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Trial record 3 of 320 for:    Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | 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)

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ClinicalTrials.gov Identifier: NCT02581891
Recruitment Status : Active, not recruiting
First Posted : October 21, 2015
Last Update Posted : May 24, 2018
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.


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
Estimated Primary Completion Date : April 25, 2019
Estimated Study Completion Date : April 25, 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 best corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score [ Time Frame: Week 104 ]

Secondary Outcome Measures :
  1. Proportion of subjects maintaining vision (<3 lines loss) [ Time Frame: Weeks 52 and 104 ]
  2. Change in BCVA as measured by the ETDRS letter score [ Time Frame: Weeks 52 and 104 ]
  3. Change in central retinal thickness (CRT) [ Time Frame: Weeks 52 and 104 ]
  4. Number of study drug injections [ Time Frame: Weeks 52 and 104 ]
  5. Duration of last re-treatment interval [ Time Frame: Week 104 ]
  6. Proportion of subjects requiring retreatment at 8, 10, 12, 14, and 16 weeks as the last treatment interval [ Time Frame: Week 104 ]
  7. Proportion of 3-line vision gainers [ Time Frame: Weeks 52 and 104 ]


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


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Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02581891     History of Changes
Other Study ID Numbers: 17508
2014-003132-39 ( EudraCT Number )
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

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:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases