E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Choroidal neovascularisation and chronic macular edema |
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E.1.1.1 | Medical condition in easily understood language |
Choroidal neovascularisation and chronic macular edema |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054467 |
E.1.2 | Term | Macular edema |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060823 |
E.1.2 | Term | Choroidal neovascularisation |
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 |
evaluate the long-term safety and efficacy of intravitreal treatment with bevacizumab by registration of best corrected visual acuity, side-effects and central retinal thickness as measured with the ocular coherence tomography if available |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age ≥ 18 years of either gender 2. Written informed consent must be obtained before any intravitreal injection of bevacizumab is performed 3. Visual impairment predominantly due to abnormal new vessel ingrowth and/or macular edema. The prescence of fluid (intraretinal, subretinal or sub-RPE) detected clinically or on the OCT. If both eyes are eligible for the study, both eyes can be included in the study
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E.4 | Principal exclusion criteria |
1. Women who are pregnant or breastfeeding (pregnancy defined as the state of a female after conception until the termination of gestation, confirmed by a positive hCG laboratory test (> 5mIU/mL) Women of child bearing potential must be practicing effective contraception implemented during the trial and for at least 28 days following the last dose of study medication 2. Tromboembolic event (CVA or TIA, AMI) less than 3 months prior to the intravitreal injection of bevacizumab 3. History of hypersensitivity for bevacizumab.
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E.5 End points |
E.5.1 | Primary end point(s) |
to compare the results of the centre with the results of several phase 3 trials from the literature and will guide improvements in the treatment protocols. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
This investigation will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity. The necessity of these investigations is determined by the degree of activity and as deemed necessary by the investigator |
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E.5.2 | Secondary end point(s) |
Each visit, the visual acuity will be measured in the study eye with dilated fundus examination, ocular coherence tomography and fluorescein angiography |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
This investigation will be performed with a 1, 3 or 6 month interval (or more frequent) as long as there are signs of disease activity. The necessity of these investigations is determined by the degree of activity and as deemed necessary by the investigator |
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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 | No |
E.6.4 | Safety | Yes |
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 | No |
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 | No |
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 | No |
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 | 30 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |