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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00168298
Registration number
NCT00168298
Ethics application status
Date submitted
12/09/2005
Date registered
15/09/2005
Date last updated
23/04/2019
Titles & IDs
Public title
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
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Scientific title
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Secondary ID [1]
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206207-009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Macular Edema
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Retinal Vein Occlusion
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 700 µg Dexamethasone
Treatment: Drugs - 350 µg Dexamethasone
Other interventions - Sham Injection
Experimental: 700 µg Dexamethasone - 700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
Experimental: 350 µg Dexamethasone followed by 700 µg Dexamethasone - 350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Sham Comparator: Sham Injection followed by 700 µg Dexamethasone - Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Treatment: Drugs: 700 µg Dexamethasone
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
Treatment: Drugs: 350 µg Dexamethasone
350 µg Dexamethasone intravitreal implant administered on Day 0.
Other interventions: Sham Injection
Sham injection on Day 0.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
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Assessment method [1]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.
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Timepoint [1]
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Day 180
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Secondary outcome [1]
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Change From Baseline in Retinal Thickness in the Study Eye
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Assessment method [1]
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Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
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Timepoint [1]
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Baseline, Day 90, Day 180
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Secondary outcome [2]
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Percentage of Patients With a Change From Baseline in BCVA by Category
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Assessment method [2]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: =15 Letters Improvement, =5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), =5 and <15 Letters Worsening, and =15 Letters Worsening.
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Timepoint [2]
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Baseline, Day 90
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Secondary outcome [3]
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Percentage of Patients With a Change From Baseline in BCVA by Category
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Assessment method [3]
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BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: =15 Letters Improvement, =5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), =5 and <15 Letters Worsening, and =15 Letters Worsening.
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Timepoint [3]
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Baseline, Day 180
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Eligibility
Key inclusion criteria
Key
- 18 years of age or older with macular edema resulting from retinal vein occlusion
- Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or
worse)
- Visual acuity in other eye no worse than 20/200
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Known anticipated need for ocular surgery within next 12 months
- History of glaucoma or current high eye pressure requiring more than 1 medication
- Diabetic retinopathy
- Uncontrolled systemic disease
- Known steroid-responder
- Use of systemic steroids
- Use of warfarin/heparin
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/09/2008
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Sample size
Target
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Accrual to date
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Final
668
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Texas
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Country [2]
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Brazil
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State/province [2]
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Sao Paulo
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Canada
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Ontario
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Colombia
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Bogota
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Country [5]
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Hong Kong
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State/province [5]
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Kowloon
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Country [6]
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India
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State/province [6]
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Tamil Nadu
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Country [7]
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Italy
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State/province [7]
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Udine
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Country [8]
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Korea, Republic of
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State/province [8]
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Seoul
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Country [9]
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New Zealand
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State/province [9]
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Auckland
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Country [10]
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Poland
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State/province [10]
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Poznan
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Singapore
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State/province [11]
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Singapore
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Country [12]
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Spain
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State/province [12]
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Alicante
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Country [13]
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United Kingdom
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State/province [13]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone
for the treatment of macular edema associated with retinal vein occlusion.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00168298
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Trial related presentations / publications
Haller JA, Bandello F, Belfort R Jr, Blumenkranz MS, Gillies M, Heier J, Loewenstein A, Yoon YH, Jacques ML, Jiao J, Li XY, Whitcup SM; OZURDEX GENEVA Study Group. Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion. Ophthalmology. 2010 Jun;117(6):1134-1146.e3. doi: 10.1016/j.ophtha.2010.03.032. Epub 2010 Apr 24.
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00168298
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