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

Study Overview
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Brief Summary
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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.

Detailed Description
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Adverse events collection will be covered in Adverse Events section.

Official Title
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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

Conditions
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Macular Degeneration

Intervention / Treatment
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* Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
* Drug: Visudyne


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aflibercept injection (EYLEA, VEGF Trap-Eye, BAY86-5321)<br>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. | Biological: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)<br>* 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.<br>|
| Active Comparator: PDT treatments<br>Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. | Drug: Visudyne<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |