Resumen

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 be randomized in Europe, Asia, Japan, Australia and South America.

Descripción detallada

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.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Ranibizumab

Participants received a 0.5 mg dose of Ranibizumab via intravitreal (IVT) injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

biological

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Participants received a 2.0 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

biological

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Participants received a 0.5 mg dose of Aflibercept Injection administered every 4 weeks for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

biological

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Participants received a 2.0 mg dose of Aflibercept Injection administered every 8 weeks (including one additional 2,0 mg dose at Week 4) for the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks.

A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Ranibizumab

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)

Ubicaciones

Patrocinadores