Intravitreal LFG316 in Patients With Age-related Macular Degeneration (AMD)



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:55 - Any
Updated:7/29/2018
Start Date:January 25, 2012
End Date:June 24, 2015

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A Multicenter, Randomized, Sham-control, Proof-of-concept Study of Intravitreal LFG316 in Patients With Geographic Atrophy Associated With Age-related Macular Degeneration

This study was conducted in two parts; Part A and Part B: Part B was initially planned to
include two cohorts. Cohort 2 was cancelled following an interim analysis for efficacy in
Part A of the study, and not due to any safety issues or concerns. Cohort 2 is not referred
to again and part B cohort 1 is referred to as part B alone in the remainder of the document
and is the subject of this report.

Part B was conducted to assess the safety and tolerability of a single intravitreal (IVT)
LFG316 10 mg/100 µL injection. There was no efficacy evaluation in Part B. The study employed
a multicenter, randomized, sham - controlled, single masked design. Eight patients with
advanced AMD were planned to be randomized in a 3:1 ratio to receive a single IVT dose of
LFG316 (10 mg/100 µL) or sham injection. Patients assigned to a sham injection were treated
the same as those assigned to LFG316, except that the hub of an empty syringe (without
needle) was placed against the eye instead of the IVT injection.


Inclusion Criteria:

- Diagnosis of AMD if enrolled in Part B of study

- Geographic atrophy in at least one eye if enrolled in Part A of study

- ETDRS best corrected visual acuity of 60 letters or worse (~≤ 20/63)

Exclusion Criteria:

- Retinal disease other than AMD

- History of choroidal neovascularization

- Severe cataract

- History of infectious uveitis or endophthalmitis

- Eye surgery in the non-study eye within 30 days prior to study

- Eye surgery or IVT injection in the study eye within 90 days prior to study

- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
19
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Sacramento, California 95825
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Atlanta, Georgia 30322
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Beverly Hills, California 90211
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Boston, Massachusetts 02118
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Charlotte, North Carolina 28277
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Cincinnati, Ohio 45229
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Cleveland, Ohio 44109
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Colorado Springs, Colorado 80907
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Fort Myers, Florida 33912
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Grand Rapids, Michigan 49503
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Jackson, Michigan 49202
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Leawood, Kansas 66211
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Miami, Florida 33136
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Pasadena, California 91105
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Phoenix, Arizona 85012
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Phoenix, Arizona 85012
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Silverdale, Washington 98383
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Tucson, Arizona 85745
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Winter Haven, Florida 33880
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