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Trial record 40 of 81 for:    CRVO - Central Retinal Vein Occlusion

Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion (RETRO CRVO)

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ClinicalTrials.gov Identifier: NCT02645747
Recruitment Status : Completed
First Posted : January 5, 2016
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Brief Summary:
The objective of this retrospective chart review is to evaluate drug utilization, usage patterns and indication of effectiveness Eylea in the routine clinical (real-life) management of patients who suffer from ME (Macular Edema), secondary to CRVO (Central Retinal Vein Occlusion), and who started treatment with Eylea for this indication.

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

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: RETRO CRVO: Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion
Actual Study Start Date : January 21, 2016
Actual Primary Completion Date : December 23, 2017
Actual Study Completion Date : December 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Aflibercept

Group/Cohort Intervention/treatment
Group 1
The source population of this study is patients who suffer from visual impairment due to ME secondary to CRVO. In order to ensure the representativeness of the study population, the number of Belgian patients which started Eylea treatment during the brief period between the 1st of June 2014 and the 28th of February 2015 were taken into account. However, data of patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.
Drug: Aflibercept (Eylea, BAY86-5321)

Eylea (intravitreal aflibercept) is an anti-Vascular Endothelial Growth Factor (VEGF) drug indicated for neovascular age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME) and visual impairment due to macular edema (ME) secondary to central or branched retinal vein occlusion (RVO).

RVO, both branch and central, is the second most common type of retinal vascular disorders after diabetic retinal disease. Central retinal vein occlusion (CRVO) is characterized by an obstruction of the central retinal vein combined with variable amounts of retinal arterial insufficiency.





Primary Outcome Measures :
  1. Treatment duration [ Time Frame: At 12 months of treatment with Eylea ]
  2. Number of eyes treated (mono-and biocular) [ Time Frame: At 12 months of treatment with Eylea ]
  3. Change in visual acuity (BCVA score) [ Time Frame: At 12 months of treatment with Eylea ]
  4. Number of Eylea injections per treated eye [ Time Frame: At 12 months of treatment with Eylea ]

Secondary Outcome Measures :
  1. Estimation of percentage (%) of eyes which need additional treatment after 2 years at the discretion of the treating physician. [ Time Frame: At 12 months of treatment with Eylea ]
  2. Sufficiency of reimbursed number of Eylea injections (max. 9 injections/eye in year 1) for treatment of all patients during the first year of treatment. [ Time Frame: At 12 months of treatment with Eylea ]
  3. Number of patients who discontinued their treatment with Eylea prematurely [ Time Frame: At 12 months of treatment with Eylea ]

    Investigator is asked to categorize the number of patients who ended their treatment prematurely according to the following reasons :

    • Lost-to-follow up (measured as number of patients)
    • Lack of efficacy (measured as number of patients)
    • Remission (measured as number of patients)
    • AE (measured as number of patients)
    • Other (measured as number of patients)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The source population of this study is patients who suffer from visual impairment due to macular edema secondary to central retinal vein occlusion.
Criteria

Inclusion Criteria:

  • Male or female adult patients who suffer from visual impairment due to ME secondary to CRVO
  • Anti-VEGF treatment-naive patients who started reimbursed Eylea treatment between the 1st of June 2014 and the 28th of February 2015

Exclusion Criteria:

  • Patients diagnosed with neovascular glaucoma secondary to CRVO will be excluded.

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): NCT02645747


Locations
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Belgium
Multiple Locations, Belgium
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: NCT02645747     History of Changes
Other Study ID Numbers: 18586
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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