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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00799227
Registration number
NCT00799227
Ethics application status
Date submitted
26/11/2008
Date registered
27/11/2008
Date last updated
23/04/2019
Titles & IDs
Public title
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
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Scientific title
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Secondary ID [1]
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206207-018
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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:
Diabetic Macular Edema
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Vitrectomy
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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 - Dexamethasone
Experimental: 700 µg Dexamethasone Implant - 700 µg dexamethasone implant in the study eye at Day 1
Treatment: Drugs: Dexamethasone
700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.
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Intervention code [1]
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Treatment: Drugs
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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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Change From Baseline in Central Retinal Thickness in the Study Eye
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Assessment method [1]
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Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.
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Timepoint [1]
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Baseline, Week 26
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Secondary outcome [1]
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Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
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Assessment method [1]
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BCVA is measured in the study eye 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 from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.
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Timepoint [1]
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Baseline, Week 26
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Secondary outcome [2]
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Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye
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Assessment method [2]
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BCVA is measured in the study eye 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
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Timepoint [2]
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Baseline, Week 26
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Secondary outcome [3]
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Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye
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Assessment method [3]
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Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased = 10%), Unchanged (leakage area changed \< 10%), and Worsened (leakage area increased = 10%).
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Timepoint [3]
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Baseline, Week 26
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Eligibility
Key inclusion criteria
* 18 years of age or older with diabetic macular edema
* History of vitrectomy
* Central retinal thickness = 275 µm
* Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye
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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 during the study period
* History of glaucoma or current high eye pressure requiring more than 1 medication
* Uncontrolled systemic disease
* Known allergy to the study medication
* Known steroid-responder
* Use of systemic steroids
* Female subjects that are pregnant, nursing or planning a pregnancy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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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
1/01/2009
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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
1/12/2009
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Sample size
Target
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Accrual to date
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Final
56
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Sydney
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Recruitment postcode(s) [1]
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- Sydney
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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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North Carolina
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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
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.
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Trial website
https://clinicaltrials.gov/study/NCT00799227
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Trial related presentations / publications
Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23. doi: 10.1097/IAE.0b013e318206d18c.
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00799227
Download to PDF