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

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ClinicalTrials.gov Identifier: NCT03070717
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment
Pathologic Myopia Procedure: Observation & Diagnosis

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Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Myopia: Extended and Longterm Observation of Pathologic Myopia Patients With the Risk for Developing a Myopic Choroidal Neovascularization (CNV)
Actual Study Start Date : June 12, 2014
Actual Primary Completion Date : May 23, 2019
Actual Study Completion Date : May 23, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   Samples With DNA
Whole blood, Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Caucasian adults with high myopia in Germany, recruited on an outpatient basis.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070717


Locations
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Germany
Novartis Investigative Site
Regensburg, Bavaria, Germany, 93053
Novartis Investigative Site
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, 48145
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
München, Germany, 80637
Novartis Investigative Site
Tuebingen, Germany, 72076
Novartis Investigative Site
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03070717    
Other Study ID Numbers: CRFB002FDE01
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
High myopia, shortsightedness, retinal changes
Additional relevant MeSH terms:
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Myopia
Choroidal Neovascularization
Neovascularization, Pathologic
Refractive Errors
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases