Back to resultsA Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
Primary Purpose
Choroid Neovascularization, Age-Related Macular Degeneration
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AGN 211745
AGN 211745
AGN 211745
Ranibizumab 500µg
Sponsored by
About this trial
This is an interventional treatment trial for Choroid Neovascularization
Eligibility Criteria
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
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
AGN 211745 Solution 1000 ug
AGN 211745 Solution 300 ug
AGN 211745 Solution 100 ug
Ranibizumab 500 ug
Arm Description
AGN 211745 Solution 1000 ug
AGN 211745 Solution 300 ug
AGN 211745 Solution 100 ug
Ranibizumab 500 ug
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00395057
Brief Title
A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early due to company decision (non-safety related).
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroid Neovascularization, Age-Related Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AGN 211745 Solution 1000 ug
Arm Type
Experimental
Arm Description
AGN 211745 Solution 1000 ug
Arm Title
AGN 211745 Solution 300 ug
Arm Type
Experimental
Arm Description
AGN 211745 Solution 300 ug
Arm Title
AGN 211745 Solution 100 ug
Arm Type
Experimental
Arm Description
AGN 211745 Solution 100 ug
Arm Title
Ranibizumab 500 ug
Arm Type
Active Comparator
Arm Description
Ranibizumab 500 ug
Intervention Type
Drug
Intervention Name(s)
AGN 211745
Other Intervention Name(s)
Sirna-027
Intervention Description
AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2
Intervention Type
Drug
Intervention Name(s)
AGN 211745
Other Intervention Name(s)
Sirna-027
Intervention Description
AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2
Intervention Type
Drug
Intervention Name(s)
AGN 211745
Other Intervention Name(s)
Sirna-027
Intervention Description
AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 500µg
Other Intervention Name(s)
Lucentis®
Intervention Description
Ranibizumab 500µg injections at Day 1, Month 1, Month 2
Primary Outcome Measure Information:
Title
Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3
Description
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.
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3
Description
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.
Time Frame
Month 3
Title
Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3
Description
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.
Time Frame
Month 3
Title
Visual Functioning Questionnaire (VFQ) at Month 3
Description
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.
Time Frame
Month 3
Title
Time to Treatment With Standard of Care at Month 6
Description
Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred.
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Houston
State/Province
Texas
Country
United States
City
Sydney
State/Province
New South Wales
Country
Australia
City
Makati
Country
Philippines
12. IPD Sharing Statement
Learn more about this trial
A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
We'll reach out to this number within 24 hrs