Initial Treatment With Bevacizumab in Choroidal Neovascularization Associated to High Myopia

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01716026

Acronym

BENEMCOR

Enrollment

Registered

2012-10-29

Start date

2012-10-31

Completion date

2018-04-30

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia

Keywords

high myopia, choroidal neovascularization

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

Interventions

DRUGBevazizumab intravitreal injection

Intravitreal injection of bevacizumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity	1 Year	Differences in best corrected visual acuity in the exit visit compared to the one obtained at screening visit
Retinal thickness	1 Year	Retinal thickness assessed by Spectral Domain Optical Coherence Tomography
Number of total injections during study	1 Year	Total count of bevacizumab intravitreal injections during the whole study

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026