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

Status and phase: Completed; Phase 4

Conditions: Macular Degeneration

Treatments: Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02581891

17508

2014-003132-39 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 287 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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287 participants in 2 patient groups

Early-start T&E / Arm 1

Experimental group

Description:

Early-start T\&E arm: test group, early treatment individualization

Treatment:

Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)

Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)

Late-start T&E / Arm 2

Active Comparator group

Description:

Late-start T\&E arm; per label, control group, treatment individualization after Year 1

Treatment:

Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)

Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)