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

Primary Purpose

Myopia, Choroidal Neovascularization

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Intravitreal Injection
Photodynamic Therapy (Visudyne)
Sponsored by
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring High Myopia, Bevacizumab, Photodynamic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • INGO
  • Hospital General Reina Sofía
  • Clínica Universitaria de Navarra
  • Instituto Oftalmológico de Alicante
  • Hospital de la Vall d´Hebron
  • Hospital Clínico San Carlos
  • IOBA - Instituto Universitario de Oftalmobiología Aplicada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intravitreal Bevacizumab

Visudyne

Arm Description

Intravitreal injections of bevacizumab

Photodynamic Therapy with Visudyne

Outcomes

Primary Outcome Measures

Improvement in Visual Acuity assessed by ETDRS

Secondary Outcome Measures

Central macular thickness with Ocular Coherence Tomography
Complications that may arise from intravitreal injection

Full Information

First Posted
August 24, 2009
Last Updated
March 18, 2014
Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborators
Fondo de Investigacion Sanitaria
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1. Study Identification

Unique Protocol Identification Number
NCT00967850
Brief Title
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

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
Collaborators
Fondo de Investigacion Sanitaria

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Choroidal Neovascularization
Keywords
High Myopia, Bevacizumab, Photodynamic therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal Bevacizumab
Arm Type
Experimental
Arm Description
Intravitreal injections of bevacizumab
Arm Title
Visudyne
Arm Type
Active Comparator
Arm Description
Photodynamic Therapy with Visudyne
Intervention Type
Drug
Intervention Name(s)
Intravitreal Injection
Other Intervention Name(s)
Avastin
Intervention Description
Intravitreal injection of 1,25 mg in 0,05 ml
Intervention Type
Drug
Intervention Name(s)
Photodynamic Therapy (Visudyne)
Intervention Description
Photodynamic therapy on day 1 as described in standard clinical guidelines.
Primary Outcome Measure Information:
Title
Improvement in Visual Acuity assessed by ETDRS
Time Frame
Every month during first year - Every three months during the second year
Secondary Outcome Measure Information:
Title
Central macular thickness with Ocular Coherence Tomography
Time Frame
Every month during first year - Every three months during the second year
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Carlos Pastor Jimeno, MD, PhD
Organizational Affiliation
IOBA - Instituto Universitario de Oftalmobiología Aplicada
Official's Role
Principal Investigator
Facility Information:
Facility Name
INGO
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital General Reina Sofía
City
Espinardo
State/Province
Murcia
ZIP/Postal Code
30100
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31080
Country
Spain
Facility Name
Instituto Oftalmológico de Alicante
City
Alicante
ZIP/Postal Code
03015
Country
Spain
Facility Name
Hospital de la Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28010
Country
Spain
Facility Name
IOBA - Instituto Universitario de Oftalmobiología Aplicada
City
Valladolid
ZIP/Postal Code
47011
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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