Trial Condition(s):

Macular degeneration

Managing neovascular (known as "wet") age-related macular degeneration over 2 years using different treatment schedules of 2 mg intravitreal aflibercept injected in the eye (ARIES)

Bayer Identifier:

17508

ClinicalTrials.gov Identifier:

NCT02581891

EudraCT Number:

2014-003132-39

Study Completed

Trial Purpose

This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.

Inclusion Criteria
-  Men and women ≥ 50 years of age.
 -  Active primary subfoveal CNV lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.  Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the eCRF.
 -  ETDRS BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye.
 -  The area of CNV must occupy at least 50% of the total lesion.
Exclusion Criteria
-  Any prior ocular (in the study eye) or systemic treatment or surgery for nAMD, except dietary supplements or vitamins.
 -  Any prior or concomitant therapy with another investigational agent to treat nAMD in the study eye.
 -  Prior treatment with anti-VEGF agents as follows:
 -  Prior treatment with anti-VEGF therapy in the study eye is not allowed
 -  Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not approved, e.g. bevacizumab) within the last 3 months before the first dose in the study.  Such treatment will also not be allowed during the study.  Prior treatment with an approved anti-VEGF therapy in the fellow eye is allowed.
 -  Prior systemic anti-VEGF therapy, investigational or approved, within the last 3 months before the first dose in the study, and such treatment will not be allowed during the study.
 -  Total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
 -  Subretinal hemorrhages that are either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye.  (If the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
 -  Scar or fibrosis making up >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.

Trial Summary

Enrollment Goal
287
Trial Dates
black-arrow
Phase
4
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

Ottawa, Canada, K2B 7E9

Status
Completed
 
Locations

Investigative Site

Boisbriand, Canada, J7H 1S6

Status
Completed
 
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Investigative Site

Padova, Italy, 35128

Status
Completed
 
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Investigative Site

Roma, Italy, 00198

Status
Completed
 
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Investigative Site

Milano, Italy, 20132

Status
Completed
 
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Investigative Site

Milano, Italy, 20157

Status
Completed
 
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Investigative Site

Hannover, Germany, 30625

Status
Completed
 
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Investigative Site

Köln, Germany, 50924

Status
Completed
 
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Investigative Site

Tübingen, Germany, 72076

Status
Completed
 
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Investigative Site

Freiburg, Germany, 79106

Status
Completed
 
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Investigative Site

Sulzbach, Germany, 66280

Status
Completed
 
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Investigative Site

Bonn, Germany, 53105

Status
Completed
 
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Investigative Site

Oviedo, Spain, 33012

Status
Completed
 
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Investigative Site

Zaragoza, Spain, 50009

Status
Completed
 
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Investigative Site

Madrid, Spain

Status
Completed
 
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Investigative Site

Westmead, Australia, 2145

Status
Completed
 
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Investigative Site

Sydney, Australia, 2000

Status
Completed
 
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Investigative Site

East Melbourne, Australia, 3002

Status
Completed
 
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Investigative Site

Liverpool, United Kingdom, L7 8XP

Status
Completed
 
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Investigative Site

Bristol, United Kingdom, BS1 2LX

Status
Completed
 
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Investigative Site

London, United Kingdom, EC1V 2PD

Status
Completed
 
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Investigative Site

Oxford, United Kingdom, OX3 9DU

Status
Completed
 
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Investigative Site

Launceston, Australia, 7249

Status
Completed
 
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Investigative Site

CRETEIL CEDEX, France, 94010

Status
Completed
 
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Investigative Site

Nice cedex 1, France, 06006

Status
Completed
 
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Investigative Site

Canterbury, United Kingdom, CT1 3NG

Status
Completed
 
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Investigative Site

Chemnitz, Germany, 09116

Status
Completed
 
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Investigative Site

Hamilton, Canada, L8G 5E4

Status
Completed
 
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Investigative Site

Berlin, Germany, 10713

Status
Completed
 
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Investigative Site

Strathfield, Australia, 2135

Status
Completed
 
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Investigative Site

Pecs, Hungary, 7621

Status
Completed
 
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Investigative Site

Budapest, Hungary, 1085

Status
Completed
 
Locations

Investigative Site

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1133

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1106

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1115

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1062

Status
Completed
 
Locations

Investigative Site

Szombathely, Hungary, 9700

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1125

Status
Completed
 

Trial Design