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

August 25, 2015 updated by: Allergan
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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AGN 211745 Solution 1000 ug
Drug: AGN 211745
AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2
Other Names:
  • Sirna-027
Drug: AGN 211745
AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2
Other Names:
  • Sirna-027
Drug: AGN 211745
AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2
Other Names:
  • Sirna-027
Experimental: AGN 211745 Solution 300 ug
Drug: AGN 211745
AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2
Other Names:
  • Sirna-027
Drug: AGN 211745
AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2
Other Names:
  • Sirna-027
Drug: AGN 211745
AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2
Other Names:
  • Sirna-027
Experimental: AGN 211745 Solution 100 ug
Drug: AGN 211745
AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2
Other Names:
  • Sirna-027
Drug: AGN 211745
AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2
Other Names:
  • Sirna-027
Drug: AGN 211745
AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2
Other Names:
  • Sirna-027
Active Comparator: Ranibizumab 500 ug
Drug: Ranibizumab 500µg
Ranibizumab 500µg injections at Day 1, Month 1, Month 2
Other Names:
  • Lucentis®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 3
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.
Month 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.
Month 3
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.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 31, 2006

First Submitted That Met QC Criteria

October 31, 2006

First Posted (Estimate)

November 2, 2006

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211745-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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