Real Life Study in Myopic Neovascularization

Poitiers University Hospital24 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Myopic Choroidal Neovascularisation

Interventions

AFLIBERCEPTOTHER

Patients will be treated following a real life protocol and according to the French recommendation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Chu de Poitiers

Poitiers, France

Outcomes

Primary Outcomes

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

Time frame: 6, 12, 24 and 36 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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,

Time frame: 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

Data from ClinicalTrials.gov

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