TAHOE: Intravitreal Dexamethasone Implant (Ozurdex) for Uveitic Macular Edema
Primary Purpose
Macular Edema, Uveitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ozurdex Intravitreal Injection (0.7 mg)
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring Uveitis, Macular Edema
Eligibility Criteria
Inclusion Criteria:
- Uveitis CME with central subfoveal thickness > 350 microns
- non-infectious uveitis
- Visual Acuity > 20/32
Exclusion Criteria:
- Visual Acuity worse than 20/200
- Moderate or severe glaucoma (as defined as >2 topical ocular medications)
- Infectious uveitis
- Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections, and fungal diseases.
- Aphakic eyes with rupture of the posterior lens capsule
- Anterior Chamber intraocular Lens and rupture of the posterior lens capsule
- Hypersensitivity to any components of the Ozurdex
Sites / Locations
- Northern California Retina Vitreous Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ozurdex Injection
Arm Description
Ozurdex Intravitreal Injection (0.7 mg)
Outcomes
Primary Outcome Measures
Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)
Secondary Outcome Measures
Central Subfoveal Retinal Thickness
Central Subfoveal Retinal Thickness
Best Corrected Visual Acuity
Full Information
NCT ID
NCT01870440
First Posted
May 24, 2013
Last Updated
March 9, 2015
Sponsor
Northern California Retina Vitreous Associates
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01870440
Brief Title
TAHOE: Intravitreal Dexamethasone Implant (Ozurdex) for Uveitic Macular Edema
Official Title
TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern California Retina Vitreous Associates
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether an intravitreal dexamethasone implant (Ozurdex, Allergan) is effective to manage macular edema secondary to non-infectious uveitis.
Detailed Description
Uveitis accounts for more than 10% of all cases of severe vision loss in developed countries, which makes it possibly the fourth leading cause of blindness in the United States. Cystoid macular edema (CME) is the most structural complication of uveitis, resulting in visual impairment and blindness. If left untreated or undertreated over a period of years, CME may result in permanent photoreceptor damage of the macula and loss of central vision. Further, CME may persist despite adequate control of the uveitis, and therefore, adjuvant therapy to specifically treat the CME may be required.
We propose to study whether a sustained steroid delivery system (Ozurdex, Allergan) can treat uveitic macular edema. Ozurdex has been proven to be effective for non-infectious posterior uveitis; and FDA approved for posterior uveitis. The sustained delivery of the steroid and local delivery modality makes it an ideal candidate to manage macular edema in uveitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Uveitis
Keywords
Uveitis, Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ozurdex Injection
Arm Type
Experimental
Arm Description
Ozurdex Intravitreal Injection (0.7 mg)
Intervention Type
Drug
Intervention Name(s)
Ozurdex Intravitreal Injection (0.7 mg)
Other Intervention Name(s)
Ozurdex (0.7 mg)
Intervention Description
Intravitreal Injection
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Central Subfoveal Retinal Thickness
Time Frame
Day 90
Title
Central Subfoveal Retinal Thickness
Time Frame
Day 180
Title
Best Corrected Visual Acuity
Time Frame
Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Uveitis CME with central subfoveal thickness > 350 microns
non-infectious uveitis
Visual Acuity > 20/32
Exclusion Criteria:
Visual Acuity worse than 20/200
Moderate or severe glaucoma (as defined as >2 topical ocular medications)
Infectious uveitis
Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infections, and fungal diseases.
Aphakic eyes with rupture of the posterior lens capsule
Anterior Chamber intraocular Lens and rupture of the posterior lens capsule
Hypersensitivity to any components of the Ozurdex
Facility Information:
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21220619
Citation
Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.
Results Reference
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TAHOE: Intravitreal Dexamethasone Implant (Ozurdex) for Uveitic Macular Edema
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