Status:
COMPLETED
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
Lead Sponsor:
Bayer
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
This study is a phase III, 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 ...
Detailed Description
Data of this trial ("VIEW 2") was pooled with data of a sister trial ("VIEW 1", NCT00509795), and an integrated analyses of the combined data was performed.
Eligibility Criteria
Inclusion
- 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 Fluorescein angiography (FA) in the study eye.
- ETDRS Best-Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 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) understand and willing to sign the informed consent form.
Exclusion
- 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.
- Any prior treatment with anti-VEGF agents in the study eye.
- Total lesion size \>12 disc areas (30.5 mm, including blood, scars and neovascularization) as assessed by FA in the study eye.
- Subretinal hemorrhages 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 by 270 degrees by visible CNV).
- Scar or fibrosis making up \>50% of the total lesion in the study eye.
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- 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.
- 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 it is unlikely to interfere with the injection.
- History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
1240 Patients enrolled
Trial Details
Trial ID
NCT00637377
Start Date
April 1 2008
End Date
August 1 2011
Last Update
December 12 2014
Active Locations (189)
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1
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1015ABO
2
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1023AAQ
3
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1122AAI
4
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1181ACH