Steroid Eye Drops in Chronic Central Serous Chorioretinopathy (NCT05633576) | Clinical Trial Compass
UnknownPhase 3
Steroid Eye Drops in Chronic Central Serous Chorioretinopathy
Netherlands40 participantsStarted 2023-02-19
Plain-language summary
In this pilot study the effect and safety of the use of steroid eye drops in chronic central serous chorioretinopathy (cCSC) will be evaluated. The study is conducted as a randomized single-blind placebo-controlled trial. Forty patients will be randomized to either steroid eye drops or placebo eye drops. Patients will self-administer the eye drops three times a day for four weeks.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 e…