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

Primary Purpose

Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Bevazizumab intravitreal injection
Sponsored by
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia focused on measuring high myopia, choroidal neovascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHUS - Fundacion IDICHUS
  • Clinica Universitaria de Navarra
  • Complejo Hospitalario de Albacete
  • Hospital Clinico Universitario San Carlos
  • Hospital Universitario Ramón y Cajal
  • Hospital Reina Sofia
  • Hospital Virgen de Valme
  • Hospital Virgen de la Macarena
  • Hospital General Universitario de Valencia
  • IOBA - Instituto Universitario de Oftalmobiologia Aplicada
  • Hospital Universitario Rio Hortega

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

3 Month Load with 9 month p.r.n.

Single Dose Load Phase

Arm Description

3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit

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

Outcomes

Primary Outcome Measures

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
Retinal thickness
Retinal thickness assessed by Spectral Domain Optical Coherence Tomography
Number of total injections during study
Total count of bevacizumab intravitreal injections during the whole study

Secondary Outcome Measures

Full Information

First Posted
October 25, 2012
Last Updated
March 10, 2023
Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
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1. Study Identification

Unique Protocol Identification Number
NCT01716026
Brief Title
Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia
Acronym
BENEMCOR
Official Title
Establishment of the Initial Protocol With Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Associated With High Myopia:3 vs 1.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 2012 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia
Keywords
high myopia, choroidal neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3 Month Load with 9 month p.r.n.
Arm Type
Active Comparator
Arm Description
3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit
Arm Title
Single Dose Load Phase
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bevazizumab intravitreal injection
Other Intervention Name(s)
Avastin Injection
Intervention Description
Intravitreal injection of bevacizumab
Primary Outcome Measure Information:
Title
Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity
Description
Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit
Time Frame
1 Year
Title
Retinal thickness
Description
Retinal thickness assessed by Spectral Domain Optical Coherence Tomography
Time Frame
1 Year
Title
Number of total injections during study
Description
Total count of bevacizumab intravitreal injections during the whole study
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Maria Ruiz-Moreno, MD PhD
Organizational Affiliation
University of Castilla-La Mancha
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUS - Fundacion IDICHUS
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31080
Country
Spain
Facility Name
Complejo Hospitalario de Albacete
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos
City
Madrid
ZIP/Postal Code
28010
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Reina Sofia
City
Murcia
ZIP/Postal Code
30100
Country
Spain
Facility Name
Hospital Virgen de Valme
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
IOBA - Instituto Universitario de Oftalmobiologia Aplicada
City
Valladolid
ZIP/Postal Code
47011
Country
Spain
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain

12. IPD Sharing Statement

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Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia

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