Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00967850
Recruitment Status : Completed
First Posted : August 28, 2009
Last Update Posted : March 19, 2014
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada

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.

Condition or disease Intervention/treatment Phase
Myopia Choroidal Neovascularization Drug: Intravitreal Injection Drug: Photodynamic Therapy (Visudyne) Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Efficacy and Safety of Intravitreal Bevacizumab in the Treatment of Choroidal Neovascular Membranes Associated to High Myopia
Study Start Date : April 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intravitreal Bevacizumab
Intravitreal injections of bevacizumab
Drug: Intravitreal Injection
Intravitreal injection of 1,25 mg in 0,05 ml
Other Name: Avastin
Active Comparator: Visudyne
Photodynamic Therapy with Visudyne
Drug: Photodynamic Therapy (Visudyne)
Photodynamic therapy on day 1 as described in standard clinical guidelines.

Primary Outcome Measures :
  1. Improvement in Visual Acuity assessed by ETDRS [ Time Frame: Every month during first year - Every three months during the second year ]

Secondary Outcome Measures :
  1. Central macular thickness with Ocular Coherence Tomography [ Time Frame: Every month during first year - Every three months during the second year ]
  2. Complications that may arise from intravitreal injection [ Time Frame: Every treatment visit - Once per month during the first 3 months. Reteatments depending on Visual acuitiy evolution and retinal thickness ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00967850

Santiago de Compostela, La Coruña, Spain, 15706
Hospital General Reina Sofía
Espinardo, Murcia, Spain, 30100
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31080
Instituto Oftalmológico de Alicante
Alicante, Spain, 03015
Hospital de la Vall d´Hebron
Barcelona, Spain, 08022
Hospital Clínico San Carlos
Madrid, Spain, 28010
IOBA - Instituto Universitario de Oftalmobiología Aplicada
Valladolid, Spain, 47011
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada
Fondo de Investigacion Sanitaria
Principal Investigator: José Carlos Pastor Jimeno, MD, PhD IOBA - Instituto Universitario de Oftalmobiología Aplicada

Responsible Party: Instituto Universitario de Oftalmobiología Aplicada Identifier: NCT00967850     History of Changes
Other Study ID Numbers: IOBA-002-2007
EUDRA CT 2007-006785-15
First Posted: August 28, 2009    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: August 2009

Keywords provided by Instituto Universitario de Oftalmobiología Aplicada:
High Myopia
Photodynamic therapy

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Neovascularization
Refractive Errors
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases
Retinal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents