20 patients with neovascular age-related macular degeneration will be examined before and after 3 monthly administered intravitreal ranibizumab injections according to the label with 7 tesla magnetic resonance tomography and microperimetry. 20 healthy participants serve as control group and will be examined once
Conditions
Interventions
Trade Name: Lucentis 10 mg/ml Injektionslösung
Product Name: Lucentis
Product Code: RFB002
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Concentr
Sponsors
Medizinische Universität Wien, Universitätsklinik für Augenheilkunde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients 50 years of age or older • ability to read • mastering the German language • signing the informed consent • (for patients): new onset, treatment naive sub-or juxtafoveal choroidal neovascularization caused by AMD • (for patients) Visual Acuity of 20/400-20/40 • (for healthy controls): Visual Acuity of 20/16- 20/30 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • (for patients): Any prior initial intravitreal treatment or previous laser treatment • (for healthy controls): presence of any retinal and/or optic nerve disease • History of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with anti-glaucoma mediation). • Aphakia or absence of the posterior capsule in the study eye. • Cataract > grade 2 (according to lens opacities system) • Amblyopia • Active intraocular inflammation (grade trace or above) in the study eye • All exclusion criteria that apply to MRI scans: Pacemaker, metal debris, metalliferous coil, claustrophobia • Pregnancy • Dyslexia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the activation pattern of the primary visual cortex in nAMD patients before and after ranibizumab therapy and to compare it with healthy controls. ;Secondary Objective: 1.Comparison of central retinal sensitivity patterns with retinotopic maps 2.Comparison of retinotopic maps of the primary visual cortex in untreated nAMD with retinotopic maps after initial ranibizumab therapy 3.Comparison of retinotopic maps of healthy controls with retinotopic maps of neovascular AMD patients 4.Evaluation of visual signal processing in nAMD compared to healthy controls 5.Correlation of absolute retinal scotoma location to associated cortical activity ;Primary end point(s): 1.Retinotopic maps of nAMD patients and healthy controls. 2.Change of the activity patterns of the primary visual cortex in nAMD patients after ranibizumab treatment ;Timepoint(s) of evaluation of this end point: progressive | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Difference of the activation patterns of the primary visual cortex in healthy controls and in nAMD patients before and after intravitreal anti-VEGF 2.Evaluation of potential plasticity of the primary visual cortex in nAMD patients 3.Comparison of retinotopic maps of healthy controls with retinotopic maps of neovascular AMD patients 4.Correlation of absolute retinal scotoma location to associated cortical activity ;Timepoint(s) of evaluation of this end point: continuous | — |
Countries
Austria
Contacts
Public ContactWiener Studien Zentrum
Universitätsklinik für Augenheilkunde, Medizinische Universität Wien
Outcome results
None listed