Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO (CENTERA)
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|ClinicalTrials.gov Identifier: NCT02800642|
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : March 12, 2019
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 is considered research because, although the study drug is already on the market for macular edema secondary to CRVO, there are no studies available that address the questions of what are useful intervals for treating and assessing patients, how do they differ among patients, and how are criteria applied for retreatment. The purpose of this study is 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 will explore new imaging methods for assessing the affected eye.
|Condition or disease||Intervention/treatment||Phase|
|Central Retinal Vein Occlusion||Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Single-arm, Interventional Phase 4 Study to Evaluate a Treat and Extend Regimen of Intravitreal Aflibercept for Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion|
|Actual Study Start Date :||June 10, 2016|
|Estimated Primary Completion Date :||August 29, 2019|
|Estimated Study Completion Date :||August 29, 2019|
Experimental: Aflibercept / Arm 1
Subjects with macular edema secondary to CRVO will be treated with the study drug intravitreal aflibercept.
Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
The recommended dose for intravitreal aflibercept is 2 mg equivalent to 50 μL Study treatment will be administered at baseline and at monthly intervals until stabilization of disease. When stability is achieved, the treatment interval can be extended based on visual and anatomic outcomes as judged by the treating investigator.
- The proportion of subjects who gain ≥ 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy score chart [ Time Frame: Compared with baseline at Week 76 ]
- The proportion of subjects with a mean treatment interval between injections of ≥ 8 weeks [ Time Frame: From the last actual visit of the initiation phase to Week 76 ]
- The change in best corrected visual acuity as measured by the early treatment diabetic retinopathy letter score [ Time Frame: From baseline to Weeks 24, 52, and 76 ]
- The change in central retinal thickness [ Time Frame: From baseline to Weeks 24, 52, and 76 ]
- The number of injections [ Time Frame: From baseline to Week 76 ]
- The mean treatment interval between injections [ Time Frame: From baseline to Week 76 ]
- The proportion of subjects who gain ≥ 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy chart [ Time Frame: Compared with baseline at Weeks 24 and 52 ]
- The change in retinal perfusion (FA/FP) status [ Time Frame: At Weeks 24, 52, and 76 ]
- Number and severity of ocular safety events detected by tonometry, indirect ophthalmoscopy, slit lamp biomicroscopy, and gonioscopy [ Time Frame: 30 days after week 76 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800642
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|Study Director:||Bayer Study Director||Bayer|