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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02645747
Acronym
RETRO CRVO
Enrollment
126
Registered
2016-01-05
Start date
2016-01-21
Completion date
2017-12-23
Last updated
2018-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Vein Occlusion

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.

Interventions

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.

Sponsors

Regeneron Pharmaceuticals
CollaboratorINDUSTRY
Bayer
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of eyes treated (mono-and biocular)At 12 months of treatment with Eylea
Treatment durationAt 12 months of treatment with Eylea
Number of Eylea injections per treated eyeAt 12 months of treatment with Eylea
Change in visual acuity (BCVA score)At 12 months of treatment with Eylea

Secondary

MeasureTime frameDescription
Number of patients who discontinued their treatment with Eylea prematurelyAt 12 months of treatment with EyleaInvestigator 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)
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
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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026