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
sites
Colorado Springs, Colorado 80907
1065
mi
from 98109
Colorado Springs, CO
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Atlanta, Georgia 30322
2179
mi
from 98109
Atlanta, GA
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Beverly Hills, California 90211
959
mi
from 98109
Beverly Hills, CA
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Boston, Massachusetts 02118
2485
mi
from 98109
Boston, MA
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Charlotte, North Carolina 28277
2289
mi
from 98109
Charlotte, NC
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Cincinnati, Ohio 45229
1966
mi
from 98109
Cincinnati, OH
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Cleveland, Ohio 44109
2021
mi
from 98109
Cleveland, OH
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Fort Myers, Florida 33912
2622
mi
from 98109
Fort Myers, FL
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Grand Rapids, Michigan 49503
1794
mi
from 98109
Grand Rapids, MI
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Jackson, Michigan 49202
1872
mi
from 98109
Jackson, MI
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Leawood, Kansas 66211
1506
mi
from 98109
Leawood, KS
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Miami, Florida 33136
2730
mi
from 98109
Miami, FL
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Pasadena, California 91105
957
mi
from 98109
Pasadena, CA
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Phoenix, Arizona 85012
1112
mi
from 98109
Phoenix, AZ
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Phoenix, Arizona 85012
1112
mi
from 98109
Phoenix, AZ
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Sacramento, California 95825
626
mi
from 98109
Sacramento, CA
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Silverdale, Washington 98383
16
mi
from 98109
Silverdale, WA
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Tucson, Arizona 85745
1214
mi
from 98109
Tucson, AZ
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Winter Haven, Florida 33880
2555
mi
from 98109
Winter Haven, FL
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