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

Macular Degeneration Clinical Trial

— VIEW 2  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637377
• Other study ID #: 91689
• Secondary ID: 2007-000583-25
• Status: Completed
• Phase: Phase 3
• First received: March 12, 2008
• Last updated: November 28, 2014
• Start date: April 2008
• Est. completion date: August 2011

Study information

• Verified date: November 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swiss MedicArgentina: Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Federal Office for Safety in Health CareBelgium: Federal Agency for Medicinal Products and Health ProductsBrazil: ANVISA Agencia Nacional de Vigilancia SanitariaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIndia: Drugs Controller General of IndiaIsrael: Ministry of HealthItaly: Ethics CommitteeJapan: Pharmaceuticals and Medical Devices AgencySouth Korea: Korea Food and Drug Administration (KFDA)Latvia: State Agency of MedicinesMexico: Federal Commission for Sanitary Risks ProtectionNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: INFARMED National Authority of Medicines and Health ProductsSingapore: Health Sciences AuthoritySlovakia: State Institute for Drug ControlSpain: Ministry of Health and ConsumptionSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1240
• Est. completion date: August 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  Brazil,  Colombia,  Czech Republic,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Latvia,  Mexico,  Netherlands,  Poland,  Portugal,  Singapore,  Slovakia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

References & Publications (2)

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 G — View 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. Intravitre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF)	Maintenance of vision was defined as a loss of < 15 letters in the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score (defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.; Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.	At week 52	No
Secondary	Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 52 - LOCF	Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.	Baseline and at week 52	No
Secondary	Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score in the Study Eye at Week 52 - LOCF	Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning.; Nominator = (Number of participants who maintained vision * 100); Denominator = Number of participants analyzed.	At week 52	No
Secondary	Mean Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 52 - LOCF	The possible range of the NEI VFQ-25 total score is between 0 (worst possible) and 100 (best possible).	Baseline and at week 52	No
Secondary	Mean Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 52 - LOCF	CNV area values measured in square millimeters; lower values represent better outcomes.	Baseline and at week 52	No

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