Clinical trial NCT00967850: Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia
Official title: Phase III Study of Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myopia
Choroidal Neovascularization
Keywords: High Myopia
Bevacizumab
Photodynamic therapy
Lead sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2009-08-28
Enrollment: 56
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 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Visual Acuity assessed by ETDRS
timeFrame: Every month during first year - Every three months during the second year
Secondary outcomes:
measure: Central macular thickness with Ocular Coherence Tomography
timeFrame: Every month during first year - Every three months during the second year
measure: Complications that may arise from intravitreal injection
timeFrame: Every treatment visit - Once per month during the first 3 months. Reteatments depending on Visual acuitiy evolution and retinal thickness
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: INGO
state: La Coruña
city: Espinardo
country: Spain
facility: Hospital General Reina Sofía
state: Murcia
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
state: Navarra
city: Alicante
country: Spain
facility: Instituto Oftalmológico de Alicante
city: Barcelona
country: Spain
facility: Hospital de la Vall d´Hebron
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Valladolid
country: Spain
facility: IOBA - Instituto Universitario de Oftalmobiología Aplicada
Study officials:
affiliation: IOBA - Instituto Universitario de Oftalmobiología Aplicada
name: José Carlos Pastor Jimeno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: