Initial Treatment With Bevacizumab in Choroidal Neovascularization 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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-04-30

Brief Summary

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The purpose of this protocol is to determine wether the initial protocol in the treatment of subfoveal choroidal neovascularization associated to High Myopia with bevacizumab intravitreal injections is more effective when using 3 doses vs using 1 single dose in the load period

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Detailed Description

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Conditions

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Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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3 Month Load with 9 month p.r.n.

3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit

Group Type ACTIVE_COMPARATOR

Bevazizumab intravitreal injection

Intervention Type DRUG

Intravitreal injection of bevacizumab

Single Dose Load Phase

Single dose treatment with bevacizumab, followed by 2 sham injections if conditions are met in the months 2 and 3, and followed with bevacizumab monthly p.r.n. as per protocol

Group Type EXPERIMENTAL

Bevazizumab intravitreal injection

Intervention Type DRUG

Intravitreal injection of bevacizumab

Interventions

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Bevazizumab intravitreal injection

Intravitreal injection of bevacizumab

Intervention Type DRUG

Other Intervention Names

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Avastin Injection

Eligibility Criteria

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Inclusion Criteria

* Active subfoveal/juxtafoveal choroidal neovascularization in high myopia confirmed by Fundus Fluorescein angiography and Optical Coherence Tomography
* Best corrected visual acuity loss with less than 6 months of evolution, caused mainly by the neovascular lesion (based in investigator´s criteria)
* No atrophy or fibrotic component that may prevent visual acuity improvement
* Patients previously treated with Photodynamic Therapy are allowed to participate in this study
* Signed informed consent
* Signed data protection consent
* Negative pregnancy test in potential childbearing women at screening, with accepted contraceptive method during the whole study

Exclusion Criteria

* Previous vitreous surgery in study eye
* Tractional maculopathy or epiretinal membrane found in Optical Coherence Tomography
* Media opacities that may prevent correct fundus assessment
* Lack of posterior capsule integrity in pseudophakic patients
* Patients with great possibilities of not being able to attend to study visits / follow visit procedures (investigator´s criteria)
* Patients previously treated with intravitreal antiangiogenic injections

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No