Using steroid eye drops to treat chronic central serous chorioretinopathy
Steroid Eye Drops Versus Placebo Eye Drops in Chronic Central Serous Chorioretinopathy Trial (PICS Trial)
This study is testing whether steroid eye drops can help people with chronic central serous chorioretinopathy feel better and improve their vision.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 2 sites (Nijmegen and 1 other locations) |
| Trial ID | NCT05633576 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety and effectiveness of steroid eye drops in patients with chronic central serous chorioretinopathy (cCSC). It is designed as a randomized, single-blind, placebo-controlled trial involving forty patients who will self-administer the eye drops three times daily for four weeks. The study aims to assess clinical, imaging, anatomical, and functional outcomes, while also investigating the mechanism of action and the impact on intraocular pressure. This approach is novel as no previous studies have explored the use of steroid eye drops specifically for cCSC.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic central serous chorioretinopathy characterized by subretinal and/or intraretinal fluid and subjective visual loss.
Not a fit: Patients with other retinal diagnoses or those who do not meet the specific criteria for cCSC may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive alternative to current therapies for cCSC, potentially reducing the risk of vision loss.
How similar studies have performed: No previous studies have evaluated the effect of steroid eye drops on cCSC, making this approach novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Nijmegen and 1 other locations
- Radboud University Medical Center — Nijmegen, Netherlands (Not_yet_recruiting)
- Rotterdam Eye Hospital — Rotterdam, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.