choroidal neovascularization associated to myopia magna MedDRA version: 14.1 Level: LLT Classification code 10060837 Term: Choroidal neovascularization System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Avastin® 25 mg/ml
Product Name: Avastin® 25 mg/ml
Product Code: 650602
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
C
Sponsors
IOBA, Universidad de Valladolid
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-Myopic patients over 18 years with active subfoveal choroidal neovascularisation associated to yuxtafoveolar myopia confirmed by AGF and OCT. 2-Patients with loss of visual acuity less than 6 months lenght caused by the neovascular lesion at the discretion of the researcher. 3-Lesions in which the presence of atrophic or fibrotic component does not prevent vision improvement . 4-4-Patients with active subfoveal and yuxtafoveolar choroidal neovascularization associated with myopia magna previously treated with photodynamic therapy. 5-Informed written consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1-Previous surgery vitrectomy. 2-tractional maculopathy and/or idiopathic epiretinal membrane diagnosed by OCT. 3-media opacity that does not allow to adequately assess the fundus of the eye. 4-Lack of integrity of the posterior lens capsule in pseudophakia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1-Best Corrected Visual Acuity: measured by the ETDRS rules with best correction possible.;Timepoint(s) of evaluation of this end point: every 30 days;Main Objective: Determine whether the use of an intravitreal injection of Bevacizumab (Avastin ®) followed by PRN allows for comparable improvement (not different) in the Best Corrected Visual Acuity against the use of three consecutive monthly injections followed by PRN, as treatment of subfoveal choroidal neovascularization and yuxtafoveolar in pathologic myopia.;Secondary Objective: 1-Determine whether the use of an intravitreal injection of Bevacizumab (Avastin ®) followed by PRN allows a comparable thickening retina decrease (not different) at the fovea against the use of three consecutive monthly injections followed by PRN, as treatment and subfoveal choroidal neovascularization in yuxtafoveolarpathologic myopia. 2-Determine whether the use of an intravitreal injection of Bevacizumab (Avastin ®) followed by PRN allows a smaller number of injections needed to control the disease versus the use of three consecutive monthly injections followed by PRN, as treatment of subfoveal choroidal neovascularization and yuxtafoveolar in pathologic myopia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2-Retinal Thickness: measured by spectral domain OCT 3-Number of intravitreal injections needed.;Timepoint(s) of evaluation of this end point: Retinal thickness will be evaluated every 30 days. Number of injections will be evaluated at the end of the study. | — |
Countries
Spain
Contacts
Public ContactMarian Quevedo
IOBA, Universidad de Valladolid
Outcome results
None listed