Prednisolone eye drop in chronic central serous chorioretinopathy: a randomised clinical trial

Pred Forte® in chronic central serous chorioretinopathy - PICS Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000338-41-NL

Enrollment

Registered

2022-03-28

Start date

2022-05-04

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic central serous chorioretinopathy

Interventions

Trade Name: Predforte Pharmaceutical Form: Pharmaceutical form of the placebo: Ear/eye drops, suspension Route of administration of the placebo: Topical

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - diagnosis of severe chronic central serous chorioretinopathy - 18 years or older and doesn’t meet any exclusion criteria - is willing to sign the consent form - is able to self-administer eye drops. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - when there is evidence of another retinal diagnoses, such as a history of exudative age-related macular degeneration, suspicion of secondary choroidal neovascularization, polypoidal choroidal vasculopathy, multifocal choroiditis, retinal vascular occlusions, pseudoxanthoma elasticum, amblyopia, and severe myopia (more than -6 dioptres) - woman that are pregnant or breast feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) To assess the treatment response of cCSC cases to topical prednisolone 3-times daily ;Secondary Objective: 2) To gain insight in mechanism of action trough multimodal imaging 3) To investigate the effect of prednisolone on intraocular pressure;Primary end point(s): A difference between the efficacies of Pred Forte® versus placebo treatment based on the anatomical effect on OCT (reduction or absence of SRF versus persistence or increase of SRF). ;Timepoint(s) of evaluation of this end point: after 4 weeks of treatment	—

Measure

Time frame

Main Objective: 1) To assess the treatment response of cCSC cases to topical prednisolone 3-times daily ;Secondary Objective: 2) To gain insight in mechanism of action trough multimodal imaging 3) To investigate the effect of prednisolone on intraocular pressure;Primary end point(s): A difference between the efficacies of Pred Forte® versus placebo treatment based on the anatomical effect on OCT (reduction or absence of SRF versus persistence or increase of SRF). ;Timepoint(s) of evaluation of this end point: after 4 weeks of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): - Compare mean change in BCVA in the study eye at initiation and study endpoint - Compare mean change in IOP in the study eye at initiation and study endpoint - Compare possible differences on multimodal imaging between initiation and study endpoint ;Timepoint(s) of evaluation of this end point: after 4 weeks of treatment	—

Countries

Netherlands

Contacts

Public ContactTrial center Ophthalmology

Stichting Radboud universitair medisch centrum

trialcentrumohk@radboudumc.nl31243613212

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026