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

Phase 1

• 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; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2013-004769-15-AT
• Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Augenheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-19
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 41

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