Trial Condition(s):

Central Retinal Vein Occlusion

Evaluation of a Treat and Extend regimen of intravitreal aflibercept for macular edema secondary to CRVO (CENTERA)

Bayer Identifier:

17514

ClinicalTrials.gov Identifier:

NCT02800642

EudraCT Number:

2014-003193-17

Study Completed

Trial Purpose

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.

Inclusion Criteria
-  Center-involved macular edema secondary to CRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit).
 -  Adult subjects diagnosed with macular edema secondary to CRVO who are scheduled to be treated with IVT aflibercept as per investigator’s routine treatment practice with the intent to use a T&E regimen after initial dosing.
 -  Treatment-naïve subjects for macular edema secondary to CRVO.
 -  Men and women ≥ 18 years of age.
 -  Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40 to 20/320) in the study eye.
Exclusion Criteria
-  Previous PRP or macular laser photocoagulation in the study eye.
 -  Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to RVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded.
 -  Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study.
 -  Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1.
 -  Any active intraocular, extraocular, and periocular inflammation or infection in either
eye within 4 weeks of screening.
 -  Any history of allergy to povidone iodine.
 -  Known serious allergy to the fluorescein sodium for injection in angiography.
 -  Presence of any contraindications indicated in the EU commission/locally approved label for IVT aflibercept: hypersensitivity to the active substance IVT aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.

Trial Summary

Enrollment Goal
162
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Boisbriand, Canada, J7H 1S6

Status
Completed
 
Locations

Investigative Site

Göttingen, Germany, 37075

Status
Completed
 
Locations

Investigative Site

Heidelberg, Germany, 69120

Status
Completed
 
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Investigative Site

Köln, Germany, 50935

Status
Completed
 
Locations

Investigative Site

Münster, Germany, 48149

Status
Completed
 
Locations

Investigative Site

London, Canada, N6A 4V2

Status
Completed
 
Locations

Investigative Site

Sherbrooke, Canada, J1G 2V4

Status
Completed
 
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Investigative Site

Hamilton, Canada, L8G 5E4

Status
Completed
 
Locations

Investigative Site

Roma, Italy, 00133

Status
Completed
 
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Investigative Site

Ancona, Italy, 60126

Status
Completed
 
Locations

Investigative Site

Milano, Italy, 20132

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08024

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08025

Status
Completed
 
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Investigative Site

Oviedo, Spain, 33012

Status
Completed
 
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Investigative Site

Calgary, Canada, T2H 0C8

Status
Completed
 
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Investigative Site

Augsburg, Germany, 86156

Status
Completed
 
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Investigative Site

Bristol, United Kingdom, BS1 2LX

Status
Completed
 
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Investigative Site

Colchester, United Kingdom, CO3 3NB

Status
Completed
 
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Investigative Site

Freiburg, Germany, 79106

Status
Completed
 
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Investigative Site

Düsseldorf, Germany, 40225

Status
Completed
 
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Investigative Site

Sant Cugat del Vallés, Spain, 08195

Status
Completed
 
Locations

Investigative Site

Roma, Italy, 00198

Status
Completed
 
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Investigative Site

Padova, Italy, 35128

Status
Completed
 
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Investigative Site

Milano, Italy, 20157

Status
Completed
 
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Investigative Site

Bradford, United Kingdom, BD9 6RJ

Status
Completed
 
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Investigative Site

Liverpool, United Kingdom, L9 7AL

Status
Completed
 
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Investigative Site

Pisa, Italy, 56124

Status
Completed
 
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Investigative Site

Parramatta, Australia, 2150

Status
Completed
 
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Investigative Site

Sydney, Australia, 2000

Status
Completed
 
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Investigative Site

BORDEAUX, France, 33076

Status
Completed
 
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Investigative Site

Dijon Cedex, France, BP 1542-21

Status
Completed
 
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Investigative Site

LYON, France, 69004

Status
Completed
 
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Investigative Site

Oxford, United Kingdom, OX3 9DU

Status
Completed
 
Locations

Investigative Site

Glostrup, Denmark, 2600

Status
Completed
 
Locations

Investigative Site

Aalborg, Denmark, 9100

Status
Completed
 
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Investigative Site

Albury, Australia, 2640

Status
Completed
 
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Investigative Site

Quebec, Canada, G1V 1T6

Status
Completed
 
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Investigative Site

Leipzig, Germany, 04103

Status
Completed
 
Locations

Investigative Site

Hannover, Germany, 30625

Status
Completed
 
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Investigative Site

Karlsruhe, Germany, 76133

Status
Completed
 
Locations

Investigative Site

Sunderland, United Kingdom, SR2 9HP

Status
Completed
 
Locations

Investigative Site

Viladecans, Spain, 08840

Status
Completed
 

Trial Design