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

Retinal Vein Occlusion Clinical Trial

— RETRO CRVO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645747
• Other study ID #: 18586
• Status: Completed
• Start date: January 21, 2016
• Est. completion date: December 23, 2017

Study information

• Verified date: September 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 23, 2017
• Est. primary completion date: December 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment duration		At 12 months of treatment with Eylea
Primary	Number of eyes treated (mono-and biocular)		At 12 months of treatment with Eylea
Primary	Change in visual acuity (BCVA score)		At 12 months of treatment with Eylea
Primary	Number of Eylea injections per treated eye		At 12 months of treatment with Eylea
Secondary	Estimation of percentage (%) of eyes which need additional treatment after 2 years at the discretion of the treating physician.		At 12 months of treatment with Eylea
Secondary	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.		At 12 months of treatment with Eylea
Secondary	Number of patients who discontinued their treatment with Eylea prematurely	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)	At 12 months of treatment with Eylea

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