EUCTR2013-004769-15-AT
Active, not recruiting
Phase 1
fMRI analysis of the visual cortex in neovascular Age-related Macular Degeneration
Medizinische Universität Wien, Universitätsklinik für Augenheilkunde0 sites41 target enrollmentNovember 19, 2013
Conditions20 patients with neovascular age-related macular degeneration will be examined before and after 3 monthly administered intravitreal ranibizumab injections according to the label with 3 tesla magnetic resonance tomography and microperimetry. 21 healthy participants serve as control group and will be examined onceTherapeutic area: Diseases [C] - Eye Diseases [C11]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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 3 tesla magnetic resonance tomography and microperimetry. 21 healthy participants serve as control group and will be examined once
- Sponsor
- Medizinische Universität Wien, Universitätsklinik für Augenheilkunde
- Enrollment
- 41
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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