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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Choroid Neovascularization Age-Related Macular Degeneration Drug: AGN 211745 Drug: Ranibizumab 500µg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: AGN 211745 Solution 1000 ug
AGN 211745 Solution 1000 ug
 Drug: AGN 211745
AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2
Other Name: Sirna-027
Experimental: AGN 211745 Solution 300 ug
AGN 211745 Solution 300 ug
 Drug: AGN 211745
AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2
Other Name: Sirna-027
Experimental: AGN 211745 Solution 100 ug
AGN 211745 Solution 100 ug
 Drug: AGN 211745
AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2
Other Name: Sirna-027
Active Comparator: Ranibizumab 500 ug
Ranibizumab 500 ug
 Drug: Ranibizumab 500µg
Ranibizumab 500µg injections at Day 1, Month 1, Month 2
Other Name: Lucentis®


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395057


Locations
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United States, Texas
Houston, Texas, United States
Australia, New South Wales
Sydney, New South Wales, Australia
Philippines
Makati, Philippines
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00395057    
Other Study ID Numbers: 211745-001
First Posted: November 2, 2006    Key Record Dates
Results First Posted: December 13, 2011
Last Update Posted: September 7, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
 Uveal Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents