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Pred Forte® in chronic central serous chorioretinopathy

Pred Forte® in chronic central serous chorioretinopathy - PICS Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51739
Enrollment
40
Registered
2022-03-28
Start date
2023-02-19
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

central serous chorioretinopathy CSC

Interventions

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

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis of severe chronic central serous chorioretinopathy that meets the criteria outlined in section 6.1 of protocol - 18 years or older - doesn*t meet any exclusion criteria, is willing to sign the consent form - able to self-administer eye drops.

Exclusion criteria

Exclusion criteria: - evidence of another retinal diagnoses, such as 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). - women that are breast feeding or pregnant

Design outcomes

Primary

MeasureTime frame
To investigate whether PF® topical eye drops lead to a reduction of intraretinal and subretinal fluid after 4 weeks in comparison to placebo eye drops. Treatment response is objectified by OCT

Secondary

MeasureTime frame
Secondary endpoints in this study are changes in best-corrected visual acuity and changes on multimodal imaging.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)