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

Phase 2TerminatedNCT00395057

Allergan138 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

138

Conditions

Choroid Neovascularization Age-Related Macular Degeneration

Interventions

AGN 211745DRUG

AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2

AGN 211745DRUG

AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2

AGN 211745DRUG

AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Houston, Texas, United States

Unnamed facility

Sydney, New South Wales, Australia

Unnamed facility

Makati, Philippines

Outcomes

Primary Outcomes

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.

Time frame: Month 3

Secondary Outcomes

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.

Time frame: Month 3

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.

Time frame: Month 3

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.

Time frame: Month 3

Data from ClinicalTrials.gov

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