Phase 3
N=1,217
Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)
Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT00509795 ↗Enrolled (actual)
1,217
Serious AEs
28.2%
Results posted
Apr 2012
Primary outcome: Primary: Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) — 94.4; 95.1; 95.9; 95.1 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ranibizumab (Biological); aflibercept injection (VEGF Trap-Eye, BAY86-5321) (Biological)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) |
94.4; 95.1; 95.9; 95.1; 95.1 | — |
| SECONDARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - LOCF |
8.1; 10.9; 6.9; 7.9; 8.5 | 0.0054 sig |
| SECONDARY Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF. |
30.9; 37.5; 24.9; 30.6; 31.1 | 0.1042 |
| SECONDARY Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF |
4.9; 6.7; 4.5; 5.1; 5.3 | 0.2090 |
| SECONDARY Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF) |
-4.2; -4.6; -3.5; -3.4; -3.9 | 0.3575 |
Summary
This study is a phase 3, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in the US and Canada.
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent.
- Men and women ≥ 50 years of age.
- Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
- Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) of: letter score of 73 to 25 (20/40 to 20/320) in the study eye at 4 meters.
- Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
- Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member. See Appendix J.4) understand and willing to sign the informed consent form.
Key
Exclusion Criteria
- Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
- Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
- Any prior treatment with anti-VEGF agents in the study eye.
- Total lesion size > 12 disc areas (30.5 mm^2, including blood, scars and neovascularization) as assessed by FA in the study eye.
- Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible CNV.)
- Scar or fibrosis, making up > 50% of total lesion in the study eye.
- Scar, fibrosis, or atrophy involving the center of the fovea.
- Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
- History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
- Presence of other causes of CNV in the study eye.
- History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than AMD, in either eye.
- Prior vitrectomy in the study eye.
- History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
- Any history of macular hole of stage 2 and above in the study eye.
- Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.
Data sourced from ClinicalTrials.gov (NCT00509795). 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.