E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic central serous chorioretinopathy |
chronische Centrale sereuze chorioretinopathie |
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E.1.1.1 | Medical condition in easily understood language |
Central serous chorioretinopathy (CSC) is a disease that is characterized by the occurrence of subretinal fluid and is confined to the pachychoroid disease spectrum. |
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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 |
1) To assess the treatment response of cCSC cases to topical prednisolone 3-times daily
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E.2.2 | Secondary objectives of the trial |
2) To gain insight in mechanism of action trough multimodal imaging 3) To investigate the effect of prednisolone on intraocular pressure |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- diagnosis of severe chronic central serous chorioretinopathy - 18 years or older and doesn’t meet any exclusion criteria - is willing to sign the consent form - is able to self-administer eye drops. |
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E.4 | Principal exclusion criteria |
- when there is evidence of another retinal diagnoses, such as a history of exudative age-related macular degeneration, suspicion of secondary choroidal neovascularization, polypoidal choroidal vasculopathy, multifocal choroiditis, retinal vascular occlusions, pseudoxanthoma elasticum, amblyopia, and severe myopia (more than −6 dioptres) - woman that are pregnant or breast feeding |
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E.5 End points |
E.5.1 | Primary end point(s) |
A difference between the efficacies of Pred Forte® versus placebo treatment based on the anatomical effect on OCT (reduction or absence of SRF versus persistence or increase of SRF). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 4 weeks of treatment |
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E.5.2 | Secondary end point(s) |
- Compare mean change in BCVA in the study eye at initiation and study endpoint - Compare mean change in IOP in the study eye at initiation and study endpoint - Compare possible differences on multimodal imaging between initiation and study endpoint
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after 4 weeks of 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 | No |
E.6.4 | Safety | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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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End of trial: after all patients have been treated for 4 weeks |
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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 | |