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Aflibercept for neovascular age-related macular degeneration


Arm Name Suggestions

Arm Title Arm Description User Note
Intravitreal aflibercept 0.5 mg every 4 weeks
Intravitreal aflibercept 2.0 mg every 4 weeks
Intravitreal aflibercept 2.0 mg every 8 weeks
intravitreal aflibercept 2.0 mg every 8 weeks after 3 initial doses...
Intravitreal ranibizumab 0.5 mg every 4 weeks

Arm Details

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Design Details and Enrollment

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Outcome Name Suggestions

Outcome Title Note
Proportion of patients who lost >15 letters of BCVA at 1 year and 2 years
Mean change in BCVA at 1 year BCVA: best-corrected visual acuity
Proportion gaining greater than or equal to 15 letters
Quality-of-life improvement Change in total National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25) score
Change in CNV area on fluorescein angiography CNV: choroidal neovascularization
Retinal thickness Retinal thickness as assessed by Optical Coherence Tomography (OCT)
Absence of fluid events Persistent fluid as assessed by Optical Coherence Tomography (OCT)
Mean number of intravitreal injections
Mean change in BCVA at 2 years BCVA: best-corrected visual acuity


Outcome Details

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Row Headers
Yes
No
Baseline
One or more time points after baseline and ≤1 year
One or more time points after baseline >1 year and ≤2 years
Question 3

Adverse Events

Arm or Total Title Description Proportion of participants/eyes
Intravitreal aflibercept 0.5 mg every 4 weeks
Intravitreal aflibercept 2.0 mg every 4 weeks
Intravitreal aflibercept 2.0 mg every 8 weeks
Intravitreal ranibizumab 0.5 mg every 4 weeks
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