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Trial record 23 of 81 for:    CRVO - Central Retinal Vein Occlusion

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
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
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
Estimated Primary Completion Date : August 29, 2019
Estimated Study Completion Date : August 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. The change in central retinal thickness [ Time Frame: From baseline to Weeks 24, 52, and 76 ]
  3. The number of injections [ Time Frame: From baseline to Week 76 ]
  4. The mean treatment interval between injections [ Time Frame: From baseline to Week 76 ]
  5. 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 ]
  6. The change in retinal perfusion (FA/FP) status [ Time Frame: At Weeks 24, 52, and 76 ]
  7. Number and severity of ocular safety events detected by tonometry, indirect ophthalmoscopy, slit lamp biomicroscopy, and gonioscopy [ Time Frame: 30 days after week 76 ]


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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


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Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02800642     History of Changes
Other Study ID Numbers: 17514
2014-003193-17 ( EudraCT Number )
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

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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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Retinal Vein Occlusion
Retinal Degeneration
Retinal Diseases
Venous Thrombosis
Macular Edema
Macular Degeneration
Eye Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases