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

Pathologic Myopia Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03070717
• Other study ID #: CRFB002FDE01
• Status: Completed
• Start date: June 12, 2014
• Est. completion date: May 23, 2019

Study information

• Verified date: July 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 23, 2019
• Est. primary completion date: May 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Myopia
• Neovascularization, Pathologic
• Pathologic Myopia

Intervention

Procedure:
• Observation & Diagnosis
SD-OCT, fundus autofluorescence, fundus photography, optional microperimetry, ophthalmic exams (BCVA, optical biometry), blood sampling.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Ansbach
Germany	Novartis Investigative Site	Bad Rothenfelde
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Gottingen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hösbach
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Regensburg	Bavaria
Germany	Novartis Investigative Site	Tuebingen
Germany	Novartis Investigative Site	Wuerzburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurence of myopic CNV at the investigator's discretion	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.
Other	Change in health related quality of life (QoL) by NEI-VFQ-25 questionnaire	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).
Other	Assessment of biomarkers by analyzing blood samples	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.
Other	Assessment of genetic factors by analyzing blood samples	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.
Other	Change in axial length of the bulbus by optical biometry	To assess the change in axial length of the bulbus in both eyes by optical biometry.	Baseline, first year, 2nd year, 3rd year
Primary	Change in retinal morphology by SD-OCT	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	Change in retinal morphology by fundus autofluorescence	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
Secondary	Change in retinal morphology by fundus photography	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
Secondary	Change in Best Corrected Visual Acuity (BCVA) by vision testing (Landolt chart or equivalent)	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
Secondary	Change in refraction error by autorefractometer	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