E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Wet age-related macular degeneration, diabetic macular edema, central retinal vein occlusion |
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E.1.1.1 | Medical condition in easily understood language |
Wet age-related macular degeneration, diabetic macular edema, central retinal vein occlusion |
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E.1.1.2 | Therapeutic area | Body processes [G] - Ocular Physiological Phenomena [G14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012675 |
E.1.2 | Term | Diabetic macular retinopathy |
E.1.2 | System Organ Class | 100000004853 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007972 |
E.1.2 | Term | Central retinal vein occlusion |
E.1.2 | System Organ Class | 100000004853 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015902 |
E.1.2 | Term | Exudative senile macular degeneration of retina |
E.1.2 | System Organ Class | 100000004853 |
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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 how the visual evoked potential (VEP) changes after the anti-VEGF injections |
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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 |
All subjects are over 18 years old and subjects in AMD group are over 65 years old. The symptoms of decreased central vision or blurred vision is not allowed to have lasted longer than eigth weeks before entering the study. In CRVO group only non-ischemic subtype is taken into this study.
A control group consists healthy subjects over 18 years old without macular oedema. |
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E.4 | Principal exclusion criteria |
- Pregnancy
- The eye previously treated with anti-VEGF injections
- Opthalmic surgery previously, only cataract surgery wihtout complications is allowed
- In AMD and CRVO groups diabetes is exclusion criteria.
Anti-VEGF injections or ophtalmic surgery of fellow eye is not an exclusion criteria.
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E.5 End points |
E.5.1 | Primary end point(s) |
The VEP changes after the anti-VEGF injections |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12-16 weeks after the beginning of the study |
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E.5.2 | Secondary end point(s) |
The correlation of VEP changes to the clinical findings |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
12-16 weeks after the beginning of the study |
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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 | 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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
Poikeaako VEP anti-VEGF -injektio hoidettujen potilaiden ja terveiden kontrollien välillä |
The difference of VEP between anti-VEGF treated patients and healthy control subjects |
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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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the last visit of the last subject |
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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 | |
E.8.9.1 | In the Member State concerned days | |