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

I

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

Status and phase

Completed
Phase 3

Conditions

Choroidal Neovascularization
Myopia

Treatments

Drug: Photodynamic Therapy (Visudyne)
Drug: Intravitreal Injection

Study type

Interventional

Funder types

Other

Identifiers

NCT00967850
IOBA-002-2007
EUDRA CT 2007-006785-15

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

56 participants in 2 patient groups

Intravitreal Bevacizumab
Experimental group
Description:
Intravitreal injections of bevacizumab
Treatment:
Drug: Intravitreal Injection
Visudyne
Active Comparator group
Description:
Photodynamic Therapy with Visudyne
Treatment:
Drug: Photodynamic Therapy (Visudyne)

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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