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OpenTrials
Completed

NCT Number: NCT01716026

Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia

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

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Key information

Conditions

Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHUS - Fundacion IDICHUS, Santiago de Compostela, La Coruña, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevazizumab intravitreal injection

Drug

Intravitreal injection of bevacizumab

Other names: Avastin Injection

Primary outcomes

  1. 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

  2. Retinal thickness

    Time frame: 1 Year

    Retinal thickness assessed by Spectral Domain Optical Coherence Tomography

  3. Number of total injections during study

    Time frame: 1 Year

    Total count of bevacizumab intravitreal injections during the whole study

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: BENEMCOR

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Oct 29, 2012
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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