Phase 3
N=304
VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT01482910 ↗Enrolled (actual)
304
Serious AEs
4.2%
Results posted
Mar 2015
Primary outcome: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF) — 14.0; 3.9 Letters correctly read — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Biological); Visudyne (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF) |
14.0; 3.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Lost Fewer Than 15 Letters at Week 28 - LOCF |
98.7; 92.1 | 0.0359 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01482910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.