Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia

Study Overview
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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

Official Title
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Establishment of the Initial Protocol With Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Associated With High Myopia:3 vs 1.

Conditions
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Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia

Intervention / Treatment
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* Drug: Bevazizumab intravitreal injection


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3 Month Load with 9 month p.r.n.<br>3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit | Drug: Bevazizumab intravitreal injection<br>* Intravitreal injection of bevacizumab<br>* Other names: Avastin Injection;|
| Experimental: Single Dose Load Phase<br>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 | Drug: Bevazizumab intravitreal injection<br>* Intravitreal injection of bevacizumab<br>* Other names: Avastin Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity | Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit | 1 Year | 
| Retinal thickness | Retinal thickness assessed by Spectral Domain Optical Coherence Tomography | 1 Year | 
| Number of total injections during study | Total count of bevacizumab intravitreal injections during the whole study | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high myopia, choroidal neovascularization