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

July 18, 2019 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ansbach, Germany, 91522
        • Novartis Investigative Site
      • Bad Rothenfelde, Germany, 49214
        • Novartis Investigative Site
      • Berlin, Germany, 10713
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Bochum, Germany, 44892
        • Novartis Investigative Site
      • Bonn, Germany, 53105
        • Novartis Investigative Site
      • Chemnitz, Germany, 09113
        • Novartis Investigative Site
      • Duesseldorf, Germany, 40225
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Gottingen, Germany, 37075
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Novartis Investigative Site
      • Hösbach, Germany, 63768
        • Novartis Investigative Site
      • Karlsruhe, Germany, 76133
        • Novartis Investigative Site
      • Koeln, Germany, 50924
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Muenchen, Germany, 81377
        • Novartis Investigative Site
      • Muenchen, Germany, 81675
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site
      • Muenster, Germany, 48145
        • Novartis Investigative Site
      • München, Germany, 80637
        • Novartis Investigative Site
      • Tuebingen, Germany, 72076
        • Novartis Investigative Site
      • Wuerzburg, Germany, 97080
        • Novartis Investigative Site
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
SD-OCT, fundus autofluorescence, fundus photography, optional microperimetry, ophthalmic exams (BCVA, optical biometry), blood sampling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in retinal morphology by SD-OCT
Time Frame: 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.
Baseline, first year, 2nd year, 3rd year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in retinal morphology by fundus autofluorescence
Time Frame: 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.
Baseline, first year, 2nd year, 3rd year
Change in retinal morphology by fundus photography
Time Frame: 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.
Baseline, first year, 2nd year, 3rd year
Change in Best Corrected Visual Acuity (BCVA) by vision testing (Landolt chart or equivalent)
Time Frame: 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.
Baseline, 3rd year
Change in refraction error by autorefractometer
Time Frame: 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.
Baseline, 3rd year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of myopic CNV at the investigator's discretion
Time Frame: From baseline until the date of occurence of myopic CNV at the investigator's discretion (if any), assessed up to 3 years.
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
Time Frame: 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).
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
Time Frame: Baseline and at the date of occurence of myopic CNV at the investigator's discretion, if any, assessed up to 3 years.
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
Time Frame: Baseline and at the date of occurence of myopic CNV at the investigator's discretion, if any, assessed up to 3 years.
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
Time Frame: Baseline, first year, 2nd year, 3rd year
To assess the change in axial length of the bulbus in both eyes by optical biometry.
Baseline, first year, 2nd year, 3rd year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2014

Primary Completion (Actual)

May 23, 2019

Study Completion (Actual)

May 23, 2019

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 28, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002FDE01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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