Real Life Study in Myopic Neovascularization (VIC)

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 Overview

• Status: Active, not recruiting
• Conditions: Myopic Choroidal Neovascularisation
• Intervention / Treatment: Other: AFLIBERCEPT

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• France
  • Poitiers, France
    • CHU De Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 22, 2018
• Primary Completion (ANTICIPATED): January 30, 2023
• Study Completion (ANTICIPATED): January 30, 2023

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (ACTUAL): January 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 28, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Choroid Diseases; Refractive Errors; Metaplasia; Choroidal Neovascularization; Neovascularization, Pathologic; Myopia; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: VIC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No