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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada Identifier:
First received: October 25, 2012
Last updated: June 23, 2015
Last verified: June 2015
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

Condition Intervention Phase
Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia
Drug: Bevazizumab intravitreal injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Establishment of the Initial Protocol With Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Associated With High Myopia:3 vs 1.

Resource links provided by NLM:

Further study details as provided by Instituto Universitario de Oftalmobiología Aplicada:

Primary Outcome Measures:
  • Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit

  • Retinal thickness [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Retinal thickness assessed by Spectral Domain Optical Coherence Tomography

  • Number of total injections during study [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Total count of bevacizumab intravitreal injections during the whole study

Estimated Enrollment: 110
Study Start Date: October 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Avastin Injection


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01716026

CHUS - Fundacion IDICHUS
Santiago de Compostela, La Coruña, Spain, 15706
Clinica Universitaria de Navarra
Pamplona, Navarra, Spain, 31080
Complejo Hospitalario de Albacete
Albacete, Spain, 02006
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28031
Hospital Clinico Universitario San Carlos
Madrid, Spain, 28010
Hospital Reina Sofia
Murcia, Spain, 30100
Hospital Virgen de Valme
Sevilla, Spain, 41013
Hospital Virgen de la Macarena
Sevilla, Spain, 41071
Hospital General Universitario de Valencia
Valencia, Spain
Hospital Universitario Rio Hortega
Valladolid, Spain, 47012
IOBA - Instituto Universitario de Oftalmobiologia Aplicada
Valladolid, Spain, 47011
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada
Principal Investigator: Jose Maria Ruiz-Moreno, MD PhD University of Castilla-La Mancha
  More Information

Responsible Party: Instituto Universitario de Oftalmobiología Aplicada Identifier: NCT01716026     History of Changes
Other Study ID Numbers: IOBA-04-2012 
Study First Received: October 25, 2012
Last Updated: June 23, 2015
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Instituto Universitario de Oftalmobiología Aplicada:
high myopia
choroidal neovascularization

Additional relevant MeSH terms:
Choroidal Neovascularization
Neovascularization, Pathologic
Choroid Diseases
Eye Diseases
Pathologic Processes
Refractive Errors
Uveal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Physiological Effects of Drugs processed this record on May 26, 2016