Pred Forte® in chronic central serous chorioretinopathy

Severe chronic central serous chorioretinopathy (cCSC) is a disease part of the
pachychoroid disease spectrum and is characterized by the presence of
subretinal and intraretinal fluid. Left untreated these patients are at serious
risk of irreversible vision loss. The only effective treatment is photodynamic
therapy (PDT), which is expensive and invasive and currently unavailable. It is
well-known that pachychoroid diseases can be induced by the use of systemic
steroids or an increase in cortisol (stress related). We have seen a strikingly
good effect on sub- and intraretinal fluid in other diseases that are part of
the pachychoroid disease spectrum by using topical steroidal eye drops. Our
hypothesis is that there is a disbalance in systemic versus intraocular
steroids. If systemic steroids cannot be lowered a local increase of steroids
in the involved eye may restore the intraocular-extraocular steroid balance. A
topical steroidal eye drop would be a great, cheap and easy to self-administer
alternative treatment to the expansive and invasive PDT therapy

This study has been transitioned to CTIS with ID 2024-511575-15-00 check the CTIS register for the current data.

The main objective is the measure the effect on subretinal and intraretinal
fluid in severe cCSC calculated by the cumulative areas of fluid objectified on
optical coherence tomography (OCT). Secondary objectives are to gain insight in
the mechanism of action through multimodal imaging and to investigate the
effect of topical steroids on the intraocular pressure (IOP).

A pilot study in which we will assess the effect on fluid in a randomized
placebo-controlled study. This moisture can be easily detected (and the surface
area can be calculated well) with an OCT scan of the retina. We aim to include
20 patients with cCSC in each arm. The duration of the study is 4 weeks. These
patients have chronic fluid in or below the retina, and these 4 weeks will
therefore not have a lasting negative effect on the retina, in the absence of a
positive response. There is currently no alternative treatment for these
patients.

cCSC patients will be treated with Pred Forte® (PF®) eye drops or with placebo
eye drops 3 times a day for 4 weeks

All patients will undergo multimodal imaging before inclusion and at the end
point of the study, this includes invasive studies. All studies are part of the
regular clinical work-up for cCSC and no additional (invasive) investigations
will be performed.
The use of PF® holds the risk of an increasement of intraocular pressure (IOP)
and may induce cataract. However, both these risks are neglectable when used
for 4 weeks only and outweighs the possible reductive effect of PF® on
subretinal and intraretinal fluid.