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Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO (CENTERA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800642
Recruitment Status : Completed
First Posted : June 15, 2016
Results First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Drug: Aflibercept (Eylea, BAY86-5321) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Primary Completion Date : July 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Intravitreal (IVT) aflibercept
Participants with macular edema secondary to CRVO were treated with the study drug intravitreal aflibercept
Drug: Aflibercept (Eylea, BAY86-5321)
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.




Primary Outcome Measures :
  1. 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 [ Time Frame: Baseline, Week 24 and Week 76 ]
    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.

  2. The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks [ Time Frame: From the last actual visit of the initiation phase to Week 76 ]
    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


Secondary Outcome Measures :
  1. The Mean Treatment Interval Between Injections [ Time Frame: From baseline to Week 76 ]
  2. The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline [ Time Frame: Baseline and Week 24, 52, and 76 ]
    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

  3. The Change in Central Retinal Thickness (CRT) From Baseline [ Time Frame: Baseline and Week 24, 52 and 76 ]
    CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).

  4. The Number of Injections Per Participant [ Time Frame: From baseline to Week 76 ]
  5. 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 [ Time Frame: Baseline and Week 24, Week 52 ]
    The ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuity

  6. The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline [ Time Frame: Baseline and Week 24, 52 and 76 ]
    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

  7. The Proportion of Participants With Absence of Subretinal Fluid [ Time Frame: Baseline, week 24, week 52 and week 76 ]
  8. Incidence and Severity of Ocular Treatment-emergent Adverse Events [ Time Frame: Up to 30 days after week 76 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Australia, New South Wales
Albury, New South Wales, Australia, 2640
Sydney, New South Wales, Australia, 2000
Australia
Parramatta, Australia, 2150
Canada, Alberta
Calgary, Alberta, Canada, T2H 0C8
Canada, Ontario
Hamilton, Ontario, Canada, L8G 5E4
London, Ontario, Canada, N6A 4V2
Canada, Quebec
Boisbriand, Quebec, Canada, J7H 1S6
Sherbrooke, Quebec, Canada, J1G 2V4
Canada
Quebec, Canada, G1V 1T6
Denmark
Aalborg, Denmark, 9100
Glostrup, Denmark, 2600
France
Bordeaux, France, 33076
Dijon Cedex, France, BP 1542-21
Lyon, France, 69004
Germany
Freiburg, Baden-Württemberg, Germany, 79106
Heidelberg, Baden-Württemberg, Germany, 69120
Karlsruhe, Baden-Württemberg, Germany, 76133
Augsburg, Bayern, Germany, 86156
Göttingen, Niedersachsen, Germany, 37075
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Hannover, Nordrhein-Westfalen, Germany, 30625
Köln, Nordrhein-Westfalen, Germany, 50935
Münster, Nordrhein-Westfalen, Germany, 48149
Leipzig, Sachsen, Germany, 04103
Italy
Roma, Lazio, Italy, 00133
Roma, Lazio, Italy, 00198
Milano, Lombardia, Italy, 20132
Milano, Lombardia, Italy, 20157
Ancona, Marche, Italy, 60126
Pisa, Toscana, Italy, 56124
Padova, Veneto, Italy, 35128
Spain
Oviedo, Asturias, Spain, 33012
Sant Cugat del Vallés, Barcelona, Spain, 08195
Viladecans, Barcelona, Spain, 08840
Barcelona, Spain, 08024
Barcelona, Spain, 08025
United Kingdom
Sunderland, Tyne And Wear, United Kingdom, SR2 9HP
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Bristol, United Kingdom, BS1 2LX
Colchester, United Kingdom, CO3 3NB
Liverpool, United Kingdom, L9 7AL
Oxford, United Kingdom, OX3 9DU
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] April 20, 2016
Statistical Analysis Plan  [PDF] November 14, 2019

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02800642    
Other Study ID Numbers: 17514
2014-003193-17 ( EudraCT Number )
First Posted: June 15, 2016    Key Record Dates
Results First Posted: July 8, 2020
Last Update Posted: July 8, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Bayer:
Bayer
Aflibercept
Eylea
Intravitreal
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases