Clinical trial NCT03070717: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pathologic Myopia
Keywords: High myopia, shortsightedness, retinal changes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-03-03
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caucasian adults with high myopia in Germany, recruited on an outpatient basis.

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.


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

Primary outcomes:
measure: Change in retinal morphology by SD-OCT
timeFrame: Baseline, first year, 2nd year, 3rd year
Secondary outcomes:
measure: Change in retinal morphology by fundus autofluorescence
timeFrame: Baseline, first year, 2nd year, 3rd year
measure: Change in retinal morphology by fundus photography
timeFrame: Baseline, first year, 2nd year, 3rd year
measure: Change in Best Corrected Visual Acuity (BCVA) by vision testing (Landolt chart or equivalent)
timeFrame: Baseline, 3rd year
measure: Change in refraction error by autorefractometer
timeFrame: Baseline, 3rd year
Other outcomes:
measure: Occurence of myopic CNV at the investigator's discretion
timeFrame: From baseline until the date of occurence of myopic CNV at the investigator's discretion (if any), assessed up to 3 years.
measure: Change in health related quality of life (QoL) by NEI-VFQ-25 questionnaire
timeFrame: 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).
measure: Assessment of biomarkers by analyzing blood samples
timeFrame: Baseline and at the date of occurence of myopic CNV at the investigator's discretion, if any, assessed up to 3 years.
measure: Assessment of genetic factors by analyzing blood samples
timeFrame: Baseline and at the date of occurence of myopic CNV at the investigator's discretion, if any, assessed up to 3 years.
measure: Change in axial length of the bulbus by optical biometry
timeFrame: Baseline, first year, 2nd year, 3rd year
Locations:
city: Regensburg
country: Germany
facility: Novartis Investigative Site
state: Bavaria
city: Ansbach
country: Germany
facility: Novartis Investigative Site
city: Bad Rothenfelde
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Gottingen
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hösbach
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Koeln
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Wuerzburg
country: Germany
facility: Novartis Investigative Site
Study officials:
References: