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Study on the Effects of Prednisolone Acetate and Placebo Eye Drops for Patients with Chronic Central Serous Chorioretinopathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called Chronic Central Serous Chorioretinopathy (cCSC), which affects the eyes and can lead to vision problems. The study will test the effects of a medication called Pred Forte, which is an eye drop containing the active ingredient prednisolone acetate. Prednisolone acetate is a type of steroid that is often used to reduce inflammation. The trial will compare the effects of Pred Forte eye drops with a placebo to see how they affect fluid buildup in the eye, which is a common issue in cCSC.

The purpose of the study is to understand how well Pred Forte works in reducing the fluid in the eye that can cause vision problems in people with cCSC. Participants in the study will use the eye drops for a period of four weeks. During this time, the amount of fluid in their eyes will be measured using a special imaging technique called Optical Coherence Tomography (OCT). This technique helps doctors see detailed images of the eye's structure and is used to track changes in the fluid levels.

Throughout the study, participants will have their eye health monitored to assess any changes in the fluid levels before and after using the eye drops. The study aims to provide valuable information on whether Pred Forte can be an effective treatment option for managing cCSC and improving vision in affected individuals.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial consultation
The initial consultation involves a comprehensive eye examination to confirm the presence of central serous chorioretinopathy (cCSC).
An optical coherence tomography (OCT) scan is performed to assess subretinal and intraretinal fluid levels.
Step 2
Medication administration
The patient receives either Pred Forte 1.0% eye drops or placebo eye drops. The medication is administered for ocular use.
The dosage involves applying the eye drops as instructed by the healthcare provider, typically several times a day.
Step 3
Treatment duration
The treatment with the eye drops continues for a period of four weeks.
During this time, the patient is expected to self-administer the eye drops consistently as per the prescribed schedule.
Step 4
Follow-up consultation
A follow-up consultation is scheduled after the four-week treatment period.
Another OCT scan is conducted to measure changes in subretinal and intraretinal fluid levels.
Step 5
Evaluation of results
The primary outcome is the change in fluid levels as observed in the OCT scans before and after the treatment.
The effectiveness of the steroid eye drops is assessed by comparing the fluid levels from the initial and follow-up scans.

Who can join the trial?

11 criteria

Patients must be **18 years or older**.
Both **male and female** patients can participate.
Patients must have **subretinal** and/or **intraretinal fluid** visible on an eye scan called **OCT** (Optical Coherence Tomography). This fluid should be present for **3 months or longer**.
Patients should have experienced **subjective visual loss**, meaning they feel their vision has worsened.
Patients must be able to **self-administer eye drops**.
Patients should have **Complex or Severe Chronic Central Serous Chorioretinopathy** (cCSC), which is a specific eye condition.
Patients must have at least one of the following eye findings within the **vascular arcades** (the network of blood vessels in the eye):
**Cumulative areas** of damage in the eye's **RPE** (Retinal Pigment Epithelium) that are larger than **2 optic disc diameters**. This can be seen on special eye tests called **FA** (Fluorescein Angiography) or **FAF** (Fundus Autofluorescence).
**Multifocal "hot spots"**: At least 2 areas of fluid leakage in the eye, separated by at least 1 disc diameter of healthy-looking retina, seen on **FA**.
**Diffuse leakage**: An area of fluid leakage larger than **1 optic disc diameter** on **FA**, without a clear source of the leak.
Presence of **posterior cystoid retinal degeneration**, which is a type of eye damage, seen on **OCT**.

Who cannot join the trial?

3 criteria

Patients who are not diagnosed with Central Serous Chorioretinopathy cannot participate. This is a condition affecting the eye, where fluid builds up under the retina.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Stichting Radboud University Medical Center
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Nijmegen, The Netherlands

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Investigated drugs

Pred Forte is an eye drop medication containing prednisolone, which is a type of steroid. It is used in this trial to help reduce inflammation and fluid accumulation in the eye, specifically in patients with chronic central serous chorioretinopathy (cCSC). The goal is to see if these eye drops can effectively decrease the fluid in the retina, which is measured using a special imaging technique called optical coherence tomography (OCT).

What is already known about the treatment

Pred Forte – Pred Forte is administered as eye drops and is currently being studied in clinical trials for its effects on chronic central serous chorioretinopathy (cCSC). This medication is primarily used to reduce inflammation in the eye. It works by mimicking the action of natural corticosteroids, which help to decrease swelling and irritation. Pred Forte is classified as a corticosteroid, and its mechanism involves binding to glucocorticoid receptors, leading to the suppression of inflammatory responses.

Investigated diseases

Central Serous Chorioretinopathy – This eye condition involves the accumulation of fluid under the retina, leading to visual disturbances. It primarily affects the central area of the retina, known as the macula, which is responsible for sharp, detailed vision. The fluid buildup can cause the retina to detach slightly, resulting in blurred or distorted vision. The condition often occurs suddenly and can affect one or both eyes. It is more common in young to middle-aged adults and may be associated with stress or steroid use. Over time, the fluid may resolve on its own, but in some cases, it can persist or recur.