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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,240
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.
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.
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.
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.
Time frame: At week 52
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.
Time frame: 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 - 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.
Time frame: At week 52
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).
Time frame: Baseline and at week 52
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Unnamed facility
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Unnamed facility
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Unnamed facility
Córdoba, Córdoba Province, Argentina
Unnamed facility
Rosario, Santa Fe Province, Argentina
Unnamed facility
Chatswood, New South Wales, Australia
Unnamed facility
Sydney, New South Wales, Australia
Unnamed facility
Westmead, New South Wales, Australia
Unnamed facility
East Melbourne, Victoria, Australia
...and 179 more locations
Time frame: Baseline and at week 52