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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01716026
First Posted: October 29, 2012
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit

  • Retinal thickness [ Time Frame: 1 Year ]
    Retinal thickness assessed by Spectral Domain Optical Coherence Tomography

  • Number of total injections during study [ Time Frame: 1 Year ]
    Total count of bevacizumab intravitreal injections during the whole study


Estimated Enrollment: 110
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716026


Locations
Spain
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 Clinico Universitario San Carlos
Madrid, Spain, 28010
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28031
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
IOBA - Instituto Universitario de Oftalmobiologia Aplicada
Valladolid, Spain, 47011
Hospital Universitario Rio Hortega
Valladolid, Spain, 47012
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada
Investigators
Principal Investigator: Jose Maria Ruiz-Moreno, MD PhD University of Castilla-La Mancha
  More Information

Responsible Party: Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier: NCT01716026     History of Changes
Other Study ID Numbers: IOBA-04-2012
First Submitted: October 25, 2012
First Posted: October 29, 2012
Last Update Posted: March 28, 2017
Last Verified: March 2017

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
Growth Inhibitors
Antineoplastic Agents