Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO)

NCT02040220 | Completed

• 2 other identifiers: 16641EYL-CRVO
• Study Type: observational
• Target: 385
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study. The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. For each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice). There will interim analysis of study data: 6 months after last patient first visit and J-PSUR(Japanese-Periodic Safety Update Report )

Conditions

Retinal Vein Occlusion

Keywords

CRVO, Macular edema, Aflibercept, anti-VEGF

Outcome Measures

Primary Outcomes (1)

• Number of episodes of adverse drug reactions and adverse events(serious or non-serious, related or not related, ocular or non ocular)

  6 months after start of treatment with the drug

Secondary Outcomes (2)

• Effectiveness (visual acuity)

  6months after start of treatment with the drug

• Effectiveness (retina thickness)

  6months after start of treatment with the drug

Study Arms (1)

Group 1

Eylea treatment goup

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) DRUG

2 mg of Eylea will be treated per one injection at more than one months interval usually.

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female and male patients with a diagnosis of CRVO will be enrolled after the decision for treatment with EYLEA has been made by the investigator. Those patients prescribed EYLEA previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and familiarize themselves with the safety information in the product package label. Eligible patients who receive EYLEA will be enrolled and documented in the eCRF.

You may qualify if:

• Patients who start EYLEA treatment for CRVO

You may not qualify if:

• Patients who have already received EYLEA treatment
• Patients who are contraindicated based on approved label

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

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

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 20, 2014
• Study Start: January 24, 2014
• Primary Completion: June 1, 2018
• Study Completion: November 9, 2018
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

JP (1)