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

This study has been completed.
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier:
NCT00967850
First received: August 24, 2009
Last updated: March 18, 2014
Last verified: August 2009
  Purpose

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 Intervention Phase
Myopia
Choroidal Neovascularization
Drug: Intravitreal Injection
Drug: Photodynamic Therapy (Visudyne)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Instituto Universitario de Oftalmobiología Aplicada:

Primary Outcome Measures:
  • Improvement in Visual Acuity assessed by ETDRS [ Time Frame: Every month during first year - Every three months during the second year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Central macular thickness with Ocular Coherence Tomography [ Time Frame: Every month during first year - Every three months during the second year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 56
Study Start Date: April 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967850

Locations
Spain
INGO
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
Investigators
Principal Investigator: José Carlos Pastor Jimeno, MD, PhD IOBA - Instituto Universitario de Oftalmobiología Aplicada
  More Information

No publications provided

Responsible Party: Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier: NCT00967850     History of Changes
Other Study ID Numbers: IOBA-002-2007, EUDRA CT 2007-006785-15
Study First Received: August 24, 2009
Last Updated: March 18, 2014
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Choroidal Neovascularization
Myopia
Neovascularization, Pathologic
Choroid Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Refractive Errors
Uveal Diseases
Bevacizumab
Verteporfin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Dermatologic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014