Choroidal Subfoveal/Juxtafoveal Neovascularization in High Myopia Clinical Trial
— BENEMCOROfficial title:
Establishment of the Initial Protocol With Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization Associated With High Myopia:3 vs 1.
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
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | April 2018 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Complejo Hospitalario de Albacete | Albacete | |
| Spain | Hospital Clinico Universitario San Carlos | Madrid | |
| Spain | Hospital Universitario Ramón y Cajal | Madrid | |
| Spain | Hospital Reina Sofia | Murcia | |
| Spain | Clinica Universitaria de Navarra | Pamplona | Navarra |
| Spain | CHUS - Fundacion IDICHUS | Santiago de Compostela | La Coruña |
| Spain | Hospital Virgen de la Macarena | Sevilla | |
| Spain | Hospital Virgen de Valme | Sevilla | |
| Spain | Hospital General Universitario de Valencia | Valencia | |
| Spain | Hospital Universitario Rio Hortega | Valladolid | |
| Spain | IOBA - Instituto Universitario de Oftalmobiologia Aplicada | Valladolid |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 1 Year | |
| Primary | Retinal thickness | Retinal thickness assessed by Spectral Domain Optical Coherence Tomography | 1 Year | |
| Primary | Number of total injections during study | Total count of bevacizumab intravitreal injections during the whole study | 1 Year |