High Myopia: Extended and Longterm Observation of Pathologic Myopia Patients With the Risk for Developing a Myopic Choroidal Neovascularization (CNV)

Study Overview
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Brief Summary
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This research project intends to observe patients with high myopia who show pathological retinal changes, in order to evaluate more data on the risk factors for developing mCNV within this research project population in Germany.

Official Title
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High Myopia: Extended and Longterm Observation of Pathologic Myopia Patients With the Risk for Developing a Myopic Choroidal Neovascularization (CNV)

Conditions
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Pathologic Myopia

Intervention / Treatment
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* Procedure: Observation & Diagnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female caucasian patients ≥ 18 years of age 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 with Diabetes mellitus of any grade 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 Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>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. | Procedure: Observation & Diagnosis<br>* SD-OCT, fundus autofluorescence, fundus photography, optional microperimetry, ophthalmic exams (BCVA, optical biometry), blood sampling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in retinal morphology by SD-OCT | To exploratively determine the pathogenesis within the project population by assessing and evaluating the risk factors of myopic CNV by measuring the change in retinal morphology with spectral domain optical coherence tomography (SD-OCT). Risk factors are defined as choroidal thinning < 50μm, choroidal curvature length > 6300 μm (nasal temporal), lacquer cracks, patchy atrophy > 5mm² and preexisting myopic CNV in second eye. | Baseline, first year, 2nd year, 3rd year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in retinal morphology by fundus autofluorescence | To exploratively determine the pathogenesis within the project population by assessing and evaluating the risk factors of myopic CNV within the project population by measuring the change in retinal morphology with fundus autofluorescence. Risk factors are defined as choroidal thinning < 50μm, choroidal curvature length > 6300 μm (nasal temporal), lacquer cracks, patchy atrophy > 5mm² and preexisting myopic CNV in second eye. | Baseline, first year, 2nd year, 3rd year | 
| Change in retinal morphology by fundus photography | To exploratively determine the pathogenesis within the project population by assessing and evaluating the risk factors of myopic CNV within the project population by measuring the change in retinal morphology with fundus photography. Risk factors are defined as choroidal thinning < 50μm, choroidal curvature length > 6300 μm (nasal temporal), lacquer cracks, patchy atrophy > 5mm² and preexisting myopic CNV in second eye. | Baseline, first year, 2nd year, 3rd year | 
| Change in Best Corrected Visual Acuity (BCVA) by vision testing (Landolt chart or equivalent) | To exploratively determine the pathogenesis within the project population and within the individual patient by change of BCVA from baseline to 3rd year. | Baseline, 3rd year | 
| Change in refraction error by autorefractometer | To exploratively determine the pathogenesis within the project population and within the individual patient by change of refraction error from baseline to 3rd year. | Baseline, 3rd year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High myopia, shortsightedness, retinal changes