Correlation of functional and structural outcomes with serum antibody profiles in patients with neovascular age-related macular degeneration treated with ranibizumab and healthy subjects: a prospective, controlled monocenter trial

Phase 1

Conditions: eovascular age-related macular degeneration (AMD)
MedDRA version: 19.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2013-003352-20-DE

Lead Sponsor: niversity Medical Center of Johannes -Gutenberg University Mainz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

Main inclusion criteria (patients):
Subjects meeting all of the following criteria will be considered for enrolment to the trial:
-Male or female
-Age = 50 years
-Subfoveal, juxtafoveal and/or extrafoveal choroidal neovascularisation due to neovascular age-related macular degeneration
-Visual acuity of 20/400 or better in the study eye
Main inclusion criteria (healthy volunteers):
-Male or female
-Age = 50 years

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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Main exclusion criteria (patients):
Subjects presenting 1 of the following criteria will not be enrolled in the trial:
-Inability to obtain fluorescein angiography
-Ophthalmic surgery or laser <3 months before enrolment in one or both eyes
-Any history of intravitreal steroids
-Systemic and/or intravitreal anti-VEGF-treatment or ocular laser < 3 months before enrolment in one or both eyes
-Patients with hypersensitivity against ranibizumab
-Inability to give informed consent to participate in the study (legal representative is accepted)
-Pregnancy, lactation or women who are of childbearing age and not using medically
acceptable effective contraception.
Main exclusion criteria (healthy volunteers):
Subjects presenting 1 of the following criteria will not be enrolled in the trial:
-Relevant eye diseases except age-related cataract in one or both eyes
-Ophthalmic surgery or laser <3 months before enrolment in one or both eyes