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

Completed

• Conditions: Pathologic Myopia
• Interventions: Procedure: Observation & Diagnosis

• Registration Number: NCT03070717
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-12
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Primary Completion: 2019-05-23
• Study Completion: 2019-05-23
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	Observation & Diagnosis	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.

Primary Outcome Measures

Name	Time	Method
Change in retinal morphology by SD-OCT	Baseline, first year, 2nd year, 3rd year	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.

Secondary Outcome Measures

Name	Time	Method
Change in retinal morphology by fundus autofluorescence	Baseline, first year, 2nd year, 3rd year	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.
Change in retinal morphology by fundus photography	Baseline, first year, 2nd year, 3rd year	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.
Change in refraction error by autorefractometer	Baseline, 3rd year	To exploratively determine the pathogenesis within the project population and within the individual patient by change of refraction error from baseline to 3rd year.
Change in Best Corrected Visual Acuity (BCVA) by vision testing (Landolt chart or equivalent)	Baseline, 3rd year	To exploratively determine the pathogenesis within the project population and within the individual patient by change of BCVA from baseline to 3rd year.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Wuerzburg, Germany