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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00395057




Registration number
NCT00395057
Ethics application status
Date submitted
31/10/2006
Date registered
2/11/2006
Date last updated
7/09/2015

Titles & IDs
Public title
A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
Scientific title
Secondary ID [1] 0 0
211745-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Choroid Neovascularization 0 0
Age-Related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AGN 211745
Treatment: Drugs - AGN 211745
Treatment: Drugs - AGN 211745
Treatment: Drugs - Ranibizumab 500µg

Experimental: AGN 211745 Solution 1000 ug - AGN 211745 Solution 1000 ug

Experimental: AGN 211745 Solution 300 ug - AGN 211745 Solution 300 ug

Experimental: AGN 211745 Solution 100 ug - AGN 211745 Solution 100 ug

Active comparator: Ranibizumab 500 ug - Ranibizumab 500 ug


Treatment: Drugs: AGN 211745
AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2

Treatment: Drugs: AGN 211745
AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2

Treatment: Drugs: AGN 211745
AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2

Treatment: Drugs: Ranibizumab 500µg
Ranibizumab 500µg injections at Day 1, Month 1, Month 2
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3
Timepoint [1] 0 0
Month 3
Secondary outcome [1] 0 0
Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3
Timepoint [1] 0 0
Month 3
Secondary outcome [2] 0 0
Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3
Timepoint [2] 0 0
Month 3
Secondary outcome [3] 0 0
Visual Functioning Questionnaire (VFQ) at Month 3
Timepoint [3] 0 0
Month 3
Secondary outcome [4] 0 0
Time to Treatment With Standard of Care at Month 6
Timepoint [4] 0 0
Month 6

Eligibility
Key inclusion criteria
* 50 years or older with "wet" AMD as determined by an ophthalmologist
* decrease in visual acuity (20/40 to 20/640) in at least one eye
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Uncontrolled systemic disease
* History of heart attack or stroke within one year of study entry
* Symptomatic coronary artery disease
* Cataracts that interfere with vision

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2009
Sample size
Target
Accrual to date
Final
138
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Philippines
State/province [2] 0 0
Makati

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT00395057