Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia (BENEMCOR)

Establishment of the Initial Protocol With Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Associated With High Myopia:3 vs 1.

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

Study Overview

• Status: Completed
• Conditions: Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia
• Intervention / Treatment: Drug: Bevazizumab intravitreal injection

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Albacete, Spain, 02006
    • Complejo Hospitalario de Albacete
  • Madrid, Spain, 28010
    • Hospital Clinico Universitario San Carlos
  • Madrid, Spain, 28031
    • Hospital Universitario Ramón y Cajal
  • Murcia, Spain, 30100
    • Hospital Reina Sofia
  • Sevilla, Spain, 41013
    • Hospital Virgen de Valme
  • Sevilla, Spain, 41071
    • Hospital Virgen de la Macarena
  • Valencia, Spain
    • Hospital General Universitario de Valencia
  • Valladolid, Spain, 47012
    • Hospital Universitario Río Hortega
  • Valladolid, Spain, 47011
    • IOBA - Instituto Universitario de Oftalmobiología Aplicada
  • La Coruña
    • Santiago de Compostela, La Coruña, Spain, 15706
      • CHUS - Fundacion IDICHUS
  • Navarra
    • Pamplona, Navarra, Spain, 31080
      • Clinica Universitaria de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 3 Month Load with 9 month p.r.n.; 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; Intravitreal injection of bevacizumab; Other Names: Avastin Injection
Experimental: Single Dose Load Phase; 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; Intravitreal injection of bevacizumab; Other Names: Avastin Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
• Investigators: Principal Investigator: Jose Maria Ruiz-Moreno, MD PhD, University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: choroidal neovascularization; high myopia
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Uveal Diseases; Choroid Diseases; Refractive Errors; Metaplasia; Choroidal Neovascularization; Neovascularization, Pathologic; Myopia
• Other Study ID Numbers: IOBA-04-2012