Activity patterns of the cortical optic area in wet age-related macular degeneration patients

Conditions: 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
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2012-004758-27-AT

Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Augenheilkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

•(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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>2.Comparison of retinotopic maps of the primary visual cortex in untreated nAMD with retinotopic maps after initial ranibizumab therapy<br>3.Comparison of retinotopic maps of healthy controls with retinotopic maps of neovascular AMD patients<br>4.Evaluation of visual signal processing in nAMD compared to healthy controls<br>5.Correlation of absolute retinal scotoma location to associated cortical activity<br><br>;Primary end point(s): 1.Retinotopic maps of nAMD patients and healthy controls. <br>2.Change of the activity patterns of the primary visual cortex in nAMD patients after ranibizumab treatment<br>;Timepoint(s) of evaluation of this end point: progressive

Secondary Outcome Measures

Name	Time	Method
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<br>2.Evaluation of potential plasticity of the primary visual cortex in nAMD patients<br>3.Comparison of retinotopic maps of healthy controls with retinotopic maps of neovascular AMD patients<br>4.Correlation of absolute retinal scotoma location to associated cortical activity<br>;Timepoint(s) of evaluation of this end point: continuous