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Completed

NCT Number: NCT02645747

Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion

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.

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aflibercept (Eylea, BAY86-5321)

Drug

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Acronym: RETRO CRVO

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 5, 2016
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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