Trial Condition(s):
Macular degeneration
Vascular endothelial growth factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2)
Bayer Identifier:
91689
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Цель исследования
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.
Критерии включения
- 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.
Критерии исключения
- 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.
Резюме исследования
Enrollment Goal
Trial Dates
Phase
Могу ли я получить плацебо?
Products
Accepts Healthy Volunteers
Где принять участие
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Местоположения Gachon University Gil Medical Center Incheon, South Korea, 405-760 | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения Universitätsspital Basel Basel, Switzerland, 4031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения Regional Institute of Ophthalmology Kolkata, India, 700073 | Contact Us: E-mail: [email protected] Phone: Not Available |
Местоположения L.V. Prasad Eye Institute Hyderabad, India, 500 034 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Местоположения Aditya Jyot Eye Hospital Pvt. Ltd. Wadala, Mumbai, India, 400031 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Местоположения Paula Stradina Kliniskas Universitates slimnica Riga, Latvia, 1002 | Contact Us: E-mail: [email protected] Phone: Not Available |
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Проект исследования
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)Timeframe: At week 52
Secondary Outcome
- Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCFTimeframe: Baseline and at week 52
- Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCFTimeframe: At week 52
- Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCFTimeframe: Baseline and at week 52
- Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCFTimeframe: Baseline and at week 52
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