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Trial details imported from ClinicalTrials.gov

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




Trial ID
NCT00395057
Ethics application status
Date submitted
31/10/2006
Date registered
31/10/2006
Date last updated
25/08/2015

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
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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 - Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. 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.
Timepoint [1] 0 0
Month 3
Secondary outcome [1] 0 0
Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3 - Lesion size as assessed by FA and photography at month 3. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc.
Timepoint [1] 0 0
Month 3
Secondary outcome [2] 0 0
Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3 - Foveal thickness as assessed by OCT at month 3. The fovea is a part of the eye, located in the center of the macula region of the retina. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. The fovea is responsible for sharp central vision, which is necessary for reading or any activity where visual detail is of primary importance. Normal foveal thickness ranges from 175 to 250 microns. A foveal thickness greater than 250 microns represents worsening vision.
Timepoint [2] 0 0
Month 3
Secondary outcome [3] 0 0
Visual Functioning Questionnaire (VFQ) at Month 3 - Visual Functioning Questionnaire (VFQ) at Month 3. The VFQ includes 25 questions which assess visual impairment on functioning and specific aspects of health-related quality of life. Study terminated; data for this outcome measure were not analyzed.
Timepoint [3] 0 0
Month 3
Secondary outcome [4] 0 0
Time to Treatment With Standard of Care at Month 6 - Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred.
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
Gender
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as
Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related
macular degeneration
Trial website
https://clinicaltrials.gov/show/NCT00395057
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