H54.0
Conditions
Interventions
Group 1: Extensive data collection and evaluation of risk factors for development of a myopic CNV within high myopic patients. Diagnostics of ophthalmic disease status and relevant cofactors by imagin
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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 in the investigator’s discretion confirmed by the reading centre. -BCVA = 0.05 decimal equivalent in the study eye
Exclusion criteria
Exclusion criteria: -Use of any investigational drugs -excluding vitamins and minerals- at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer -Patients with Diabetes mellitus of any grade -Patients showing signs of AMD, e.g. drusen, characteristic changes in fundus (with shaping or extension of hemorrhages, fibrosis, exsudative 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-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-VEGF therapy -Cataract that would prevent an accurate measurement of the axial length of the study eye -Presence of active infectious disease or intra-ocular inflammation in either eye at the time of enrolment (e.g. PIC, Uveitis) -Ocular disorders that may confound interpretation of research project results, compromise visual acuity or require medical or surgical intervention during the observation period (including retinal detachment, cataract and pre-retinal membrane of the macula) -Ocular disorders which may lead to an ophthalmic surgery within 5 years -Further retinal disorders such as retinopathia pigmentosa/centralis, diabetic maculopathy or Marfan syndrome -Patients with inability to comply with the research project or follow up procedures -Research project personnel or first degree relatives of investigator(s)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and evaluate the risk factors of myopic CNV from baseline to year 1, 2 and 3 within the research project population (by SD-optical coherence tomography (OCT), autofluorescence and fundus photo). | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the pathogenesis until exit visit within the research project population and within the individual patient by: -Change in retinal morphology (annually; by SD-OCT, Fundus Autofluorescence, Fundus Photography and optional Microperimetry); -Change in BCVA (Baseline and end of study) -Change in refraction error (Baseline and end of study) -Pathogenesis related to baseline refraction error | — |
Countries
Germany
Outcome results
None listed