Trial intelligence / Profile preview

VEGF Trap-Eye in myopic choroidal neovascularization

NCT01249664Phase 3

Key facts

Status: Completed
Start: Dec 2010
Primary completion: Feb 2013
Countries: 5
Sponsor: Bayer
Modality: Engineered Antibody Formats, Fc-Fusion Proteins

Drugs: aflibercept
Conditions: myopic choroidal neovascularization (mCNV)

Overview

Phase 3, randomised, double-blind trial of aflibercept in myopic choroidal neovascularization (mCNV) (2 arms), sponsored by Bayer. Primary endpoint: Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS at 24 weeks. Started Dec 2010; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

VEGF Trap-Eye
Intravitreal aflibercept injection
Sham
Sham procedure (simulated injection)

Who it enrols

Patients with active subfoveal or juxtafoveal CNV secondary to pathologic myopia, BCVA 73-35 letters, and no prior anti-VEGF treatment.

Endpoints

Primary

Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS24 weeks

Secondary

Percentage of Participants Who Gained at Least 15 Letters in BCVA48 weeks
Percentage of Participants Who Gained at Least 10 Letters in BCVA48 weeks
Percentage of Participants Who Gained at Least 5 Letters in BCVA48 weeks
Percentage of Participants Who Lost at Least 15 Letters in BCVA48 weeks
Mean Change in Central Retinal Thickness (CRT)48 weeks
Mean Change in Choroidal Neovascularization (CNV) Lesion Size48 weeks
Mean Change in European Five-dimensional Health Scale (EQ-5D) Score24 weeks
Mean Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score24 weeks

Results

Primary endpoints met

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