Vascular Endothelial Growth Factor VEGF Trap-Eye:Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration(AMD)

Phase 3

Completed

• Conditions: Macular Degeneration
• Interventions: Biological: ranibizumab; Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

• Registration Number: NCT00509795
• Lead Sponsor: Regeneron Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-31
• Study First Submitted QC: 2007-07-31
• Study Start: 2007-08
• Study First Posted: 2007-08-01
• Primary Completion: 2010-09
• Disposition First Submitted: 2011-01-05
• Disposition First Submitted QC: 2011-01-05
• Disposition First Posted: 2011-01-10
• Study Completion: 2011-07
• Results First Submitted: 2011-12-16
• Results First Submitted QC: 2012-04-13
• Results First Posted: 2012-04-16
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-20
• Last Update Posted: 2012-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1217

Inclusion Criteria

1. Signed Informed Consent.
2. Men and women ≥ 50 years of age.
3. 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.
4. 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.
5. Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
6. 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

1. Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.
2. Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye, except dietary supplements or vitamins.
3. Any prior treatment with anti-VEGF agents in the study eye.
4. Total lesion size > 12 disc areas (30.5 mm^2, including blood, scars and neovascularization) as assessed by FA in the study eye.
5. 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.)
6. Scar or fibrosis, making up > 50% of total lesion in the study eye.
7. Scar, fibrosis, or atrophy involving the center of the fovea.
8. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
9. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
10. Presence of other causes of CNV in the study eye.
11. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina,other than AMD, in either eye.
12. Prior vitrectomy in the study eye.
13. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
14. Any history of macular hole of stage 2 and above in the study eye.
15. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ranibizumab 0.5mg Q4	ranibizumab	-
aflibercept injection 2.0mg Q8	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	-
aflibercept injection 2.0mg Q4	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	-
aflibercept injection 0.5mg Q4	aflibercept injection (VEGF Trap-Eye, BAY86-5321)	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)	Baseline and at week 52	Defined "maintenance of vision" as patients who lost fewer than 15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) letter score compared to baseline.

Secondary Outcome Measures

Name	Time	Method
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	Baseline and at week 52	Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 (LOCF)	Baseline and at week 52	CNV area values measured in square millimeters (mm\^2); lower values represent better outcomes.
Mean Change From Baseline in National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF	Baseline and at Week 52	The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
Percentage of Patients Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF.	Baseline and at week 52	Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.