Clinical trial NCT00637377: Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Keywords: Eye diseases
Vision Impairment and Blindness
Eyes and Vision
Seniors
Neovascular Age-Related Macular Degeneration (AMD)
Retinal Disease
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2008-03-18
Enrollment: 1240
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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 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 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.
* 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.

Primary outcomes:
measure: Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)
timeFrame: At week 52
Secondary outcomes:
measure: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF
timeFrame: Baseline and at week 52
measure: Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF
timeFrame: At week 52
measure: Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF
timeFrame: Baseline and at week 52
measure: Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF
timeFrame: Baseline and at week 52
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Buenos Aires
country: Argentina
state: Ciudad Auton. de Buenos Aires
city: Rosario
country: Argentina
state: Santa Fe
city: Córdoba
country: Argentina
city: Chatswood
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: East Melbourne
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Parramatta
country: Australia
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Wien
country: Austria
city: Liege
country: Belgium
city: Ribeirão Preto
country: Brazil
state: Sao Paulo
city: São Paulo
country: Brazil
state: Sao Paulo
city: Minas Gerais
country: Brazil
city: Sao Paulo
country: Brazil
city: Medellín
country: Colombia
state: Antioquia
city: Cali
country: Colombia
state: Cauca
city: Bogota
country: Colombia
state: Distrito Capital de Bogotá
city: Brno
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Praha 10
country: Czech Republic
city: Praha 4
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Paris
country: France
state: Cedex 12
city: Nantes
country: France
state: Cedex 1
city: Besancon
country: France
city: Bordeaux
country: France
city: Dijon
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Paris
country: France
city: Paris
country: France
city: Freiburg
country: Germany
state: Baden-Württemberg
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Darmstadt
country: Germany
state: Hessen
city: Aachen
country: Germany
state: Nordrhein-Westfalen
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Essen
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Ludwigshafen
country: Germany
state: Rheinland-Pfalz
city: Mainz
country: Germany
state: Rheinland-Pfalz
city: Homburg
country: Germany
state: Saarland
city: Dresden
country: Germany
state: Sachsen
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Kiel
country: Germany
state: Schleswig-Holstein
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Veszprem
country: Hungary
city: Ahemedabad - 4
country: India
state: Gujrat
city: Wadala, Mumbai
country: India
state: Maharashtra
city: Chennai
country: India
state: Tamil Nadu
city: Coimbatore
country: India
state: Tamil Nadu
city: Madurai
country: India
state: Tamil Nadu
city: Pondicherry
country: India
state: Tamil Nadu
city: Bangalore
country: India
city: Chandigarh
country: India
city: Hyderabad
country: India
city: Kerala
country: India
city: Kolkata
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: New Delhi
country: India
city: Orissa
country: India
city: Afula
country: Israel
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Tel Hashomer
country: Israel
city: Zrifin
country: Israel
city: Ancona
country: Italy
city: Bari
country: Italy
city: Catania
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
city: Varese
country: Italy
city: Verona
country: Italy
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Urayasu
country: Japan
state: Chiba
city: Maebashi
country: Japan
state: Gunma
city: Sapporo
country: Japan
state: Hokkaido
city: Kita
country: Japan
state: Kagawa
city: Hirakata
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Otsu
country: Japan
state: Shiga
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Kagoshima
country: Japan
city: Kyoto
country: Japan
city: Seongnam
country: Korea, Republic of
state: Gyeonggido
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Mexico City
country: Mexico
state: Distrito Federal
city: Zapopan
country: Mexico
state: Jalisco
city: Metepec
country: Mexico
state: México
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Chihuahua
country: Mexico
city: Mexico City
country: Mexico
city: México D.F.
country: Mexico
city: Leiden
country: Netherlands
state: ZA
city: Amsterdam
country: Netherlands
city: Groningen
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Poznan
country: Poland
city: Warszaa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Coimbra
country: Portugal
city: Porto
country: Portugal
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Santiago de Compostela
country: Spain
state: A Coruña
city: Oviedo
country: Spain
state: Asturias
city: Pamplona
country: Spain
state: Navarra
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Linköping
country: Sweden
city: Stockholm
country: Sweden
city: Örebro
country: Sweden
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Genève
country: Switzerland
city: Zürich
country: Switzerland
city: Southampton
country: United Kingdom
state: Hampshire
city: Camberley
country: United Kingdom
state: Surrey
city: Aberdeen
country: United Kingdom
city: Belfast
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Torquay
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17.
citation: Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, Ho AC, Ogura Y, Simader C, Jaffe GJ, Slakter JS, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Sowade O, Zeitz O, Norenberg C, Sandbrink R, Heier JS. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014 Jan;121(1):193-201. doi: 10.1016/j.ophtha.2013.08.011. Epub 2013 Sep 29.
citation: Moshfeghi DM, Thompson D, Saroj N. Changes in neovascular activity following fixed dosing with an anti-vascular endothelial growth factor agent over 52 weeks in the phase III VIEW 1 and VIEW 2 studies. Br J Ophthalmol. 2020 Sep;104(9):1223-1227. doi: 10.1136/bjophthalmol-2019-315021. Epub 2019 Dec 11.
citation: Yuzawa M, Fujita K, Wittrup-Jensen KU, Norenberg C, Zeitz O, Adachi K, Wang EC, Heier J, Kaiser P, Chong V, Korobelnik JF. Improvement in vision-related function with intravitreal aflibercept: data from phase 3 studies in wet age-related macular degeneration. Ophthalmology. 2015 Mar;122(3):571-8. doi: 10.1016/j.ophtha.2014.09.024. Epub 2014 Nov 6.
citation: Ogura Y, Terasaki H, Gomi F, Yuzawa M, Iida T, Honda M, Nishijo K, Sowade O, Komori T, Schmidt-Erfurth U, Simader C, Chong V; VIEW 2 Investigators. Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study. Br J Ophthalmol. 2015 Jan;99(1):92-7. doi: 10.1136/bjophthalmol-2014-305076. Epub 2014 Aug 8.