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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03070717

Collaborator

(none)

153

Enrollment

Locations

59.3

Actual Duration (Months)

5.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Pathologic Myopia	Procedure: Observation & Diagnosis

Study Design

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 :

Jun 12, 2014

Actual Primary Completion Date :

May 23, 2019

Actual Study Completion Date :

May 23, 2019

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Change in retinal morphology by SD-OCT [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

Change in retinal morphology by fundus autofluorescence [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 [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) [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 [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

Occurence of myopic CNV at the investigator's discretion [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 [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 [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 [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 [Baseline, first year, 2nd year, 3rd year]
To assess the change in axial length of the bulbus in both eyes by optical biometry.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Regensburg	Bavaria	Germany	93053
2	Novartis Investigative Site	Ansbach		Germany	91522
3	Novartis Investigative Site	Bad Rothenfelde		Germany	49214
4	Novartis Investigative Site	Berlin		Germany	10713
5	Novartis Investigative Site	Berlin		Germany	13353
6	Novartis Investigative Site	Bochum		Germany	44892
7	Novartis Investigative Site	Bonn		Germany	53105
8	Novartis Investigative Site	Chemnitz		Germany	09113
9	Novartis Investigative Site	Duesseldorf		Germany	40225
10	Novartis Investigative Site	Essen		Germany	45147
11	Novartis Investigative Site	Frankfurt		Germany	60590
12	Novartis Investigative Site	Freiburg		Germany	79106
13	Novartis Investigative Site	Gottingen		Germany	37075
14	Novartis Investigative Site	Hamburg		Germany	20246
15	Novartis Investigative Site	Hösbach		Germany	63768
16	Novartis Investigative Site	Karlsruhe		Germany	76133
17	Novartis Investigative Site	Koeln		Germany	50924
18	Novartis Investigative Site	Leipzig		Germany	04103
19	Novartis Investigative Site	Mainz		Germany	55131
20	Novartis Investigative Site	Muenchen		Germany	81377
21	Novartis Investigative Site	Muenchen		Germany	81675
22	Novartis Investigative Site	Muenster		Germany	48145
23	Novartis Investigative Site	Muenster		Germany	48149
24	Novartis Investigative Site	München		Germany	80637
25	Novartis Investigative Site	Tuebingen		Germany	72076
26	Novartis Investigative Site	Wuerzburg		Germany	97080

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novartis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03070717

Other Study ID Numbers:

CRFB002FDE01

First Posted:

Mar 3, 2017

Last Update Posted:

Jul 19, 2019

Last Verified:

Jul 1, 2019

Keywords provided by Novartis Pharmaceuticals

High myopia, shortsightedness, retinal changes

Additional relevant MeSH terms:

Myopia

Choroidal Neovascularization

Neovascularization, Pathologic

Study Results

No Results Posted as of Jul 19, 2019