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

This study is currently recruiting participants.
Verified October 2012 by Instituto Universitario de Oftalmobiología Aplicada
Sponsor:
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier:
NCT01716026
First received: October 25, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

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:

Drug Information available for: Bevacizumab
U.S. FDA Resources

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: December 2013
Estimated Primary Completion Date: December 2013 (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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716026

Contacts
Contact: Jose Maria Ruiz-Moreno, MD, PhD 610435999 jm.ruiz@umh.es
Contact: Maria Isabel Lopez-Galvez, MD, PhD 34 983184734 maribel@ioba.med.uva.es

Locations
Spain
CHUS - Fundacion IDICHUS Recruiting
Santiago de Compostela, La Coruña, Spain, 15706
Principal Investigator: Ramon Gomez-Ulla, MD PhD            
Clinica Universitaria de Navarra Recruiting
Pamplona, Navarra, Spain, 31080
Principal Investigator: Alfredo Garcia Layana, MD PhD            
Complejo Hospitalario de Albacete Recruiting
Albacete, Spain, 02006
Principal Investigator: Jose Maria Ruiz-Moreno, MD PhD            
Hospital Clinico Universitario San Carlos Recruiting
Madrid, Spain, 28010
Principal Investigator: Juan Donate, MD PhD            
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28031
Principal Investigator: Marta Suarez de Figueroa, MD PhD            
Hospital Reina Sofia Recruiting
Murcia, Spain, 30100
Principal Investigator: Inmaculada Selles, MD PhD            
Hospital Virgen de Valme Recruiting
Sevilla, Spain, 41013
Principal Investigator: Antonio Piñero Bustamante, MD PhD            
Hospital Virgen de la Macarena Recruiting
Sevilla, Spain, 41071
Principal Investigator: Eduardo Esteban, Gonzalez            
Hospital General Universitario de Valencia Recruiting
Valencia, Spain
Principal Investigator: Enrique Cervera Taulet, MD PhD            
IOBA - Instituto Universitario de Oftalmobiologia Aplicada Recruiting
Valladolid, Spain, 47011
Principal Investigator: Maria Isabel Lopez-Galvez, MD PhD            
Hospital Universitario Rio Hortega Recruiting
Valladolid, Spain, 47012
Principal Investigator: Javier Montero Moreno, MD PhD            
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada
Investigators
Principal Investigator: Jose Maria Ruiz-Moreno, MD PhD University of Castilla-La Mancha
  More Information

No publications provided

Responsible Party: Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier: NCT01716026     History of Changes
Other Study ID Numbers: IOBA-04-2012
Study First Received: October 25, 2012
Last Updated: October 25, 2012
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:
Myopia
Neovascularization, Pathologic
Choroidal Neovascularization
Refractive Errors
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
 Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013