Myopic Choroidal NeovascularisationVICNCT03797547
Real Life Study in Myopic Neovascularization
An observational study of Myopic Choroidal Neovascularisation, run by Poitiers University Hospital at 1 site in France.
Trial summary
This is a multi centre, single arm, prospective observational phase 4 study in naive or pretreated patients with myopic neovascularization. The patients will be treated with intravitreal injections of Aflibercept following a real life protocol. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myopic Choroidal Neovascularisation
- What is being tested?
- AFLIBERCEPT
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2018to 30 Jan 2023
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Active mCNV among: * Naïve patients. * Patients with previous history of laser photocoagulation or PDT, with no history of anti-VEGF. * Patients with previous history of other anti-VEGF treatments.including ranibizumab or bevacizumab, with sustaining mCNV activity, who did not receive injection since the last 3 month
Who may be able to join
- Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potenteial (hormonal or any intrauterine devices).
- High myopy defined by refractive error ≤ -6 D or History of high myopia among pseudophakic patient or patient treated with refractive surgery
- Patient with active CNVm
- • Patients naïve or Patients pretreated with previous history of laser photocoagulation or PDT or by other anti-VEGF treatments who did not receive injection since the last 3 month
- with OCT or angiography examination
Who cannot join
- Treatment with an anti VEGF administrated by intravitreal injection within 1 months prior to baseline in the study eye.
- Treatment with PDT or laser administrated within 6 months prior to baseline in the study eye.
- History of vitrectomy in the study eye
- History of any other retinal disease
- VA less than 20/250
Trial locations and contacts
1 site in 1 country.
About this study
This is a multi centre, single arm, prospective observational phase 4 study in naive or pretreated patients with myopic neovascularization. The patients will be treated with intravitreal injections of Aflibercept following a real life protocol.
This sudy aims to evaluate the visual acuity during a 36 months period of time.
- Conditions
- Myopic Choroidal Neovascularisation
- Being tested
- AFLIBERCEPT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFLIBERCEPTOther
Patients will be treated following a real life protocol and according to the French recommendation
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity measurement
Efficacy measurement will be performed by mean change of "ETDRS" for Best Corrected Visual Acuity evaluation (ETDRS score at 4 meters) from baseline to 6, 12, 24 and 36 month after initation of treatment by aflibercept
Measured: 6, 12, 24 and 36 months
Secondary outcomes (6)
visual acuity measurement in naive patient
Efficacy measurement will be performed by mean change of "ETDRS" for Best corrected visual acuity evaluation from baseline to month 12, 24 and 36 after initation of treatment by aflibercept in naïve patients
Measured: 12, 24 and 36 months
visual acuity measurement after other treatment such as laser, pdt visudyneor other IVT treatment
Efficacy measurement will be evaluated by mean change of "ETDRS" for Best corrected visual Acuity evaluation after initation of treatment by aflibercept after switch from other treatment such as laser, visudyne PDT or other IVT treatment, after 6, 12, 24 and 36 months of treatment with Eylea
Measured: 6, 12, 24 and 36 months
pourcentage of patients who gain more than or equal of 15 letters
Efficacy measurement will be evaluated by pourcentage of patients who gain more than or equal of 15 letters at 6, 12, 24 and 36 months after initiation of treatment with aflibercept within naïve or after switch from other treatment such as laser, visudyne PDT or other IVT treatment,
Measured: 6,12,24 and 36 months
Anatomics parameters by oct
Evaluation of anatomic parameters will be perfomed after 6,12, and 24 and 36 months of treatment with Eylea based on OCT parameters :
On SD-OCT :
Distance from CNV lesion to the fovea measured on the scan joining the fovea to the foveal edge of the mCNV Exudation assessed by presence of intraretinal cysts or subretinal fluid Central retinal thickness
Measured: 6, 12, 24 and 36 months
Anatomics parameters by color photographs
On color retinal photographs:
Presence of retinal hemorrhage Presence of macular atrophy or lacquer cracks,
Measured: 6, 12, 24 and 36 months
Anatomic parameters by fluoresceine angiography or angiography oct
On fluoresceine angiography if deemed necessary by the investigator : diffusion during late phases On angiography OCT : neovascular network visualisation
Measured: 6, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start22 Jun 2018
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopic Choroidal NeovascularisationStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797547
- Sponsor's protocol ID
- VIC
- Acronym
- VIC
- Status last verified
- Sep 2021
- First submitted
- 28 Aug 2018
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Study in Myopic Neovascularization
- ClinicalTrials.gov ID
- NCT03797547
- Acronym / sponsor ID
- VIC / VIC
- Conditions
- Myopic Choroidal Neovascularisation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 9 Jan 2019 (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 is a multi centre, single arm, prospective observational phase 4 study in naive or pretreated patients with myopic neovascularization. The patients will be treated with intravitreal injections of Aflibercept following a real life protocol.
This sudy aims to evaluate the visual acuity during a 36 months period of time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Active mCNV among: * Naïve patients. * Patients with previous history of laser photocoagulation or PDT, with no history of anti-VEGF. * Patients with previous history of other anti-VEGF treatments.including ranibizumab or bevacizumab, with sustaining mCNV activity, who did not receive injection since the last 3 month
Key inclusion criteria (5 listed)
- Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potenteial (hormonal or any intrauterine devices).
- High myopy defined by refractive error ≤ -6 D or History of high myopia among pseudophakic patient or patient treated with refractive surgery
- Patient with active CNVm
- • Patients naïve or Patients pretreated with previous history of laser photocoagulation or PDT or by other anti-VEGF treatments who did not receive injection since the last 3 month
Key exclusion criteria (5 listed)
- Treatment with an anti VEGF administrated by intravitreal injection within 1 months prior to baseline in the study eye.
- Treatment with PDT or laser administrated within 6 months prior to baseline in the study eye.
- History of vitrectomy in the study eye
- History of any other retinal disease
- VA less than 20/250
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 |
|---|---|---|
| AFLIBERCEPTPatients will be treated following a real life protocol and according to the French recommendation | Other | – |
Primary outcome
visual acuity measurement
Time frame: 6, 12, 24 and 36 months
Efficacy measurement will be performed by mean change of "ETDRS" for Best Corrected Visual Acuity evaluation (ETDRS score at 4 meters) from baseline to 6, 12, 24 and 36 month after initation of treatment by aflibercept
6 secondary outcomes
visual acuity measurement in naive patient
Time frame: 12, 24 and 36 months
visual acuity measurement after other treatment such as laser, pdt visudyneor other IVT treatment
Time frame: 6, 12, 24 and 36 months
pourcentage of patients who gain more than or equal of 15 letters
Time frame: 6,12,24 and 36 months
Anatomics parameters by oct
Time frame: 6, 12, 24 and 36 months
Anatomics parameters by color photographs
Time frame: 6, 12, 24 and 36 months
Anatomic parameters by fluoresceine angiography or angiography oct
Time frame: 6, 12, 24 and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopic Choroidal Neovascularisation, run by Poitiers University Hospital at 1 site in France.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
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?
visual acuity measurement (time frame: 6, 12, 24 and 36 months). 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 29 Sep 2021.