Efficacy of Aflibercept (Eylea®) on Choroidal Neovascularization (Type 3)

NCT ID: NCT02320474

Last Updated: 2019-03-08

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-25

Study Completion Date

2018-11-30

Brief Summary

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This is a one-year pilot, interventional, prospective, single arm, non-randomized, multicentric (3 centers) controlled study that aims to evaluate the response of type 3 choroidal neovascularization to treatment by Aflibercept following a classic protocol.

Detailed Description

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Conditions

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Type 3 Choroidal Neovascularization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aflibercept

Group Type EXPERIMENTAL

Aflibercept

Intervention Type DRUG

Interventions

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Aflibercept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males or females aged more than 50 years
* Patients with type 3 choroidal neovascularization assessed on FA, ICG and OCT
* Exudation on SD-OCT scans defined by intraretinal cysts or subretinal fluid.
* Best Corrected Visual Acuity at inclusion between 24 and 78 letters (ETDRS)
* Media clarity, pupillary dilation and patient cooperation sufficient to allow fundus photographs of adequate quality

Exclusion Criteria

* Any contraindications as reported in the labelling of Aflibercept (Eylea®): Ocular or periocular infection, Active intraocular inflammation or Hypersensitivity.
* Any previous history of intravitreal injections in the study eye for exudative AMD
* Any secondary chorioretinal anastomosis due to retinal scar or fibrosis
* Any history of vitrectomy
* Media opacities preventing accurate imaging of the retina (cataract)
* Any other retinal disorder possibly associated with type 3 CNV (epiretinal membrane, macular hole)
* Confirmed intraocular pressure ≥25 mmHg or non-stable glaucoma.
Minimum Eligible Age

50 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

Principal Investigators

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Nicolas LEVEZIEL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Poitiers

Locations

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Poitiers University Hospital

Poitiers, , France

Site Status

Polyclinic of POITIERS

Poitiers, , France

Site Status

Countries

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France

Other Identifiers

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ATTRACT

Identifier Type: -

Identifier Source: org_study_id

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