Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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