Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia (BENEMCOR)

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Status and phase: Completed; Phase 3

Conditions: Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia

Treatments: Drug: Bevazizumab intravitreal injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01716026

IOBA-04-2012

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

Drug: Bevazizumab intravitreal injection

Single Dose Load Phase

Experimental group

Description:

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

Treatment:

Drug: Bevazizumab intravitreal injection