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

Allergan

Status and phase: Terminated; Phase 2

Conditions: Age-Related Macular Degeneration; Choroid Neovascularization

Treatments: Drug: AGN 211745; Drug: Ranibizumab 500µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395057

211745-001

Details and patient eligibility

About

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

Enrollment: 138 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 4 patient groups

AGN 211745 Solution 1000 ug

Experimental group

Description:

AGN 211745 Solution 1000 ug

Treatment:

Drug: AGN 211745

Drug: AGN 211745

Drug: AGN 211745

AGN 211745 Solution 300 ug

Experimental group

Description:

AGN 211745 Solution 300 ug

Treatment:

Drug: AGN 211745

Drug: AGN 211745

Drug: AGN 211745

AGN 211745 Solution 100 ug

Experimental group

Description:

AGN 211745 Solution 100 ug

Treatment:

Drug: AGN 211745

Drug: AGN 211745

Drug: AGN 211745

Ranibizumab 500 ug

Active Comparator group

Description:

Ranibizumab 500 ug

Treatment:

Drug: Ranibizumab 500µg