Evaluation of Prednisolone Acetate and Placebo Eye Drops in Patients with Chronic Central Serous Chorioretinopathy

The primary objective of the study is to evaluate the effect of **prednisolone** eye drops compared to placebo on subretinal and intraretinal fluid in patients with severe chronic central serous chorioretinopathy (cCSC). This is assessed by measuring the cumulative areas of fluid as visualized on optical coherence tomography (OCT). The clinical relevance of this objective lies in determining the efficacy of prednisolone in reducing retinal fluid accumulation, which is a significant factor in the progression and visual impairment associated with cCSC.

The clinical trial involves participants diagnosed with **central serous chorioretinopathy**. The study population includes both male and female subjects aged 18 years or older. Participants are required to have subretinal and/or intraretinal fluid as observed on optical coherence tomography (OCT), along with subjective visual loss or the presence of fluid for three months or longer. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants must be capable of self-administering eye drops. The selection criteria focus on individuals with complex or severe chronic central serous chorioretinopathy, characterized by specific clinical findings such as cumulative areas of diffuse atrophic retinal pigment epithelium alterations, multifocal "hot spots" of leakage, diffuse leakage, or posterior cystoid retinal degeneration as assessed on OCT. No specific lifestyle considerations such as diet or physical activity are mentioned for this trial.

The clinical trial is designed to evaluate the efficacy of **prednisolone acetate** eye drops compared to placebo in patients with chronic central serous chorioretinopathy (cCSC). This study is a randomized, double-blind, controlled trial, ensuring that neither the participants nor the investigators know which treatment the participants are receiving, thereby minimizing bias. The trial is expected to last until July 2025, with recruitment having commenced in February 2023. Participants will be involved in the study for a maximum treatment period of four weeks, during which they will self-administer the eye drops up to three times daily.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is assessed based on criteria such as age (18 years or older), presence of subretinal and/or intraretinal fluid on optical coherence tomography (OCT), and the ability to self-administer eye drops. Following the screening, participants will undergo a baseline OCT scan to quantify subretinal and intraretinal fluid. Subsequent follow-up visits will occur at regular intervals to monitor changes in fluid levels, with a primary endpoint being the difference in fluid amount between the initial and a follow-up OCT scan after four weeks of treatment. The end-of-study visit will involve a final assessment to evaluate the overall effect of the treatment.

Participants may be withdrawn from the study if they experience adverse effects that compromise their safety or if they fail to comply with the study protocol. The primary outcome measure is the change in sub- and intraretinal fluid as observed on OCT scans, which will be compared between the baseline and the second consultation post-treatment. The trial aims to provide valuable insights into the therapeutic potential of steroid eye drops in managing cCSC, contributing to the broader understanding of treatment options for this condition.

The clinical trial involves the use of **DURATEARS** eye drops, a solution containing the active substances **dextran 70** and **hypromellose**. These substances are formulated as a mixture and polymer, respectively. The pharmaceutical form is an eye drop solution, and the product is manufactured by Alcon Nederland B.V. The administration route is ocular, with a maximum daily dosage of three drops per day. The treatment period is limited to a maximum of four weeks. DURATEARS is classified under the ATC code S01XA20, which pertains to artificial tears and other indifferent preparations. Participant compliance with the dosing schedule will be monitored throughout the trial.

The comparator treatment in this trial is **Pred Forte 1.0%** eye drops, a suspension containing the active substance **prednisolone acetate**, a chemical compound. This product is manufactured by AbbVie S.A. and is also administered via ocular use. The pharmaceutical form is an eye drop suspension, and the maximum daily dosage is three drops per day, with a treatment period not exceeding four weeks. Pred Forte is classified under the ATC code S01BA04, which is specific to prednisolone. The product has undergone re-packaging and re-labelling for the purposes of this trial. Compliance with the dosing regimen will be closely monitored to ensure adherence to the study protocol.

The efficacy of the clinical trial titled "Pred Forte® versus placebo eye drops in chronic central serous chorioretinopathy trial (PICS trial)" will be assessed by evaluating the change in subretinal and intraretinal fluid in patients with severe chronic central serous chorioretinopathy (**cCSC**). The primary endpoint is the change in the amount of sub- and intraretinal fluid, which will be measured using optical coherence tomography (OCT) scans. The OCT scans will be conducted prior to the study and at the second consultation after four weeks of using the study medication. The primary outcome measure will focus on the effect of steroid eye drops on the amount of sub- and intraretinal fluid, comparing the differences observed in the OCT scans before and after the treatment period.