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

This study has been terminated.
(The study was terminated early due to company decision (non-safety related).)
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00395057
First received: October 31, 2006
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Choroid Neovascularization
Age-Related Macular Degeneration
Drug: AGN 211745
Drug: AGN 211745
Drug: Ranibizumab 500µg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred.


Enrollment: 138
Study Start Date: January 2007
Study Completion Date: February 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395057

Locations
United States, Texas
Houston, Texas, United States
Australia, New South Wales
Sydney, New South Wales, Australia
Philippines
Makati, Philippines
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00395057     History of Changes
Other Study ID Numbers: 211745-001
Study First Received: October 31, 2006
Results First Received: November 9, 2011
Last Updated: November 9, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on April 17, 2014