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

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

Tracking Information

• First Submitted Date: February 17, 2016
• First Posted Date: March 3, 2017
• Last Update Posted Date: July 19, 2019
• Actual Study Start Date: June 12, 2014
• Actual Primary Completion Date: May 23, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 28, 2017)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 28, 2017)

• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: February 28, 2017)

• 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.
• 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.
• 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.
• 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.
• 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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: High Myopia: Extended and Longterm Observation of Pathologic Myopia Patients With the Risk for Developing a Myopic Choroidal Neovascularization (CNV)
• Official Title: High Myopia: Extended and Longterm Observation of Pathologic Myopia Patients With the Risk for Developing a Myopic Choroidal Neovascularization (CNV)
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Whole blood, Serum

• Sampling Method: Non-Probability Sample
• Study Population: Caucasian adults with high myopia in Germany, recruited on an outpatient basis.
• Condition: Pathologic Myopia

Intervention

Procedure: Observation & Diagnosis

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

Study Groups/Cohorts

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.

Intervention: Procedure: Observation & Diagnosis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 28, 2017): 153
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 23, 2019
• Actual Primary Completion Date: May 23, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT03070717
• Other Study ID Numbers: CRFB002FDE01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Study Sponsor: Novartis Pharmaceuticals
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Novartis
• Verification Date: July 2019