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Assessment of Visual Acuity in Patients With Polypoidal Choroidal Vasculopathy and Aflibercept Treatment

NCT ID: NCT02381730

Last Updated: 2017-12-08

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

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-08-31

Brief Summary

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Polypoidal choroidal vasculopathy (PCV) is a disease of the choroidal vasculature, that is often regarded as a sub-type of age-related macular degeneration (AMD). However, PCV response to anti-vascular agents differs from the response of typical AMD.

This study aims at describing the evolution of the best corrected visual acuity (BCVA) in PCV patients, 28 weeks after they receive one injection of intravitreal aflibercept (2mg).

Detailed Description

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Conditions

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Polypoidal Choroidal Vasculopathy

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

Intravitreal aflibercept

Intervention Type DRUG

Patient receive one intravitreal injection of 2mg aflibercept (as currently recommended in the treatment of AMD)

Interventions

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Intravitreal aflibercept

Patient receive one intravitreal injection of 2mg aflibercept (as currently recommended in the treatment of AMD)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Active polypoidal choroidal vasculopathy,
* Visual acuity superior to 1/10 (20/200) and inferior to 6,25/10 (20/32)
* Age above 45
* No prior intravitreal treatment, or no response to prior treatment by 3 injections of ranibizumab, or disease recurrence after more than 3 months of stability
* Intravitreal injection of aflibercept is indicated by current clinical recommendations

Exclusion Criteria

* Simultaneous treatment with another anti-VEGM agent
* Diabetic retinopathy
* Personal history of vitrectomy or uveitis
* Personal history laser photocoagulation and/or verteporphin phototherapy
* Tear in the pigmentary epithelium
* Chorioretinitis scar
* Macular atrophy in the pigmentary epithelium
* Treatment with corticosteroids
* Eye surgery less than 3 months before inclusion
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martine Mauget-Faysse

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique A. de Rothschild

Locations

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CHU Lyon Croix Rousse

Lyon, , France

Site Status

Fondation Ophtalmologique A. de Rothschild

Paris, , France

Site Status

Centre Médical de la Rétine Maison Rouge

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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2013-A01717-38

Identifier Type: -

Identifier Source: org_study_id