Overview

Steroid Eye Drops in Chronic Central Serous Chorioretinopathy

Status:
Not yet recruiting
Trial end date:
2024-02-09
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radboud University Medical Center
Collaborator:
Oogziekenhuis Rotterdam
Treatments:
Ophthalmic Solutions
Criteria
Inclusion Criteria:

- Male and female patients aged 18 years or older

- Subretinal and/or intraretinal fluid for 3 months or longer

- Patient is able to self-administer eye drops

- Severe Chronic Central Serous Chorioretinopathy, with at least one of the following
clinical findings are present within the vascular arcades: Cumulative areas (>5 optic
disc diameters) of diffuse atrophic RPE alterations visualized on mid-phase FA;
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).

- 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)