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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Scientific title
Secondary ID [1] 0 0
208397-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular Edema 0 0
Retinal Vein Occlusion 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
Timepoint [1] 0 0
Baseline, Month 1
Primary outcome [2] 0 0
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
Timepoint [2] 0 0
Baseline, Month 1
Primary outcome [3] 0 0
Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
Timepoint [3] 0 0
Baseline, Month 1
Primary outcome [4] 0 0
Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
Timepoint [4] 0 0
Baseline, Month 1
Secondary outcome [1] 0 0
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
Timepoint [1] 0 0
Baseline, Month 12
Secondary outcome [2] 0 0
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
Timepoint [2] 0 0
Baseline, Month 12
Secondary outcome [3] 0 0
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
Timepoint [3] 0 0
Baseline, Month 12
Secondary outcome [4] 0 0
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
Timepoint [4] 0 0
Baseline, Month 12

Eligibility
Key inclusion criteria
* macular edema due to retinal vein occlusion
* visual acuity in the study eye between 20/320 to 20/40
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2013
Sample size
Target
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- East Melbourne
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Israel
State/province [3] 0 0
Tel Aviv
Country [4] 0 0
South Africa
State/province [4] 0 0
Cape Town

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01027650
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01027650