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A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00395057
Recruitment Status : Terminated (The study was terminated early due to company decision (non-safety related).)
First Posted : November 2, 2006
Results First Posted : December 13, 2011
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE October 31, 2006
First Posted Date  ICMJE November 2, 2006
Results First Submitted Date  ICMJE November 9, 2011
Results First Posted Date  ICMJE December 13, 2011
Last Update Posted Date September 7, 2015
Study Start Date  ICMJE January 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2011)
Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
Visual Acuity
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2011)
  • Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
  • Lesion size
  • Foveal thickness
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
Official Title  ICMJE Not Provided
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Choroid Neovascularization
  • Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: AGN 211745
    AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2
    Other Name: Sirna-027
  • Drug: AGN 211745
    AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2
    Other Name: Sirna-027
  • Drug: AGN 211745
    AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2
    Other Name: Sirna-027
  • Drug: Ranibizumab 500µg
    Ranibizumab 500µg injections at Day 1, Month 1, Month 2
    Other Name: Lucentis®
Study Arms  ICMJE
  • Experimental: AGN 211745 Solution 1000 ug
    AGN 211745 Solution 1000 ug
    Intervention: Drug: AGN 211745
  • Experimental: AGN 211745 Solution 300 ug
    AGN 211745 Solution 300 ug
    Intervention: Drug: AGN 211745
  • Experimental: AGN 211745 Solution 100 ug
    AGN 211745 Solution 100 ug
    Intervention: Drug: AGN 211745
  • Active Comparator: Ranibizumab 500 ug
    Ranibizumab 500 ug
    Intervention: Drug: Ranibizumab 500µg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 7, 2009)
138
Original Enrollment  ICMJE
 (submitted: October 31, 2006)
135
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Philippines,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00395057
Other Study ID Numbers  ICMJE 211745-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP