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

NCT00967850 | Completed Phase 3

• 2 other identifiers: IOBA-002-2007EUDRA CT 2007-006785-15
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 7

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.

Conditions

Myopia; Choroidal Neovascularization

Keywords

High Myopia; Bevacizumab; Photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• Improvement in Visual Acuity assessed by ETDRS

  Every month during first year - Every three months during the second year

Secondary Outcomes (2)

• 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

Study Arms (2)

Intravitreal Bevacizumab

EXPERIMENTAL

Intravitreal injections of bevacizumab

Drug: Intravitreal Injection

Visudyne

ACTIVE COMPARATOR

Photodynamic Therapy with Visudyne

Drug: Photodynamic Therapy (Visudyne)

Interventions

Intravitreal Injection DRUG

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

Also known as: Avastin

Intravitreal Bevacizumab

Photodynamic Therapy (Visudyne) DRUG

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

Visudyne

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at least 18 years old
• High Myopia with one of the following:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA: lead
• Fondo de Investigacion Sanitaria: collaborator

Study Sites (7)

INGO

Santiago de Compostela, La Coruña, 15706, Spain

Location

Hospital General Reina Sofía

Espinardo, Murcia, 30100, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, 31080, Spain

Location

Instituto Oftalmológico de Alicante

Alicante, 03015, Spain

Location

Hospital de la Vall d´Hebron

Barcelona, 08022, Spain

Location

Hospital Clínico San Carlos

Madrid, 28010, Spain

Location

IOBA - Instituto Universitario de Oftalmobiología Aplicada

Valladolid, 47011, Spain

Location

MeSH Terms

Conditions

Myopia; Choroidal Neovascularization

Interventions

Intravitreal Injections; Bevacizumab; Photochemotherapy; Verteporfin

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Combined Modality Therapy; Phototherapy; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• José Carlos Pastor Jimeno, MD, PhD

  IOBA - Instituto Universitario de Oftalmobiología Aplicada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 28, 2009
• Study Start: April 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 31, 2024

Record last verified: 2009-08

Locations

ES (7)