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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967850
• Other study ID #: IOBA-002-2007
• Secondary ID: EUDRA CT 2007-00
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2009
• Last updated: March 18, 2014
• Start date: April 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2009
• Source: Instituto Universitario de Oftalmobiología Aplicada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Myopia
• Neovascularization, Pathologic

Intervention

Drug:
• Intravitreal Injection
Intravitreal injection of 1,25 mg in 0,05 ml
• Photodynamic Therapy (Visudyne)
Photodynamic therapy on day 1 as described in standard clinical guidelines.

Locations

Country	Name	City	State
Spain	Instituto Oftalmológico de Alicante	Alicante
Spain	Hospital de la Vall d´Hebron	Barcelona
Spain	Hospital General Reina Sofía	Espinardo	Murcia
Spain	Hospital Clínico San Carlos	Madrid
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	INGO	Santiago de Compostela	La Coruña
Spain	IOBA - Instituto Universitario de Oftalmobiología Aplicada	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Universitario de Oftalmobiología Aplicada	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Visual Acuity assessed by ETDRS		Every month during first year - Every three months during the second year	No
Secondary	Central macular thickness with Ocular Coherence Tomography		Every month during first year - Every three months during the second year	No
Secondary	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	Yes