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

3 1 1

What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
The Rotterdam Eye Hospital Rotterdam The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
19.02.2023

Trial locations

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).

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.

Trial ID:
2024-511575-15-00
NCT ID:
NCT05633576
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on the Use of [18F]PSMA-1007 PET/CT Imaging for Detecting Prostate Cancer in Patients with Newly Diagnosed High-Risk or Very-High-Risk Conditions

    Recruiting

    3 1 1 1
    France Germany Italy The Netherlands Spain
  • Study on the Safety and Effectiveness of C1 Esterase Inhibitor and Sodium Chloride for Patients with Aneurysmal Subarachnoid Hemorrhage

    Recruiting

    2 1 1
    Investigated diseases:
    The Netherlands