- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02260687
Special Drug Use Investigation of EYLEA for Myopic Choroidal Neovascularization
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Multiple Locations, Japan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who start EYLEA treatment for mCNV(myopic choroidal neovascularization).
Exclusion Criteria:
- Patients who have already received EYLEA treatment.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Decision of treatment is made by attending investigator according to the Japanese Package Insert
|
Administration by intravitreal injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of episodes of Adverse drug reaction (ADR's)
Time Frame: Up to 12 months
|
Up to 12 months
|
Number of episodes of Infections
Time Frame: Up to 12 months
|
Up to 12 months
|
Number of episodes of Serious Adverse Events(SAE's)
Time Frame: Up to 12 months
|
Up to 12 months
|
Number of episodes of Ocular Adverse events
Time Frame: Up to 12 months
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean changes in visual acuity
Time Frame: Baseline up to 12 months
|
Baseline up to 12 months
|
Mean changes in retina thickness
Time Frame: Baseline up to 12 months
|
Baseline up to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17416
- EY1414JP (Other Identifier: Company Internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Choroidal Neovascularization
-
Hospices Civils de LyonCompletedInflammatory Choroidal NeovascularizationFrance
-
Jiao MingfeiUnknownIdiopathic Choroidal NeovascularizationChina
-
Hospices Civils de LyonCompletedStudy Evaluating the Efficacy of Aflibercept for the Treatment of NVCI in Young Patients (INTUITION)Idiopathic Choroidal NeovascularizationFrance
-
Instituto de Olhos de GoianiaUnknownChoroidal Retinal NeovascularizationBrazil
-
Asociación para Evitar la Ceguera en MéxicoCentro Medico IssemymUnknownSubfoveal Choroidal NeovascularizationMexico
-
Poitiers University HospitalCompletedType 3 Choroidal NeovascularizationFrance
-
Novartis PharmaceuticalsCompletedChoroidal Neovascularization (CNV)Korea, Republic of, Germany, Russian Federation, Turkey, Australia, Hungary, Switzerland, Italy, Lithuania, Denmark, Peru, Spain, Portugal, Canada, France, Latvia, Greece, Slovakia, Czech Republic, Poland, Singapore
-
University Hospital, LimogesUnknownChoroidal Neovascularization, Visual Field, Visual AcuityFrance
-
Instituto de Olhos de GoianiaUnknown
-
Instituto de Olhos de GoianiaCompletedMyopic Choroidal NeovascularizationBrazil
Clinical Trials on Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
-
BayerCompleted
-
BayerRegeneron PharmaceuticalsActive, not recruitingNeovascular Age-Related Macular DegenerationUnited States, Spain, Korea, Republic of, Czechia, Japan, Singapore, China, Serbia, Lithuania, Taiwan, Australia, Estonia, Austria, Israel, France, Italy, Switzerland, Slovakia, Ukraine, Bulgaria, Portugal, Latvia, Canada, Hungary, Arge... and more
-
BayerRegeneron PharmaceuticalsRecruitingMacular Edema Secondary to Retinal Vein OcclusionJapan, Korea, Republic of, China, Israel, Lithuania, United States, Italy, Spain, Hungary, Portugal, Serbia, Poland, United Kingdom, Thailand, Czechia, Austria, Germany, Turkey, Australia, Bulgaria, Estonia, France, Georgia, Latvia, Mal... and more
-
Regeneron PharmaceuticalsBayerCompleted
-
Regeneron PharmaceuticalsBayerCompletedMacular DegenerationUnited States, Canada
-
BayerCompletedMacular Degeneration | Choroidal NeovascularizationGreece
-
BayerCompletedMacular EdemaSpain, Canada, Switzerland, Portugal, Austria, Poland, Slovakia, United Kingdom, Germany, Hungary, Italy, France, Lithuania, Czechia
-
BayerRegeneron PharmaceuticalsCompleted
-
BayerRegeneron PharmaceuticalsCompletedMacular DegenerationJapan
-
BayerRegeneron PharmaceuticalsCompletedWet Age-related Macular DegenerationGermany