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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00395057
Date of registration:	31/10/2006
Prospective Registration:	Yes
Primary sponsor:	Allergan
Public title:	A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
Scientific title:
Date of first enrolment:	January 2007
Target sample size:	138
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT00395057
Study type:	Interventional
Study design:
Phase:	Phase 2

Countries of recruitment
Australia	Philippines	United States

Contacts

Name:	Medical Director
Address:
Telephone:
Email:
Affiliation:	Allergan

Key inclusion & exclusion criteria

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

Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Age-Related Macular Degeneration

Choroid Neovascularization

Intervention(s)

Drug: AGN 211745

Drug: Ranibizumab 500µg

Primary Outcome(s)

Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3 [Time Frame: Month 3]

Secondary Outcome(s)

Visual Functioning Questionnaire (VFQ) at Month 3 [Time Frame: Month 3]

Time to Treatment With Standard of Care at Month 6 [Time Frame: Month 6]

Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3 [Time Frame: Month 3]

Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3 [Time Frame: Month 3]

Secondary ID(s)

211745-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	13/12/2011
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00395057

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