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

NCT02645747 | Completed

• 1 other identifier: 18586
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (4)

• Treatment duration

  At 12 months of treatment with Eylea

• Number of eyes treated (mono-and biocular)

  At 12 months of treatment with Eylea

• Change in visual acuity (BCVA score)

  At 12 months of treatment with Eylea

• Number of Eylea injections per treated eye

  At 12 months of treatment with Eylea

Secondary Outcomes (3)

• 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

• Number of patients who discontinued their treatment with Eylea prematurely

  At 12 months of treatment with Eylea

Study Arms (1)

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)

Interventions

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, Belgium

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 5, 2016
• Study Start: January 21, 2016
• Primary Completion: December 23, 2017
• Study Completion: December 23, 2017
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

BE (1)