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

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

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.

Study Overview

• Status: Completed
• Conditions: Choroidal Neovascularization; Myopia
• Intervention / Treatment: Drug: Intravitreal Injection; Drug: Photodynamic Therapy (Visudyne)

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
• Enrollment (Actual): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03015
    • Instituto Oftalmológico de Alicante
  • Barcelona, Spain, 08022
    • Hospital de la Vall d´Hebron
  • Madrid, Spain, 28010
    • Hospital Clinico San Carlos
  • Valladolid, Spain, 47011
    • IOBA - Instituto Universitario de Oftalmobiología Aplicada
  • La Coruña
    • Santiago de Compostela, La Coruña, Spain, 15706
      • INGO
  • Murcia
    • Espinardo, Murcia, Spain, 30100
      • Hospital General Reina Sofía
  • Navarra
    • Pamplona, Navarra, Spain, 31080
      • Clinica Universitaria de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in Visual Acuity assessed by ETDRS	Every month during first year - Every three months during the second year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Collaborators: Fondo de Investigacion Sanitaria
• Investigators: Principal Investigator: José Carlos Pastor Jimeno, MD, PhD, IOBA - Instituto Universitario de Oftalmobiología Aplicada

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: August 24, 2009
• First Submitted That Met QC Criteria: August 27, 2009
• First Posted (Estimated): August 28, 2009

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Bevacizumab; Photodynamic therapy; High Myopia
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Refractive Errors; Uveal Diseases; Choroid Diseases; Metaplasia; Myopia; Choroidal Neovascularization; Neovascularization, Pathologic; Dermatologic Agents; Photosensitizing Agents; Verteporfin
• Other Study ID Numbers: IOBA-002-2007; EUDRA CT 2007-006785-15