This trial is active, not recruiting.

Condition choroidal subfoveal/juxtafoveal neovascularization in high myopia
Treatment bevazizumab intravitreal injection
Phase phase 3
Sponsor Instituto Universitario de Oftalmobiología Aplicada
Start date October 2012
End date December 2015
Trial size 110 participants
Trial identifier NCT01716026, IOBA-04-2012


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
3 Monthly bevacizumab injections with 9 p.r.n. monthly doses if patient meets the treatment criteria for each monthly visit
bevazizumab intravitreal injection Avastin Injection
Intravitreal injection of bevacizumab
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
bevazizumab intravitreal injection Avastin Injection
Intravitreal injection of bevacizumab

Primary Outcomes

Early Treatment Diabetic Retinopathy Study (ETDRS) Best corrected visual acuity
time frame: 1 Year
Retinal thickness
time frame: 1 Year
Number of total injections during study
time frame: 1 Year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Establishment of the Initial Protocol With Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Associated With High Myopia:3 vs 1.
Principal investigator Jose Maria Ruiz-Moreno, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Instituto Universitario de Oftalmobiología Aplicada.