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Completed

NCT Number: NCT00967850

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

INGO, Santiago de Compostela, La Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravitreal injection

Drug

Intravitreal injection of 1,25 mg in 0,05 ml

Other names: Avastin

Photodynamic Therapy (Visudyne)

Drug

Photodynamic therapy on day 1 as described in standard clinical guidelines.

Primary outcomes

  1. Improvement in Visual Acuity assessed by ETDRS

    Time frame: Every month during first year - Every three months during the second year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

Other

Collaborators

  • Fondo de Investigacion Sanitaria

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 28, 2009
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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