EUCTR2013-003352-20-DE
Active, not recruiting
Phase 1
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 - CAPTAI
niversity Medical Center of Johannes -Gutenberg University Mainz0 sites70 target enrollmentMay 3, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- eovascular age-related macular degeneration (AMD)
- Sponsor
- niversity Medical Center of Johannes -Gutenberg University Mainz
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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