A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Allergan
- Enrollment
- 138
- Primary Endpoint
- Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AGN 211745 Solution 1000 ug
AGN 211745 Solution 1000 ug
Intervention: AGN 211745 (Drug)
AGN 211745 Solution 300 ug
AGN 211745 Solution 300 ug
Intervention: AGN 211745 (Drug)
AGN 211745 Solution 100 ug
AGN 211745 Solution 100 ug
Intervention: AGN 211745 (Drug)
Ranibizumab 500 ug
Ranibizumab 500 ug
Intervention: Ranibizumab 500µg (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3(Month 3)
- Visual Functioning Questionnaire (VFQ) at Month 3(Month 3)
- Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3(Month 3)
- Time to Treatment With Standard of Care at Month 6(Month 6)