Steroid Eye Drops in Chronic Central Serous Chorioretinopathy

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Nov 21, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the use of steroid eye drops for treating a condition called chronic central serous chorioretinopathy (cCSC), which can cause blurry vision due to fluid buildup under the retina. The study involves 40 participants who will be randomly assigned to receive either steroid eye drops or a placebo (a treatment that looks like the real thing but has no active ingredients). Participants will use the eye drops three times a day for four weeks. The goal is to see if the steroid drops are effective and safe for improving vision and reducing fluid in the eye.

To be eligible for this trial, participants must be at least 18 years old and have had visual problems for three months or longer, along with specific types of fluid visible in their eyes. They should also be able to administer the eye drops themselves. However, individuals with certain other eye conditions, recent treatments, or allergies to steroid eye drops will not be included. This trial is currently recruiting participants, and being part of it could help advance our understanding of potential new treatments for this eye condition.

Gender

ALL

Eligibility criteria

• 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 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)