought to have a low enough side effect profile to be amenable to long-term therapy. However frequently immunosuppressive drugs are required to get the dosing to this level. There are occasions when patients are intolerant of any dose of oral corticosteroids or are intolerant of the higher doses of oral corticosteroids (30 - 60 mg daily) and therefore this treatment modality is avoided due to prednisone's attendant side effects. Although periocular and intravitreal corticosteroids injections may be performed, with these modalities the standard of care is to wait until the disease reactivates before instituting such therapy and therefore a chronic suppressive dose is not obtained. The fluocinolone acetonide implant (Retisert®, Bausch and Lomb, Tampa, FL) is FDA-approved for the treatment of intermediate and posterior uveitis and it is equally effective in controlling uveitis as high-dose oral corticosteroids but avoids the systemic side effects associated with the use of high doses of oral corticosteroids. However, this form of local therapy has high rates of ocular side effects, including ocular hypertension causing glaucoma and/or requiring glaucoma surgery and cataracts. Furthermore, every two and half to three years the implant is exhausted of corticosteroid and therefore repeat surgical insertion of another implant may be required. A useful potential therapy for the treatment of these patients would be a shorter-acting local corticosteroid that could be delivered in conjunction with systemic immunosuppressive drug therapy that would have a lower ocular side effect profile but still would be effective enough to replace the use of high-dose systemic corticosteroids in the treatment of active intermediate or posterior uveitis. It is possible that the dexamethasone pellet could fill this unique role in the treatment of uveitis. Investigators propose this study to evaluate dexamethasone pellet for this specific use among patients with active intermediate and posterior uveitis.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proof of Concept Study of the Effectiveness of Ozurdex in Lieu of Oral Corticosteroids for the Control of Active Intermediate and Posterior Uveitis Requiring Immunosuppressive Drug Therapy
Study Start Date : January 2014
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018


Arm Intervention/treatment
Experimental: Dexamethasone Pellet
This is a proof of concept study; therefore all enrolled patients will receive the intervention according to its FDA-approved indication.
Drug: Dexamethasone pellet

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.

Other Name: Ozurdex pellet




Primary Outcome Measures :
  1. Number of Participants With Absence of Intraocular Inflammation at 6 Months [ Time Frame: at 6-month visit ]
    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.


Secondary Outcome Measures :
  1. Number of Participants With Absence of Intraocular Inflammation at 12 Months [ Time Frame: 12-month clinical visit ]
    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.


Other Outcome Measures:
  1. Mean Intraocular Pressure (IOP) [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months visit ]
    Mean IOP (mmHg) was calculated at each visit

  2. Number of Eyes With a Need for Cataract Surgery [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months visit ]
    Number of eyes that had progression of cataract defined as any interval increase in nuclear, cortical or posterior sub capsular cataract from a previous visit that resulted in cataract surgery.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049476


Locations
Layout table for location information
United States, Maryland
The Wilmer Eye Institute, Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Allergan
Investigators
Layout table for investigator information
Principal Investigator: Jennifer E Thorne, MD, PhD Department of Ophthalmology, Johns Hopkins School of Medicine,
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02049476     History of Changes
Other Study ID Numbers: NA_00088146
First Posted: January 30, 2014    Key Record Dates
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019
Last Verified: June 2019
Keywords provided by Johns Hopkins University:
Uveitis, Intermediate
Uveitis, Posterior
Dexamethasone
Immunosuppressive Agents
Eye Abnormalities
Eye Diseases
Ophthalmology
Ophthalmologic Surgical Procedures
Vision Disorders
Inflammation
Additional relevant MeSH terms:
Layout table for MeSH terms
Choroiditis
Dexamethasone
Dexamethasone acetate
BB 1101
Uveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Panuveitis
Choroid Diseases
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action