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

Age-Related Macular Degeneration Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00395057
• Other study ID #: 211745-001
• Status: Terminated
• Phase: Phase 2
• First received: October 31, 2006
• Last updated: August 25, 2015
• Start date: January 2007
• Est. completion date: February 2009

Study information

• Verified date: August 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 138
• Est. completion date: February 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroid Neovascularization
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• AGN 211745
AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2
• AGN 211745
AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2
• AGN 211745
AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2
• Ranibizumab 500µg
Ranibizumab 500µg injections at Day 1, Month 1, Month 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 3	No
Secondary	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.	Month 3	No
Secondary	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.	Month 3	No
Secondary	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.	Month 3	No
Secondary	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.	Month 6	No