Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia

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

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to determine the efficacy and safety of intravitreal injections of bevacizumab in High Myopia´s choroidal neovascularization versus the standard treatment of Photodynamic therapy.

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Detailed Description

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Bad response in choroidal neovascularization in High myopia to Photodynamic therapy, which is the current approved treatment for that pathology, and the high incidence of this pathology in these patients, together with the great functional impact in their vision has fostered the search for new therapeutic strategies.

Intravitreal bevacizumab has already been tested in small series of patients with choroidal neovascularization associated to high myopia, whether as first treatment option or after the failure of photodynamic therapy with good results. In the published series an improvement of visual acuity is described after 1-2 injections, with a reduction in the macular edema and a good safety profile.

The lack of published trials that describe the efficacy of frequency of treatment in this pathology is the main reason for this trial.

Conditions

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Myopia Choroidal Neovascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intravitreal Bevacizumab

Intravitreal injections of bevacizumab

Group Type EXPERIMENTAL

Intravitreal Injection

Intervention Type DRUG

Intravitreal injection of 1,25 mg in 0,05 ml

Visudyne

Photodynamic Therapy with Visudyne

Group Type ACTIVE_COMPARATOR

Photodynamic Therapy (Visudyne)

Intervention Type DRUG

Photodynamic therapy on day 1 as described in standard clinical guidelines.

Interventions

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Intravitreal Injection

Intravitreal injection of 1,25 mg in 0,05 ml

Intervention Type DRUG

Photodynamic Therapy (Visudyne)

Photodynamic therapy on day 1 as described in standard clinical guidelines.

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

* Patient at least 18 years old
* High Myopia with one of the following:

* 6 or more sphere diopters in the study eye
* Axial length of the eye greater than 26 millimeters
* Active subfoveal/juxtafoveal choroidal neovascularization confirmed by Fluorescein angiography and Ocular coherence tomography.
* Visual acuity loss of less than 6 months of evolution related to the neovascular lesion, as stated by investigator´s opinion.
* Patients previously treated with Photodynamic therapy are allowed to participate as long as the last treatment has been performed more than 3 months upon entering the study.
* Signed informed consent.
* Signed data protection consent.
* Women of childbearing potential must provide a negative pregnancy test at inclusion and must commit to the use of a contraceptive treatment during the whole study.

Exclusion Criteria

* Previous vitrectomy surgery in the study eye.
* Tractional maculopathy and/or epiretinal membrane evaluated by Ocular coherence tomography.
* Opacities that may not allow correct fundus assessment.
* Lack of integrity of the posterior lens capsule in pseudoaphakic patients.
* Patients that may not want/be able to complete the study, based in the investigator opinion.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No