E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neovascular age-related macular degeneration (AMD) |
neovaskularisierende AMD |
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E.1.1.1 | Medical condition in easily understood language |
Neovascular age-related macular degeneration (AMD) |
feuchte AMD |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10071129 |
E.1.2 | Term | Neovascular age-related macular degeneration |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the efficacy (change in BCVA) of IVT administered ranibizumab in subjects with all subtypes of neovascular AMD. |
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E.2.2 | Secondary objectives of the trial |
• 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 20 |