Real Life Study in Myopic Neovascularization

Study Overview
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Brief Summary
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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.

Official Title
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Real Life Study in Myopic Neovascularization

Conditions
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Myopic Choroidal Neovascularisation

Intervention / Treatment
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* Other: AFLIBERCEPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: AFLIBERCEPT|Patients will be treated following a real life protocol and according to the French recommendation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6, 12, 24 and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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, | 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 | 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, | 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 | 6, 12, 24 and 36 months |