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Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02260687
Recruitment Status : Completed
First Posted : October 9, 2014
Last Update Posted : September 19, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date October 6, 2014
First Posted Date October 9, 2014
Last Update Posted Date September 19, 2019
Actual Study Start Date December 5, 2014
Actual Primary Completion Date April 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 6, 2014)
  • 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 Measures Same as current
Change History Complete list of historical versions of study NCT02260687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 6, 2014)
  • 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 Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization
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 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Female and male patients with mCNV(myopic choroidal neovascularization) diagnosis will be enrolled after the investigators have taken the decision for the treatment with EYLEA. Those patients who have had EYLEA prescribed previously will not be included in this study. Physicians should consult the full prescribing information for EYLEA before enrolling patients and be familiarized with the safety information in the product package label.
Condition Choroidal Neovascularization
Intervention Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection
Study Groups/Cohorts Group 1
Decision of treatment is made by attending investigator according to the Japanese Package Insert
Intervention: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 12, 2018)
353
Original Estimated Enrollment
 (submitted: October 6, 2014)
300
Actual Study Completion Date August 22, 2018
Actual Primary Completion Date April 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who have already received EYLEA treatment.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02260687
Other Study ID Numbers 17416
EY1414JP ( Other Identifier: Company Internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Regeneron Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date September 2019