High myopia: extended and longterm observation of pathologic myopia patients with the risk for developing a myopic CNV.

Not Applicable

• Conditions: H54.0; Blindness, binocular

• Registration Number: DRKS00007761
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-12
• Study Completion: 2019-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 152

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

-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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To determine the pathogenesis until exit visit within the research project population and within the individual patient by:<br><br>-Change in retinal morphology (annually; by SD-OCT, Fundus Autofluorescence, Fundus Photography and optional Microperimetry);<br>-Change in BCVA (Baseline and end of study)<br>-Change in refraction error (Baseline and end of study)<br>-Pathogenesis related to baseline refraction error