TAHOE: Intravitreal Dexamethasone Implant (Ozurdex) for Uveitic Macular Edema
TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 24, 2013
CompletedFirst Posted
Study publicly available on registry
June 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedMarch 11, 2015
March 1, 2015
1.8 years
May 24, 2013
March 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best Corrected Visual Acuity (using Early Treatment Diabetic Retinopathy Study Protocal)
Day 90
Secondary Outcomes (3)
Central Subfoveal Retinal Thickness
Day 90
Central Subfoveal Retinal Thickness
Day 180
Best Corrected Visual Acuity
Day 180
Study Arms (1)
Ozurdex Injection
EXPERIMENTALOzurdex Intravitreal Injection (0.7 mg)
Interventions
Intravitreal Injection
Eligibility Criteria
You may qualify if:
- Uveitis CME with central subfoveal thickness \> 350 microns
- non-infectious uveitis
- Visual Acuity \> 20/32
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northern California Retina Vitreous Associateslead
- Allergancollaborator
Study Sites (1)
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
Related Publications (1)
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.
PMID: 21220619BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 24, 2013
First Posted
June 6, 2013
Study Start
May 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
March 11, 2015
Record last verified: 2015-03