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

Bayer287 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

287

Conditions

Macular Degeneration

Interventions

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

3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria

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

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (39)

Outcomes

Primary Outcomes

Change in BCVA as Measured by the ETDRS Letter Score

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.

Time frame: From Week 16 to Week 104

Secondary Outcomes

Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 104 Compared With Baseline

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.

Time frame: at Week 104

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

Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline

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.

Time frame: At week 52

Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline

Participants gained 3 lines (15 letters) in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.

Time frame: At Week 52 and Week 104

Change in Central Retinal Thickness (CRT)

Data from ClinicalTrials.gov

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