check_circleStudy Completed

Macular degeneration

Bayer Identifier:

17508

ClinicalTrials.gov Identifier:

NCT02581891

EudraCT Number:

2014-003132-39

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

Both

Age

50 - N/A
  • - 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.

  • - 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
November 2015 - April 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Ottawa, K2B7E9, Canada
Completed
Boisbriand, J7H1S6, Canada
Withdrawn
Toronto, M5C 2T2, Canada
Completed
Padova, 35128, Italy
Completed
Roma, 00198, Italy
Completed
Milano, 20132, Italy
Completed
Milano, 20157, Italy
Completed
Hannover, 30625, Germany
Completed
Köln, 50924, Germany
Completed
Tübingen, 72076, Germany
Completed
Freiburg, 79106, Germany
Completed
Sulzbach, 66280, Germany
Completed
Bonn, 53105, Germany
Completed
Oviedo, 33012, Spain
Completed
Zaragoza, 50009, Spain
Completed
Madrid, Spain
Completed
Westmead, 2145, Australia
Completed
Sydney, 2000, Australia
Completed
East Melbourne, 3002, Australia
Completed
Liverpool, L7 8XP, United Kingdom
Completed
Bristol, BS12LX, United Kingdom
Completed
London, EC1V2PD, United Kingdom
Completed
Oxford, OX3 9DU, United Kingdom
Withdrawn
Belfast, BT12 6BA, United Kingdom
Completed
Launceston, 7249, Australia
Completed
CRETEIL CEDEX, 94010, France
Completed
Nice cedex 1, 06006, France
Withdrawn
Drummondville, J2C 2C4, Canada
Withdrawn
NIJMEGEN, 6525 EX, Netherlands
Withdrawn
GRONINGEN, 9713 GZ, Netherlands
Withdrawn
Bolton, BL4 0JR, United Kingdom
Completed
Canterbury, CT1 3NG, United Kingdom
Completed
Chemnitz, 09116, Germany
Completed
Hamilton, L8G 5E4, Canada
Completed
Berlin, 10713, Germany
Completed
Strathfield, 2135, Australia
Completed
Pecs, 7621, Hungary
Completed
Budapest, 1085, Hungary
Completed
Debrecen, 4032, Hungary
Completed
Budapest, 1133, Hungary
Completed
Budapest, 1106, Hungary
Completed
Budapest, 1115, Hungary
Completed
Budapest, 1062, Hungary
Completed
Szombathely, 9700, Hungary
Completed
Budapest, 1125, Hungary

Primary Outcome

  • Change in best corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
    date_rangeTime Frame:
    Week 104
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Proportion of subjects maintaining vision (<3 lines loss)
    date_rangeTime Frame:
    Weeks 52 and 104
    enhanced_encryption
    Safety Issue:
    No
  • Change in BCVA as measured by the ETDRS letter score
    date_rangeTime Frame:
    Weeks 52 and 104
    enhanced_encryption
    Safety Issue:
    No
  • Change in central retinal thickness (CRT)
    date_rangeTime Frame:
    Weeks 52 and 104
    enhanced_encryption
    Safety Issue:
    No
  • Number of study drug injections
    date_rangeTime Frame:
    Weeks 52 and 104
    enhanced_encryption
    Safety Issue:
    No
  • Duration of last re-treatment interval
    date_rangeTime Frame:
    Week 104
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of subjects requiring retreatment at 8, 10, 12, 14, and 16 weeks as the last treatment interval
    date_rangeTime Frame:
    Week 104
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of 3-line vision gainers
    date_rangeTime Frame:
    Weeks 52 and 104
    enhanced_encryption
    Safety Issue:
    No

Trial design

Managing neovascular age-related macular degeneration (nAMD) over 2 years with a Treat and Extend (T&E) regimen of 2 mg intravitreal aflibercept - a randomized, open-label, active-controlled, parallel-group phase IV/IIIb study (ARIES)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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