Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia

NCT01716026 | Completed Phase 3

• 1 other identifier: IOBA-04-2012
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this protocol is to determine wether the initial protocol in the treatment of subfoveal choroidal neovascularization associated to High Myopia with bevacizumab intravitreal injections is more effective when using 3 doses vs using 1 single dose in the load period

Conditions

Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia

Keywords

high myopia; choroidal neovascularization

Outcome Measures

Primary Outcomes (3)

• Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity

  Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit

  1 Year

• Retinal thickness

  Retinal thickness assessed by Spectral Domain Optical Coherence Tomography

  1 Year

• Number of total injections during study

  Total count of bevacizumab intravitreal injections during the whole study

  1 Year

Study Arms (2)

3 Month Load with 9 month p.r.n.

ACTIVE COMPARATOR

3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit

Drug: Bevazizumab intravitreal injection

Single Dose Load Phase

EXPERIMENTAL

Single dose treatment with bevacizumab, followed by 2 sham injections if conditions are met in the months 2 and 3, and followed with bevacizumab monthly p.r.n. as per protocol

Drug: Bevazizumab intravitreal injection

Interventions

Bevazizumab intravitreal injection DRUG

Intravitreal injection of bevacizumab

Also known as: Avastin Injection

3 Month Load with 9 month p.r.n.; Single Dose Load Phase

Eligibility Criteria

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

You may qualify if:

• Active subfoveal/juxtafoveal choroidal neovascularization in high myopia confirmed by Fundus Fluorescein angiography and Optical Coherence Tomography
• Best corrected visual acuity loss with less than 6 months of evolution, caused mainly by the neovascular lesion (based in investigator´s criteria)
• No atrophy or fibrotic component that may prevent visual acuity improvement
• Patients previously treated with Photodynamic Therapy are allowed to participate in this study
• Signed informed consent
• Signed data protection consent
• Negative pregnancy test in potential childbearing women at screening, with accepted contraceptive method during the whole study

You may not qualify if:

• Previous vitreous surgery in study eye
• Tractional maculopathy or epiretinal membrane found in Optical Coherence Tomography
• Media opacities that may prevent correct fundus assessment
• Lack of posterior capsule integrity in pseudophakic patients
• Patients with great possibilities of not being able to attend to study visits / follow visit procedures (investigator´s criteria)
• Patients previously treated with intravitreal antiangiogenic injections

Sponsors & Collaborators

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

Study Sites (11)

CHUS - Fundacion IDICHUS

Santiago de Compostela, La Coruña, 15706, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31080, Spain

Location

Complejo Hospitalario de Albacete

Albacete, 02006, Spain

Location

Hospital Clinico Universitario San Carlos

Madrid, 28010, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28031, Spain

Location

Hospital Reina Sofia

Murcia, 30100, Spain

Location

Hospital Virgen de Valme

Seville, 41013, Spain

Location

Hospital Virgen de la Macarena

Seville, 41071, Spain

Location

Hospital General Universitario de Valencia

Valencia, Spain

Location

IOBA - Instituto Universitario de Oftalmobiologia Aplicada

Valladolid, 47011, Spain

Location

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

Location

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jose Maria Ruiz-Moreno, MD PhD

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2012
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 13, 2023

Record last verified: 2021-06

Locations

ES (11)