UnknownNot Applicable

Real Life Study in Myopic Neovascularization

France24 participantsStarted 2018-06-22

Plain-language 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. This sudy aims to evaluate the visual acuity during a 36 months period of time.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

visual acuity measurement

Timeframe: 6, 12, 24 and 36 months

Trial details

NCT IDNCT03797547

SponsorPoitiers University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-30

View on ClinicalTrials.gov More Myopic Choroidal Neovascularisation trials