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

NCT03070717 | Completed

• 1 other identifier: CRFB002FDE01
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 26

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.

Conditions

Pathologic Myopia

Keywords

High myopia, shortsightedness, retinal changes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in retinal morphology by fundus autofluorescence

  Baseline, first year, 2nd year, 3rd year

• Change in retinal morphology by fundus photography

  Baseline, first year, 2nd year, 3rd year

• Change in Best Corrected Visual Acuity (BCVA) by vision testing (Landolt chart or equivalent)

  Baseline, 3rd year

• Change in refraction error by autorefractometer

  Baseline, 3rd year

Other Outcomes (5)

• Occurence of myopic CNV at the investigator's discretion

  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

  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

  Baseline and at the date of occurence of myopic CNV at the investigator's discretion, if any, assessed up to 3 years.

Study Arms (1)

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.

Procedure: Observation & Diagnosis

Interventions

Observation & Diagnosis PROCEDURE

SD-OCT, fundus autofluorescence, fundus photography, optional microperimetry, ophthalmic exams (BCVA, optical biometry), blood sampling.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Caucasian adults with high myopia in Germany, recruited on an outpatient basis.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (26)

Novartis Investigative Site

Regensburg, Bavaria, 93053, Germany

Location

Novartis Investigative Site

Ansbach, 91522, Germany

Location

Novartis Investigative Site

Bad Rothenfelde, 49214, Germany

Location

Novartis Investigative Site

Berlin, 10713, Germany

Location

Novartis Investigative Site

Berlin, 13353, Germany

Location

Novartis Investigative Site

Bochum, 44892, Germany

Location

Novartis Investigative Site

Bonn, 53105, Germany

Location

Novartis Investigative Site

Chemnitz, 09113, Germany

Location

Novartis Investigative Site

Cologne, 50924, Germany

Location

Novartis Investigative Site

Düsseldorf, 40225, Germany

Location

Novartis Investigative Site

Essen, 45147, Germany

Location

Novartis Investigative Site

Frankfurt, 60590, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Göttingen, 37075, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Hösbach, 63768, Germany

Location

Novartis Investigative Site

Karlsruhe, 76133, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

München, 80637, Germany

Location

Novartis Investigative Site

München, 81377, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Münster, 48145, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

Related Links

• Sponsor website

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, Serum

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 3, 2017
• Study Start: June 12, 2014
• Primary Completion: May 23, 2019
• Study Completion: May 23, 2019
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

DE (26)