E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Neovascular Age-related macular degeneration |
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E.1.1.1 | Medical condition in easily understood language |
wet age-related macular degeneration |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
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 |
The objective of this study is to examine features of treatment response on optical coherence tomography in patients with neovascular age-related macular degeneration who switched to aflibercept after non-response to previous intravitreal anti-VEGF treatment. |
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E.2.2 | Secondary objectives of the trial |
To examine change in visual acuity in patients with neovascular age-related macular degeneration who switched to aflibercept after non-response to previous intravitreal anti-VEGF treatment.
To evaluate the number of patients responding to aflibercept.
To evaluate the number of patients gaining >5 letters of visual acuity from inclusion to study end.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients will have received at least 6 anti-VEGF injections within 1 year.
- Active neovascular AMD seen as leakage on FA and (sub-) retinal fluid on OCT.
- Maximally 1 year since onset of visual complaints and start of anti-VEGF treatment.
- Minimally 1 month and maximally 3 months between last anti-VEGF injection and first aflibercept injection.
- Age 50 years and older
- Visual acuity at baseline between 20/25 and 20/320.
- OCT available prior to first injection and after every three anti-VEGF injections.
- Give written informed consent.
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E.4 | Principal exclusion criteria |
- Signs of subretinal fibrosis, scarring or geographic atrophy on OCT or FA, involving the center of the macula.
- Pigment epithelial detachment with a maximum height of ≥150μm.
- Any ocular diseases beside AMD in the study eye, including myopic fundus and vitreoretinal traction.
- Myopia of 8.00 D or more, irrespective of myopic fundus features.
- Ocular surgery of the study eye ≤ 2 months prior to or during the previous anti-VEGF treatment.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in central retinal thickness as measured on OCT between inclusion and one month after 3 monthly aflibercept injections. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At baseline and after 3 months. |
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E.5.2 | Secondary end point(s) |
o Change in visual acuity between inclusion and one month after 3 monthly aflibercept injections.
o Number of patients responding to aflibercept defined as a decrease in CRT of >50μm from inclusion compared to visit 5.
o Number of patients gaining >5 letters of vision from inclusion compared to visit 5.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At baseline and after 3 months. |
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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 | No |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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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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 | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |