Steroid Eye Drops Versus Placebo Eye Drops in Chronic Central Serous Chorioretinopathy Trial (PICS Trial)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Radboud University Medical Center
NOT_YET_RECRUITING
Nijmegen
Rotterdam Eye Hospital
RECRUITING
Rotterdam
Time Frame
Start Date: 2023-02-19
Estimated Completion Date: 2025-07-19
Participants
Target number of participants: 40
Treatments
Active_comparator: steroid eye drops
In this treatment arm, patients will self-administer the steroid eye drops three times a day for four consecutive weeks.
Placebo_comparator: Placebo
In this treatment arm, patients will self-administer the placebo eye drops three times a day for four consecutive weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Oogziekenhuis Rotterdam
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov