Neovascular age-related macular degeneration (AMD) MedDRA version: 19.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Lucentis® (Ranibizumab, Novartis Pharma GmbH)
Product Name: Lucentis 10mg/ml
Pharmaceutical Form: Solution for injection
Sponsors
University Medical Center of Johannes -Gutenberg University Mainz
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy (change in BCVA) of IVT administered ranibizumab in subjects with all subtypes of neovascular AMD.;Secondary Objective: • To assess the efficacy (change in central retinal thickness as measured by OCT) of IVT administered ranibizumab in subjects with all subtypes of neovascular AMD. • To identify antibodies (biomarkers) against retinal antigens in patients with neovascular AMD treated with ranibizumab and healthy subjects. • To validate antibodies (biomarkers) against retinal antigens in patients with neovascular AMD treated with ranibizumab and healthy subjects found in previous studies. • To correlate functional and structural parameters (BCVA and central retinal thickness) with the identified biomarkers to differentiate between initial and deferred responders. ;Primary end point(s): Change from Baseline (Visit 1) in BCVA score at Week 12 (visit 4) in the study eye. Initial responders will be differentiated from deferred responders.;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: Change from Baseline (Visit 1) in BCVA score at Week 24 (visit 7) in the study eye. Initial responders will be differentiated from deferred responders. Absolute change from baseline (Visit 1) in central retinal thickness, assessed by OCT at Week 24 (Visit 7) in the study eye. Mean number of IVT ranibizumab injections needed up to Week 24 (Visit 7) in the study eye. Exploratory efficacy variables: Identification of antibodies (biomarkers) against retinal antigens in patients with neovascular AMD treated with ranibizumab and healthy subjects. Validation of antibodies (biomarkers) against retinal antigens in patients with neovascular AMD treated with ranibizumab and healthy subjects found in previous studies. To correlate functional and structural parameters (BCVA and central retinal thickness) with the identified biomarkers to differentiate between initial and deferred responders. Secondary safety variables: Ongoing safety assessments will include ophthalmic examinations and the recording and evaluation of clinical adverse events (AEs). ;Timepoint(s) of evaluation of this end point: week 24 | — |
Countries
Germany
Contacts
Public ContactClinical Trial Center
University Medical Center of Johannes-Gutenberg University Mainz
Outcome results
None listed