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Trial record 1 of 1 for:    ARIES BAYER
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02581891
Recruitment Status : Completed
First Posted : October 21, 2015
Results First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321) Phase 4

Detailed Description:

The T&E dosing regimen for nAMD has emerged as a preferred regimen for many treating physicians aiming at maximizing outcomes by proactively treating the subject at each visit and by extending the treatment interval (if extension criteria are met), thus limiting visits, monitoring, and injections.

To this day, there is limited evidence available addressing the question of what are useful intervals for treating and monitoring, how do they differ among subjects, and how are retreatment criteria applied to achieve long-term desirable outcomes in real-life practice. This study is designed to evaluate the optimal use, efficacy, and safety of the T&E regimen with intravitreal aflibercept in subjects with nAMD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 287 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : November 19, 2015
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : April 26, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early-start T&E / Arm 1
Early-start T&E arm: test group, early treatment individualization
Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria

Active Comparator: Late-start T&E / Arm 2
Late-start T&E arm; per label, control group, treatment individualization after Year 1
Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
3 monthly doses followed by five 8-weekly doses (5 x 2Q8), then by individualized treatment intervals of between 8 to 16 weeks based on protocol-defined anatomical criteria




Primary Outcome Measures :
  1. Change in BCVA as Measured by the ETDRS Letter Score [ Time Frame: From Week 16 to Week 104 ]
    BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.


Secondary Outcome Measures :
  1. Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 104 Compared With Baseline [ Time Frame: at Week 104 ]
    Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.

  2. Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52 [ Time Frame: from baseline to Week 52, baseline to Week 104, and Week 16 to Week 52 ]
    BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.

  3. Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline [ Time Frame: At week 52 ]
    Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.

  4. Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline [ Time Frame: At Week 52 and Week 104 ]
    Participants gained 3 lines (15 letters) in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.

  5. Change in Central Retinal Thickness (CRT) [ Time Frame: From baseline to Week 52, baseline to Week 104, Week 16 to Week 52, and Week 16 to Week 104 ]
    CRT were evaluated using spectral domain Optical coherence tomograph (OCT).

  6. Number of Study Drug Injections From Baseline to Week 52 and Baseline to Week 104 [ Time Frame: At Week 52 and Week 104 ]
  7. Duration of Last Treatment Interval [ Time Frame: Early-Start T&E: from week 16 up to Week 104 or early termination; Late-Start T&E: From end of Year 1 up to Week 104 or early termination ]
  8. Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval [ Time Frame: at 8 weeks, 10 weeks, 12 weeks, 14 weeks, and 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581891


Locations
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Australia, New South Wales
Strathfield, New South Wales, Australia, 2135
Sydney, New South Wales, Australia, 2000
Westmead, New South Wales, Australia, 2145
Australia, Victoria
East Melbourne, Victoria, Australia, 3002
Australia
Launceston, Australia, 7249
Canada, Ontario
Hamilton, Ontario, Canada, L8G 5E4
Ottawa, Ontario, Canada, K2B 7E9
Canada, Quebec
Boisbriand, Quebec, Canada, J7H 1S6
France
Creteil Cedex, France, 94010
Nice cedex 1, France, 06006
Germany
Freiburg, Baden-Württemberg, Germany, 79106
Tübingen, Baden-Württemberg, Germany, 72076
Hannover, Niedersachsen, Germany, 30625
Bonn, Nordrhein-Westfalen, Germany, 53105
Köln, Nordrhein-Westfalen, Germany, 50924
Sulzbach, Saarland, Germany, 66280
Chemnitz, Sachsen, Germany, 09116
Berlin, Germany, 10713
Hungary
Budapest, Hungary, 1062
Budapest, Hungary, 1085
Budapest, Hungary, 1106
Budapest, Hungary, 1115
Budapest, Hungary, 1125
Budapest, Hungary, 1133
Debrecen, Hungary, 4032
Pecs, Hungary, 7621
Szombathely, Hungary, 9700
Italy
Roma, Lazio, Italy, 00198
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20157
Padova, Veneto, Italy, 35128
Spain
Oviedo, Asturias, Spain, 33012
Madrid, Spain
Zaragoza, Spain, 50009
United Kingdom
Canterbury, Kent, United Kingdom, CT1 3NG
Bristol, United Kingdom, BS1 2LX
Liverpool, United Kingdom, L7 8XP
London, United Kingdom, EC1V 2PD
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] February 2, 2016
Statistical Analysis Plan  [PDF] May 17, 2019

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02581891    
Other Study ID Numbers: 17508
2014-003132-39 ( EudraCT Number )
First Posted: October 21, 2015    Key Record Dates
Results First Posted: May 21, 2020
Last Update Posted: May 21, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bayer:
Neovascular age-related macular degeneration
nAMD)
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases