Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02260687
• Collaborator: Regeneron Pharmaceuticals (Industry)
• Enrollment: 353
• Location: 1
• Actual Duration (Months): 44.6
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Choroidal Neovascularization	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Detailed 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) .

Study Design

• Study Type: Observational
• Actual Enrollment: 353 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization
• Actual Study Start Date: Dec 5, 2014
• Actual Primary Completion Date: Apr 2, 2018
• Actual Study Completion Date: Aug 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Group 1 Decision of treatment is made by attending investigator according to the Japanese Package Insert	Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Administration by intravitreal injection

Outcome Measures

Primary Outcome Measures

1. Number of episodes of Adverse drug reaction (ADR's) [Up to 12 months]

2. Number of episodes of Infections [Up to 12 months]

3. Number of episodes of Serious Adverse Events(SAE's) [Up to 12 months]

4. Number of episodes of Ocular Adverse events [Up to 12 months]

Secondary Outcome Measures

1. Mean changes in visual acuity [Baseline up to 12 months]

2. Mean changes in retina thickness [Baseline up to 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who have already received EYLEA treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Multiple Locations		Japan

Sponsors and Collaborators

• Bayer
• Regeneron Pharmaceuticals

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here to find results for studies related to Bayer products

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02260687
• Other Study ID Numbers: 17416; EY1414JP
• First Posted: Oct 9, 2014
• Last Update Posted: Sep 19, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Bayer: Aflibercept; Anti-VEGF
• Additional relevant MeSH terms: Choroidal Neovascularization; Neovascularization, Pathologic; Aflibercept

Study Results

No Results Posted as of Sep 19, 2019