Real Life Study in Myopic Neovascularization

NCT ID: NCT03797547

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-22

Study Completion Date

2023-01-30

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.

Detailed Description

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Conditions

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Myopic Choroidal Neovascularisation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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AFLIBERCEPT

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu de Poitiers

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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VIC

Identifier Type: -

Identifier Source: org_study_id

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