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

Macular Degeneration Clinical Trial

Official title:

A Randomized, Double-masked, Photodynamic Therapy-controlled Phase-3 Study of the Efficacy, Safety, and Tolerability of Intravitreal VEGF Trap-Eye in Chinese Subjects With Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482910
• Other study ID #: 13406
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2011
• Last updated: August 25, 2015
• Start date: December 2011
• Est. completion date: August 2014

Study information

• Verified date: August 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into the eyeball 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.

Description:

Adverse events collection will be covered in Adverse Events section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

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

Drug:
• Visudyne
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and at week 28	No
Secondary	Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - 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.	At week 28	No

External Links

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