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

Phase 2

Terminated

• Conditions: Choroid Neovascularization; Age-Related Macular Degeneration
• Interventions: Drug: AGN 211745; Drug: Ranibizumab 500µg

• Registration Number: NCT00395057
• Lead Sponsor: Allergan

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 available

Study Timeline

• Study First Submitted: 2006-10-31
• Study First Submitted QC: 2006-10-31
• Study First Posted: 2006-11-02
• Study Start: 2007-01
• Primary Completion: 2008-10
• Study Completion: 2009-02
• Results First Submitted: 2011-11-09
• Results First Submitted QC: 2011-11-09
• Results First Posted: 2011-12-13
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-25
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGN 211745 Solution 300 ug	AGN 211745	AGN 211745 Solution 300 ug
Ranibizumab 500 ug	Ranibizumab 500µg	Ranibizumab 500 ug
AGN 211745 Solution 1000 ug	AGN 211745	AGN 211745 Solution 1000 ug
AGN 211745 Solution 100 ug	AGN 211745	AGN 211745 Solution 100 ug

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3	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

Name	Time	Method
Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3	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	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.
Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3	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.
Time to Treatment With Standard of Care at Month 6	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.