Clinical trial NCT01716026: Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia
Official title: Establishment of the Initial Protocol With Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Associated With High Myopia:3 vs 1.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia
Keywords: high myopia
choroidal neovascularization
Lead sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Sponsor class: OTHER
First posted: 2012-10-29
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity
timeFrame: 1 Year
measure: Retinal thickness
timeFrame: 1 Year
measure: Number of total injections during study
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: CHUS - Fundacion IDICHUS
state: La Coruña
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Albacete
country: Spain
facility: Complejo Hospitalario de Albacete
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Murcia
country: Spain
facility: Hospital Reina Sofia
city: Sevilla
country: Spain
facility: Hospital Virgen de Valme
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valladolid
country: Spain
facility: IOBA - Instituto Universitario de Oftalmobiologia Aplicada
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
Study officials:
affiliation: University of Castilla-La Mancha
name: Jose Maria Ruiz-Moreno, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: