To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
177
Intravitreal injection. Weeks 0 to 20 of Aflibercept Injection every 4 weeks; Weeks 24 to 52 every 4 weeks PRN (pro re nata, on demand); plus additional on Week 60 and 68.
Sham treatment. Weeks 0 to 52 sham treatment every 4 weeks; plus additional on Week 60 and 68.
Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures
Defined study baseline range of Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score of 73 to 24 (= 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: Baseline and Week 24
Change From Baseline in BCVA as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 24 - Last Observation Carried Forward (LOCF)
Defined study baseline range of ETDRS Best Corrected Visual Acuity letter score of 73 to 24 (= Acuity of 20/40 to 20/320) in the study eye; a higher score represents better functioning. However, because this was assessed at the screening visit, subjects may have had a higher BCVA recorded at the baseline visit and would not have been excluded from the study.
Time frame: Baseline and Week 24
Change From Baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
Time frame: Baseline and Week 24
Percentage of Participants Who Developed Neovascularization During the First 24 Weeks
Formation of blood vessels in the anterior segment, optic disc, or elsewhere in the fundus up to Week 24
Time frame: From baseline until Week 24
Change From Baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score at Week 24 - LOCF
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight
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Unnamed facility
Chatswood, New South Wales, Australia
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Parramatta, New South Wales, Australia
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Sydney, New South Wales, Australia
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Westmead, New South Wales, Australia
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East Melbourne, Victoria, Australia
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Nedlands, Western Australia, Australia
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Innsbruck, Austria
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Linz, Austria
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Vienna, Austria
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Paris, Cedex 12, France
...and 63 more locations
Time frame: Baseline and Week 24
Change From Baseline in European Five-dimensional Health Scale (EQ-5D) Score at Week 24 - LOCF
EQ-5D is a quality of life questionnaire based on a scale from -0.594 (worst) to 1.00 (best).
Time frame: Baseline and Week 24