High Myopia: Extended and Longterm Observation of Pathologic Myopia Patients With the Risk for Developing a Myopic Choroidal Neovascularization (CNV)
NCT ID: NCT03070717
Last Updated: 2019-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
153 participants
OBSERVATIONAL
2014-06-12
2019-05-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All patients
Patients with diagnosis of high myopia secondary to an anterior-posterior elongation of the bulbus confirmed by ocular examination in either eye using specific criteria.
Observation & Diagnosis
SD-OCT, fundus autofluorescence, fundus photography, optional microperimetry, ophthalmic exams (BCVA, optical biometry), blood sampling.
Interventions
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Observation & Diagnosis
SD-OCT, fundus autofluorescence, fundus photography, optional microperimetry, ophthalmic exams (BCVA, optical biometry), blood sampling.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of high myopia secondary to an anterior-posterior elongation of the bulbus confirmed by ocular examination in either eye using the following criteria:
* Ocular ultrasonography or biometry demonstrating anterior-posterior elongation measurement ≥ 26 mm
* abnormal change in retinal tissue by SD-OCT that are attributed to be caused by high myopia as shown in Table 4-2 of the protocol in the investigator's discretion confirmed by the reading centre
Exclusion Criteria
* Patients showing signs of Age-Related Macular Degeneration (AMD), e.g. drusen, characteristic changes in fundus (with shaping or extension of hemorrhages, fibrosis, exudative areas) in either eye
* Acute neovascularization (CNV or iris neovascularization) and intra- or subretinal fluid in either eye at the time of enrolment.
* History of inactive CNV in study eye. Inactive CNV of fellow eye is allowed if treatment was performed more than 12 months before enrolment.
* Any anti vascular endothelial growth factor' (anti-VEGF) or Verteporfin treatment in study eye and anti-VEGF or Verteporfin treatment less than 12 months before enrolment in fellow eye
* History of systemic anti vascular endothelial growth factor' (anti-VEGF) therapy
* Cataract that would prevent an accurate measurement of the axial length of the study eye
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Regensburg, Bavaria, Germany
Novartis Investigative Site
Ansbach, , Germany
Novartis Investigative Site
Bad Rothenfelde, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Bochum, , Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Chemnitz, , Germany
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Düsseldorf, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Freiburg im Breisgau, , Germany
Novartis Investigative Site
Göttingen, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hösbach, , Germany
Novartis Investigative Site
Karlsruhe, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Mainz, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
München, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Münster, , Germany
Novartis Investigative Site
Tübingen, , Germany
Novartis Investigative Site
Würzburg, , Germany
Countries
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Related Links
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Other Identifiers
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CRFB002FDE01
Identifier Type: -
Identifier Source: org_study_id
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