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Safety, Tolerability, and Eff...

Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

Last Updated: 2023-08-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-04

Study Completion Date

2021-11-30

Brief Summary

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The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).

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Detailed Description

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Conditions

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Neovascular (Wet) Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Single-masked: The patients, visual acuity examiners, imaging technicians and reading center will be masked to treatment assignment.

Study Groups

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intravitreal aflibercept injection (IAI)

Treatment-naïve patients with neovascular "wet" age-related macular degeneration (nAMD) randomized in a 1:1 ratio

Group Type EXPERIMENTAL

aflibercept

Intervention Type DRUG

Intravitreally (IVT) administered as a liquid formulation in a vial

High-dose aflibercept (HD)

Treatment-naïve patients with nAMD randomized in a 1:1 ratio

Group Type EXPERIMENTAL

High-dose aflibercept

Intervention Type DRUG

Intravitreally (IVT) administered as a liquid formulation in a vial

Interventions

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aflibercept

Intravitreally (IVT) administered as a liquid formulation in a vial

Intervention Type DRUG

High-dose aflibercept

Intravitreally (IVT) administered as a liquid formulation in a vial

Intervention Type DRUG

Other Intervention Names

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EYLEA® BAY86-5321

Eligibility Criteria

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Inclusion Criteria

* Men or women ≥50 years of age with active subfoveal choroidal neovascularization (CNV) secondary to nAMD
* Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 78 to 24 (Snellen equivalent of 20/32 to 20/320) in the study eye

Exclusion Criteria

* Evidence of CNV due to any cause other than nAMD in either eye
* Evidence of diabetic macular edema (DME) or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
* Prior use of IVT anti-VEGF agents (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) in the study eye
* Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy)
* Previous use of intraocular or periocular corticosteroids within 120 days of screening or treatment with an IVT steroid implant at any time in the study eye
* History of vitreoretinal surgery (including scleral buckling) in the study eye
* Any other intraocular surgery within 12 weeks (84 days) before the screening visit
* History of corneal transplant or corneal dystrophy in study eye

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers