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

Bayer

Status and phase: Completed; Phase 3

Conditions: Macular Degeneration

Treatments: Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Drug: Visudyne

Study type: Interventional

Funder types: Industry

Identifiers

NCT01482910

13406

Details and patient eligibility

About

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.

Full description

Adverse events collection will be covered in Adverse Events section.

Enrollment: 304 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

304 participants in 2 patient groups

Aflibercept injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Experimental group

Description:

Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.

Treatment:

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

PDT treatments

Active Comparator group

Description:

Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.

Treatment:

Drug: Visudyne