Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood away from the retina (the very back portion of the eye) becomes blocked, causing the leakage of fluid into the retina and thereby causing a swelling of the macula (the portion of the retina responsible for fine vision). This swelling is called macular edema. When the macula swells with fluid, central vision becomes blurry. The study drug aflibercept has been shown to reduce the amount of fluid and blood leaked into the retina. It can help to stabilize, and in many cases, improve the vision loss related to CRVO. Aflibercept has been approved for the treatment of macular edema secondary to CRVO in the United States (US), European Union (EU), Japan, and other countries. The study was considered research because, although the study drug was already on the market for macular edema secondary to CRVO, there were no studies available that addressed the questions of what were useful intervals for treating and assessing patients, how did they differ among patients, and how were criteria applied for retreatment. The purpose of this study was to evaluate the effectiveness, treatment interval, and safety of the treatment regimen (pattern for administering treatment) in subjects with macular edema secondary to CRVO. In addition, this study explored new imaging methods for assessing the affected eye.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
162
The recommended dose for intravitreal aflibercept was 2 mg equivalent to 50 μL. Study treatment was administered at baseline and at monthly intervals until stabilization of disease. When stability was achieved, the treatment interval could be extended based on visual and anatomic outcomes as judged by the treating investigator.
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Albury, New South Wales, Australia
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Sydney, New South Wales, Australia
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Parramatta, Australia
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Calgary, Alberta, Canada
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Hamilton, Ontario, Canada
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The Proportion of Participants Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline
Participants who completed the study with a gain of ≥ 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of ≥ 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity.
Time frame: Baseline, Week 24 and Week 76
The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks
Participants who completed the study with a mean treatment interval between injections of ≥ 8 weeks or dropped out of the study after Week 24 and having a permanent resolution of macular edema
Time frame: From the last actual visit of the initiation phase to Week 76
The Mean Treatment Interval Between Injections
Time frame: From baseline to Week 76
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline
The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
Time frame: Baseline and Week 24, 52, and 76
The Change in Central Retinal Thickness (CRT) From Baseline
CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Time frame: Baseline and Week 24, 52 and 76
The Number of Injections Per Participant
Time frame: From baseline to Week 76
The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline
The ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuity
Time frame: Baseline and Week 24, Week 52
The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline
The change in retinal non-perfusion status by fundus angiography (FA)/fundus photography (FP)-confirmed ischemic disc area. The status was categorized into: no non-perfusion, \<10 ischemic disc area, \>=10 ischemic disc area and missing status
Time frame: Baseline and Week 24, 52 and 76
The Proportion of Participants With Absence of Subretinal Fluid
Time frame: Baseline, week 24, week 52 and week 76
Incidence and Severity of Ocular Treatment-emergent Adverse Events
Time frame: Up to 30 days after week 76
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London, Ontario, Canada
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Boisbriand, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Québec, Canada
Unnamed facility
Aalborg, Denmark
...and 32 more locations