Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization

Choroidal Neovascularization Clinical Trial

Official title:

Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260687
• Other study ID #: 17416
• Secondary ID: EY1414JP
• Status: Completed
• Start date: December 5, 2014
• Est. completion date: August 22, 2018

Study information

• Verified date: September 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objectives of this study are to investigate the safety and effectiveness of EYLEA.

Description:

This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. 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 1 years or until it is no longer possible (e.g. lost to follow-up within the 1 year ). In total, 300 patients will be recruited.

For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice) .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: August 22, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who start EYLEA treatment for mCNV(myopic choroidal neovascularization).

Exclusion Criteria:

• Patients who have already received EYLEA treatment.

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Neovascularization, Pathologic

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of Adverse drug reaction (ADR's)		Up to 12 months
Primary	Number of episodes of Infections		Up to 12 months
Primary	Number of episodes of Serious Adverse Events(SAE's)		Up to 12 months
Primary	Number of episodes of Ocular Adverse events		Up to 12 months
Secondary	Mean changes in visual acuity		Baseline up to 12 months
Secondary	Mean changes in retina thickness		Baseline up to 12 months

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