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Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization

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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

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

Condition or disease Intervention/treatment
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) .


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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 : December 5, 2014
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Number of episodes of Adverse drug reaction (ADR's) [ Time Frame: Up to 12 months ]
  2. Number of episodes of Infections [ Time Frame: Up to 12 months ]
  3. Number of episodes of Serious Adverse Events(SAE's) [ Time Frame: Up to 12 months ]
  4. Number of episodes of Ocular Adverse events [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Mean changes in visual acuity [ Time Frame: Baseline up to 12 months ]
  2. Mean changes in retina thickness [ Time Frame: Baseline up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who have already received EYLEA treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02260687


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Regeneron Pharmaceuticals
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02260687     History of Changes
Other Study ID Numbers: 17416
EY1414JP ( Other Identifier: Company Internal )
First Posted: October 9, 2014    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by Bayer:
Aflibercept
Anti-VEGF
Additional relevant MeSH terms:
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Choroidal Neovascularization
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases