Trial Condition(s):

Macular degeneration

Efficacy and safety of two different aflibercept regimens in subjects with neovascular age-related macular degeneration (nAMD)

Bayer Identifier:

16598

ClinicalTrials.gov Identifier:

NCT02540954

EudraCT Number:

2013-000120-33

Study Completed

Trial Purpose

To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)

Inclusion Criteria
-  The following criteria must have been met at the initial start of aflibercept treatment (i.e. start of aflibercept treatment at least 1 year before this study):
 -- Subject had primary subfoveal choroidal neovascularization (CNV) lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea, as evidenced by fluorescein angiography/photography (FA/FP) of the study eye within 3 weeks before the initiation of aflibercept treatment.
 -- The area of CNV occupied at least 50% of the total lesion within 3 weeks before the initiation of aflibercept treatment.
 -- Documented best-corrected visual acuity (BCVA) was 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment.
 - Men and women >= 51 years of age
 - The subject’s history of aflibercept treatment meets ALL of the following:
 --  Treatment in the study eye was initiated with three monthly (-1 week/+2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed
 -- Following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks
Exclusion Criteria
- Any prior or concomitant therapy with an investigational or approved agent to treat neovascular AMD in the study eye other than aflibercept.
 -- Total lesion size > 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by fluorescein angiography (FA) in the study eye
 -- Subretinal hemorrhage that was:
a) 50% or more of the total lesion area, or
b) if the blood was under the fovea, and
c) the blood under the fovea was 1 or more disc areas in size in the study eye.
 -- Scar or fibrosis making up more than 50% of the total lesion in the study eye.
 -- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
 -- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
 -- Causes of CNV other than AMD in the study eye.

Trial Summary

Enrollment Goal
336
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Darmstadt, Germany, 64297

Status
Completed
 
Locations

Investigative Site

Göttingen, Germany, 37075

Status
Completed
 
Locations

Investigative Site

Frankfurt, Germany, 60596

Status
Completed
 
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Investigative Site

Hamburg, Germany, 20251

Status
Completed
 
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Investigative Site

Leipzig, Germany, 04103

Status
Completed
 
Locations

Investigative Site

Marburg, Germany, 35037

Status
Completed
 
Locations

Investigative Site

Dijon Cedex, France, BP 1542-21

Status
Completed
 
Locations

Investigative Site

BORDEAUX, France, 33000

Status
Completed
 
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Investigative Site

Paris, France, 75557

Status
Completed
 
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Investigative Site

LYON CEDEX 04, France, 69317

Status
Completed
 
Locations

Investigative Site

NICE CEDEX, France, 06006

Status
Completed
 
Locations

Clinique medicale de l'oeil de l'Estrie

Sherbrooke, Canada, J1J 2B8

Status
Recruiting
 
Locations

Investigative Site

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

Investigative Site

Praha 10, Czech Republic, 100 34

Status
Completed
 
Locations

Investigative Site

Hradec Kralove, Czech Republic, 500 05

Status
Completed
 
Locations

Investigative Site

Wien, Austria, 1140

Status
Not yet recruiting
 
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Investigative Site

Wien, Austria, 1090

Status
Completed
 
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Investigative Site

Berlin, Germany, 12203

Status
Completed
 
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Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
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Investigative Site

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
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Investigative Site

Valencia, Spain, 46014

Status
Completed
 
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Investigative Site

Budapest, Hungary, 1085

Status
Completed
 
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Investigative Site

Debrecen, Hungary, 4032

Status
Completed
 
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Investigative Site

Pecs, Hungary, 7621

Status
Completed
 
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Investigative Site

Bratislava, Slovakia, 851 07

Status
Completed
 
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Investigative Site

Nitra, Slovakia, 949 01

Status
Completed
 
Locations

Investigative Site

Bratislava, Slovakia, 826 06

Status
Completed
 
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Investigative Site

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
Locations

Investigative Site

Guildford, United Kingdom, GU2 7XX

Status
Completed
 
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Investigative Site

Sunderland, United Kingdom, SR2 9HP

Status
Completed
 
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Investigative Site

London, United Kingdom, SE5 9RS

Status
Completed
 
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Investigative Site

Newcastle Upon Tyne, United Kingdom, NE1 4LP

Status
Completed
 
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Investigative Site

London, United Kingdom, NW1 5QH

Status
Completed
 
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Investigative Site

Manchester, United Kingdom, M13 9WL

Status
Completed
 
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Investigative Site

Gdansk, Poland, 80-809

Status
Completed
 
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Investigative Site

Genova, Italy, 16132

Status
Completed
 
Locations

Investigative Site

Torino, Italy, 10122

Status
Completed
 
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Investigative Site

Roma, Italy, 00133

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20122

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20132

Status
Completed
 
Locations

Investigative Site

Verona, Italy, 37134

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20157

Status
Completed
 
Locations

Investigative Site

Roma, Italy, 00198

Status
Completed
 
Locations

Investigative Site

Porto, Portugal, 4200-319

Status
Completed
 
Locations

Investigative Site

Leiria, Portugal, 2410-197

Status
Completed
 
Locations

Investigative Site

Lisboa, Portugal, 1649-035

Status
Completed
 
Locations

Investigative Site

Coimbra, Portugal, 3000-548

Status
Completed
 
Locations

Investigative Site

Kaunas, Lithuania, LT-50009

Status
Completed
 
Locations

Investigative Site

Vilnius, Lithuania, LT-08661

Status
Recruiting
 
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Investigative Site

Bern, Switzerland

Status
Completed
 
Locations

Investigative Site

Genève, Switzerland, 1204

Status
Recruiting
 
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Investigative Site

Olsztyn, Poland, 10-424

Status
Completed
 
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Investigative Site

Colchester, United Kingdom, CO3 3NB

Status
Completed
 
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Investigative Site

Würzburg, Germany, 97080

Status
Completed
 
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Investigative Site

Paris, France, 75010

Status
Completed
 
Locations

Investigative Site

Liverpool, United Kingdom, L7 8XP

Status
Completed
 
Locations

Investigative Site

Praha 2, Czech Republic, 12808

Status
Completed
 
Locations

Investigative Site

Plzen, Czech Republic, 304 60

Status
Completed
 
Locations

Investigative Site

Praha 5, Czech Republic, 150 00

Status
Completed
 
Locations

Investigative Site

Pisa, Italy, 56124

Status
Completed
 
Locations

Investigative Site

Brescia, Italy, 25015

Status
Completed
 
Locations

Investigative Site

Parma, Italy, 43126

Status
Not yet recruiting
 
Locations

Investigative Site

Berlin, Germany, 10713

Status
Completed
 
Locations

Investigative Site

Catania, Italy, 95123

Status
Completed
 
Locations

Investigative Site

Düsseldorf, Germany, 40225

Status
Completed
 
Locations

Investigative Site

Wakefield, United Kingdom, WF1 4DG

Status
Completed
 
Locations

Investigative Site

Great Yarmouth, United Kingdom, NR31 6LA

Status
Completed
 
Locations

Investigative Site

Hull, United Kingdom, HU3 2JZ

Status
Completed
 
Locations

Investigative Site

Middlesborough, United Kingdom, TS4 3BW

Status
Completed
 
Locations

Investigative Site

Pontyclun, United Kingdom, CF72 8XR

Status
Completed
 
Locations

Investigative Site

Rugby, United Kingdom, CV22 5PX

Status
Completed
 

Trial Design