VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)

Bayer304 enrolled

Overview

This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual function in Chinese subjects with age-related neovascular or "wet" age-related macular degeneration. Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both treatment groups will receive the other treatment as a sham procedure.

Adverse events collection will be covered in Adverse Events section.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

304

Conditions

Macular Degeneration

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)BIOLOGICAL

Participants in the VEGF Trap-Eye group received intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks for an overall treatment period of 48 weeks. Additionally, sham PDT treatments was administered as needed.

VisudyneDRUG

Participants in the PDT group (Visudyne group) received Visudyne as needed. Additionally, sham IVT injections was administered until week 28. Thereafter, subjects in the PDT group received active (= no sham) VEGF Trap-Eye treatment until week 48.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed and dated informed consent form * Men and women ≥ 50 years of age. * Active predominantly classic subfoveal choroidal neovascularization (CNV) lesions secondary to wAMD (wet Age-Related Macular Degeneration) * BCVA (best corrected visual acuity) of 20/40 to 20/320 in the study eye Exclusion Criteria: * Only one functional eye * Presence of CNV with an origin other than wAMD * Any prior ocular or systemic treatment or surgery for wAMD, except dietary supplements or vitamins

Locations (14)

Unnamed facility

Guangzhou, Guangdong, China

Unnamed facility

Changsha, Hunan, China

Unnamed facility

Xi'an, Shaanxi, China

Unnamed facility

Qingdao, Shandong, China

Outcomes

Primary Outcomes

Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF)

Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.

Time frame: Baseline and at week 28

Secondary Outcomes

Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF

Time frame: At week 28

Data from ClinicalTrials.gov

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