Pathologic MyopiaHELPNCT03070717
High Myopia: Extended and Longterm Observation of Pathologic Myopia Patients With the Risk for Developing a Myopic Choroidal Neovascularization (CNV)
An observational study of Pathologic Myopia, run by Novartis Pharmaceuticals at 26 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pathologic Myopia
- What is being tested?
- Observation & Diagnosis
- Type of treatment
- Surgery or procedure
- How many people
- 153 participants
- Where
- 26 sitesGermany
- Study dates
- 12 Jun 2014to 23 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Caucasian adults with high myopia in Germany, recruited on an outpatient basis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Germany26 sites
Novartis Investigative Site
Ansbach, 91522
Novartis Investigative Site
Bad Rothenfelde, 49214
Novartis Investigative Site
Berlin, 10713
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Bochum, 44892
Novartis Investigative Site
Bonn, 53105
Novartis Investigative Site
Chemnitz, 09113
Novartis Investigative Site
Cologne, 50924
Novartis Investigative Site
Düsseldorf, 40225
Novartis Investigative Site
Essen, 45147
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hösbach, 63768
Novartis Investigative Site
Karlsruhe, 76133
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
München, 80637
Novartis Investigative Site
München, 81377
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Münster, 48145
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Regensburg, Bavaria, 93053
Novartis Investigative Site
Tübingen, 72076
Novartis Investigative Site
Würzburg, 97080
About this study
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.
- Conditions
- Pathologic Myopia
- Being tested
- Observation & Diagnosis
- Keywords
- High myopia, shortsightedness, retinal changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation & DiagnosisProcedure or surgery
SD-OCT, fundus autofluorescence, fundus photography, optional microperimetry, ophthalmic exams (BCVA, optical biometry), blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Observation & Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, first year, 2nd year, 3rd year
Secondary outcomes (4)
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.
Measured: Baseline, first year, 2nd year, 3rd year
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.
Measured: Baseline, first year, 2nd year, 3rd year
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.
Measured: Baseline, 3rd year
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.
Measured: Baseline, 3rd year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start12 Jun 2014
- Primary completion23 May 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathologic MyopiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070717
- Sponsor's protocol ID
- CRFB002FDE01
- Acronym
- HELP
- Status last verified
- Jul 2019
- First submitted
- 17 Feb 2016
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Myopia: Extended and Longterm Observation of Pathologic Myopia Patients With the Risk for Developing a Myopic Choroidal Neovascularization (CNV)
- ClinicalTrials.gov ID
- NCT03070717
- Acronym / sponsor ID
- HELP / CRFB002FDE01
- Conditions
- Pathologic Myopia
- Keywords
- High myopia, shortsightedness, retinal changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2014 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Procedure: Observation & DiagnosisPatients with diagnosis of high myopia secondary to an anterior-posterior elongation of the bulbus confirmed by ocular examination in either eye using specific criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caucasian adults with high myopia in Germany, recruited on an outpatient basis.
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation & DiagnosisSD-OCT, fundus autofluorescence, fundus photography, optional microperimetry, ophthalmic exams (BCVA, optical biometry), blood sampling. | Procedure or surgery | All patients |
Primary outcome
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.
4 secondary outcomes
Change in retinal morphology by fundus autofluorescence
Time frame: Baseline, first year, 2nd year, 3rd year
Change in retinal morphology by fundus photography
Time frame: Baseline, first year, 2nd year, 3rd year
Change in Best Corrected Visual Acuity (BCVA) by vision testing (Landolt chart or equivalent)
Time frame: Baseline, 3rd year
Change in refraction error by autorefractometer
Time frame: Baseline, 3rd year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Sponsor websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pathologic Myopia, run by Novartis Pharmaceuticals at 26 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in retinal morphology by SD-OCT (time frame: Baseline, first year, 2nd year, 3rd year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.