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Completed

NCT Number: NCT03070717

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

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.

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Key information

Conditions

Pathologic Myopia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Regensburg, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observation & Diagnosis

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Acronym: HELP

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2017
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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