E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Exudative senile macular degeneration of the retina |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015902 |
E.1.2 | Term | Exudative senile macular degeneration of retina |
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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 |
Investigate the dose response and retreatment criteria for the intravitreal application of Bevacizumab (Avastin) in the treatment of exudative age related macular degeneration (AMD). |
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E.2.2 | Secondary objectives of the trial |
Assess the value of new imaging techniques in detecting a response to treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion into the study is judged on the clinical examination, the lesion characteristics as defined by interpretation of fluorescein angiography (FFA) and the best corrected visual acuity (BCVA). The following lesions should be included:
Exudative age-related macular degeneration in first or second eyes with angiographic signs of active subfoveal or juxtafoveal choroidal neovascularization (CNV) on FFA and a BCVA of ≥35 ETDRS letters (6/60) or better. Lesions characterised as the following on angiography: • Classic CNV • Predominantly classic CNV • Occult CNV • Minimally classic CNV • Retinal pigment epithelial detachments • Retinal angiomatous proliferations (RAP) • Classic or occult CNV with blood > 50% of the lesion but no blood in the centre of the presumed foveal avascular zone (FAZ) • Classic, predominantly classic, minimally classic and occult CNV within 6 months after initiation of PDT treatment, a maximum of 2 PDT treatments and a loss of BCVA of ≥10 letters compared to baseline before PDT, irrespective of the angiographic picture • Classic, predominantly classic, minimally classic and occult CNV within 3 months after initiation of Macugen treatment, a maximum of 2 Macugen injections and a loss of BCVA of ≥10 letters compared to baseline before Macugen, irrespective of the angiographic lesion characteristics • Recurrent CNV following laser photocoagulation, irrespective of the angiographic picture
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E.4 | Principal exclusion criteria |
Exudative AMD with angiographic signs of subfoveal or juxtafoveal choroidal neovascularization (CNV) on FFA and: • Extrafoveal CNV (should undergo laser photocoagulation or PDT) • Retinal pigment epithelial tears • Lesion with blood > 50% of the whole lesion and blood in the centre of the presumed FAZ • Clinical and angiographic signs of fibrosis >50% of the lesion • Visual acuity < 35 ETDRS letters (6/60) • CNV not associated with AMD
2. Diastolic blood pressure >100 or systolic blood pressure >200 as determined by the mean of three separate measurements at baseline.
3. Patients with unstable medical status in particular cardiovascular disease which in the opinion of the investigator would preclude patient’s participation in the study
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E.5 End points |
E.5.1 | Primary end point(s) |
The main endpoint of the study is change in best corrected visual acuity (BCVA) compared to baseline. This will be assessed at 18 weeks and 54 weeks following first treatment. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
Alternate doses of Avastin |
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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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
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 | Information not present in EudraCT |
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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End of the trial will be 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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |