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 |
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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 | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10064930 |
E.1.2 | Term | 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 investigate the care of IVAN participants in the NHS, and changes to their vision, since the end of the IVAN trial in order to better inform future NHS strategies for treatment of wet Age-related Macular Degeneration. |
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E.2.2 | Secondary objectives of the trial |
Geographic Atrophy (GA) is a physical change that happens in the back of the eye. It can be measured and graded. Images taken in the original IVAN study, on average between 3 and 5 years ago, can be compared against images taken during this study. From that comparison we can;
• Describe how many of the IVAN participants have developed Geographic Atrophy. • Describe the rate of change in those participants who already had Geographic Atrophy. • Estimate if there was any link or effect between the Geographic Atrophy severity and the the trial allocations, the numbers of treatments administered during the trial, the participants’ management and clinical outcomes and health status (as measured using questionnaires). • To estimate the effects of original trial allocations on the rate of development of new Geographic Atrophy. • To investigate whether new Geographic Atrophy has a long term impact on visual function and health status (as measured using questionnaires), which could poten |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: i) Participated in the original IVAN trial. For attended visits and the postal questionnaire: ii) Able to give informed consent.
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome will be the development of new atrophy. This outcome will be determined from colour fundus (CF), OCT and autofluorescence images (where available) of the study eye. The images are submitted to the Network of Ophthalmic Reading Centres (NetwORC). NetwORC will grade all images that are submitted without knowledge of experimental allocations or other exposures of interest and classify study eyes as having developed new atrophy or not. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
This will be at one timepoint on average 5 years since enrollment in the IVAN trial. |
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E.5.2 | Secondary end point(s) |
• Best corrected distance visual acuity (BCVA; VAlogMAR), with standard and low luminance, using the standard ETDRS Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. This will be recorded for each visit from a participant’s medical record for both study and fellow eyes.
• Duration of monitoring for reactivation: This will be derived from the date of first treatment in the IVAN trial and the date of the last / most recent monitoring visit documented in the medical records. If a participant has been discharged at some point since exiting the IVAN trial, then restarted treatment, the date of restarting treatment (and subsequent cessation of monitoring) will be recorded. If a fellow eye has developed nAMD requiring treatment during or after exiting the IVAN trial, the same information will be recorded for the fellow eye. • Number of visits: In addition, the eye(s) being monitored at each visit will be recorded, i.e. study, fellow or both. • Number of injections: This outcome will be recorded separately for study and fellow eyes. The drug used for each treatment will also be recorded • nAMD status of fellow eye • EuroQol EQ-5D-5L
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Long term disease progression/effect of long term NHS treatment |
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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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 21 |
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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The end of the study is when all data queries are answered, the database is closed and the paper is at least drafted. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 31 |