Overview

This trial is active, not recruiting.

Condition central retinal vein
Treatment aflibercept (eylea, bay 86-5321)
Sponsor Bayer
Collaborator Regeneron Pharmaceuticals
Start date January 2016
End date February 2017
Trial size 50 participants
Trial identifier NCT02645747, 18586

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective retrospective
Arm
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.
aflibercept (eylea, bay 86-5321)
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 Outcomes

Measure
Treatment duration
time frame: At 12 months of treatment with Eylea
Number of eyes treated (mono-and biocular)
time frame: At 12 months of treatment with Eylea
Change in visual acuity (BCVA score)
time frame: At 12 months of treatment with Eylea
Number of Eylea injections per treated eye
time frame: At 12 months of treatment with Eylea

Secondary Outcomes

Measure
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
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
Number of patients who discontinued their treatment with Eylea prematurely
time frame: At 12 months of treatment with Eylea

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title RETRO CRVO: Retrospective Data Analysis of Patients Treated for Macular Edema Due to Central Retinal Vein Occlusion
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.