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Pred Forte® versus placebo eye drops in chronic central serous chorioretinopathy trial (PICS trial)
EU CTIS ID: 2024-511575-15-00
What this study is testing
The main objective is to measure the effect of prednisolone eye drops and placebo on subretinal and intraretinal fluid in severe cCSC calculated by the cumulative areas of fluid objectified on optical coherence tomography (OCT).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female patients aged 18 years or older Subretinal and/or intraretinal fluid on OCT and subjective visual loss or presence of Subretinal and/or intraretinal fluid for 3 months or longer Patient is able to self-administer eye drops Complex or Severe Chronic Central Serous Chorioretinopathy, with at least one of the following clinical findings that are present within the vascular arcades: Cumulative areas (>2 optic disc diameters) of diffuse atrophic RPE alterations visualized on mid-phase FA or on FAF; Multifocal "hot spots": at least 2 "hot spots" of leakage separated by at least 1 disc diameter of nonhyperfluorescent healthy-appearing retina on mid-phase FA; Diffuse leakage: an area of diffuse fluorescein leakage >1 optic disc diameter on mid-phase FA, without an evident leaking focus; Presence of posterior cystoid retinal degeneration assessed on OCT.
You likely can't join if
- Evidence of other retinal diagnoses: ((History of) exudative age-related macular degeneration, Suspicion of secondary choroidal neovascularization, Polypoidal choroidal vasculopathy, Multifocal choroiditis, Retinal vascular occlusions, Pseudoxanthoma elasticum, Amblyopia, Severe myopia (more than -6 diopters). Current treatment with corticosteroids or corticosteroid use within 3 months before the baseline visit Treatment with PDT, subthreshold micropulse laser or focal laser photocoagulation 6 months prior to the baseline visit. Treatment with anti-vascular endothelial growth factor (anti-VEGF), MR-antagonists or carbonic anhydrase inhibitors within 6 weeks prior to the baseline visit. If patients were treated with anti-VEGF, MR-antagonists or carbonic anhydrase inhibitors 3 months to 6 weeks prior to the baseline, patients will only be included if there was no sufficient response to treatment. Pregnant or breastfeeding women Allergy to topical ophthalmic steroids. Media opacities that prohibit detailed multimodal imaging (BCVA <20/200) (Snellen equivalent) Contraindications for fluorescein angiography or ICG angiography (known allergies especially against shellfish, previous reactions)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.