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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/NCT01027650
Registration number
NCT01027650
Ethics application status
Date submitted
4/12/2009
Date registered
8/12/2009
Date last updated
29/04/2014
Titles & IDs
Public title
Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)
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Scientific title
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Secondary ID [1]
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208397-001
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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 - AGN208397 intravitreal injection
Treatment: Drugs - dexamethasone intravitreal implant
Experimental: Stage 1 Cohort 1 - AGN208397 intravitreal injection 75 ug on Day 1.
Experimental: Stage 1 Cohort 2 - AGN208397 intravitreal injection 300 ug on Day 1.
Experimental: Stage 1 Cohort 3 - AGN208397 intravitreal injection 600 ug on Day 1.
Experimental: Stage 1 Cohort 4 - AGN208397 intravitreal injection 900 ug on Day 1.
Experimental: Stage 2 Arm 1 - AGN208397 intravitreal injection 600 ug on Day 1.
Experimental: Stage 2 Arm 2 - AGN208397 intravitreal injection 450 ug on Day 1.
Experimental: Stage 2 Arm 3 - AGN208397 intravitreal injection 300 ug on Day 1.
Active Comparator: Stage 2 Arm 4 - Dexamethasone 700 ug intravitreal implant on Day 1.
Treatment: Drugs: AGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
Treatment: Drugs: dexamethasone intravitreal implant
Dexamethasone 700 ug intravitreal implant on Day 1.
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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 at Month 1 in Retinal Thickness in the Study Eye During Stage 1
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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, Month 1
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Primary outcome [2]
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Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
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Assessment method [2]
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Retinal thickness is assessed by 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 [2]
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Baseline, Month 1
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Primary outcome [3]
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Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
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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.
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Timepoint [3]
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Baseline, Month 1
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Primary outcome [4]
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Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Month 1
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Secondary outcome [1]
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Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
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Assessment method [1]
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Retinal thickness is assessed by 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, Month 12
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Secondary outcome [2]
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Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
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Assessment method [2]
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Retinal thickness is assessed by 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 [2]
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Baseline, Month 12
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Secondary outcome [3]
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Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
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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.
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Timepoint [3]
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Baseline, Month 12
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Secondary outcome [4]
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Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Month 12
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Eligibility
Key inclusion criteria
- macular edema due to retinal vein occlusion
- visual acuity in the study eye between 20/320 to 20/40
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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
- cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for
cataract surgery during study period (12 months)
- use of injectable drugs in the study eye within 2 months prior to day 1
- active eye infection in either eye
- visual acuity in the non-study eye of 20/200 or worse
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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 assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/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
1/03/2010
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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
1/02/2013
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Sample size
Target
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Accrual to date
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Final
121
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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- East Melbourne
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Recruitment postcode(s) [1]
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- East Melbourne
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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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Arizona
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Country [2]
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Canada
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State/province [2]
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Ontario
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Country [3]
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Israel
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State/province [3]
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Tel Aviv
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Country [4]
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South Africa
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State/province [4]
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Cape Town
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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 a single intravitreal injection of
AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being
conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a
single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of
AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2
will enroll approximately 96 subjects who will receive a single masked intravitreal injection
of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01027650
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Trial related presentations / publications
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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/NCT01027650
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