Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation & Diagnosis | Procedure | SD-OCT, fundus autofluorescence, fundus photography, optional microperimetry, ophthalmic exams (BCVA, optical biometry), blood sampling. |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of myopic CNV at the investigator's discretion | To assess if myopic CNV in study eye and/or fellow eye occured from baseline to 3rd year. | From baseline until the date of occurence of myopic CNV at the investigator's discretion (if any), assessed up to 3 years. |
| Change in health related quality of life (QoL) by NEI-VFQ-25 questionnaire |
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:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Caucasian adults with high myopia in Germany, recruited on an outpatient basis.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Regensburg | Bavaria | 93053 | Germany | ||
| Novartis Investigative Site |
Not provided
| Label | URL |
|---|---|
| Sponsor website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Whole blood, Serum
| 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 |
To assess the change in health related QoL by patient reported outcome with the VFQ-25 questionnaire. |
| Baseline and 3rd year (or at the date of occurence of myopic CNV at the investigator's discretion, if any, whichever comes first, assessed up to 3 years). |
| Assessment of biomarkers by analyzing blood samples | To assess biomarkers which are possibly related to mCNV development. Blood samples will be taken at baseline from all patients who gave separate informed consents. A second sample will only be taken at CNV occurence (if any), assessed up to 3 years. Inflammatory and angiogenic markers will be measured and checked for the potential association to CNV formation. | Baseline and at the date of occurence of myopic CNV at the investigator's discretion, if any, assessed up to 3 years. |
| Assessment of genetic factors by analyzing blood samples | To assess genetic factors which are possibly related to mCNV development. Blood samples will be taken at baseline from all patients who gave separate informed consents. A second sample will only be taken at CNV occurence (if any), assessed up to 3 years. Inflammatory and angiogenic markers will be measured and checked for the potential association to CNV formation. | Baseline and at the date of occurence of myopic CNV at the investigator's discretion, if any, assessed up to 3 years. |
| Change in axial length of the bulbus by optical biometry | To assess the change in axial length of the bulbus in both eyes by optical biometry. | Baseline, first year, 2nd year, 3rd year |
| Ansbach |
| 91522 |
| Germany |
| Novartis Investigative Site | Bad Rothenfelde | 49214 | Germany |
| Novartis Investigative Site | Berlin | 10713 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Bochum | 44892 | Germany |
| Novartis Investigative Site | Bonn | 53105 | Germany |
| Novartis Investigative Site | Chemnitz | 09113 | Germany |
| Novartis Investigative Site | Cologne | 50924 | Germany |
| Novartis Investigative Site | Düsseldorf | 40225 | Germany |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Frankfurt | 60590 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Hösbach | 63768 | Germany |
| Novartis Investigative Site | Karlsruhe | 76133 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | München | 80637 | Germany |
| Novartis Investigative Site | München | 81377 | Germany |
| Novartis Investigative Site | München | 81675 | Germany |
| Novartis Investigative Site | Münster | 48145 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided