Clinical Trial: Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization

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

Detailed Summary:

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) .


Sponsor: Bayer

Current Primary Outcome:

  • Number of episodes of Adverse drug reaction (ADR's) [ Time Frame: Up to 12 months ]
  • Number of episodes of Infections [ Time Frame: Up to 12 months ]
  • Number of episodes of Serious Adverse Events(SAE's) [ Time Frame: Up to 12 months ]
  • Number of episodes of Ocular Adverse events. [ Time Frame: Up to 12 months ]


Original Primary Outcome:

  • Number of episodes of Adverse drug reaction (ADR's) [ Time Frame: Up to 12 months ]
  • Number of episodes of Infections [ Time Frame: Up to 12 months ]
  • Number of episodes of Serious Adverse Events(SAE's) [ Time Frame: Up to 12 months ]
  • Number of episodes of Ocular Adverse events [ Time Frame: Up to 12 months ]


Current Secondary Outcome:

  • Mean changes in visual acuity [ Time Frame: Baseline up to 12 months ]
  • Mean changes in retina thickness [ Time Frame: Baseline up to 12 months ]


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: October 6, 2014
Date Started: December 5, 2014
Date Completion: March 31, 2019
Last Updated: May 15, 2017
Last Verified: May 2017