Pred Forte® versus placebo eye drops in chronic central serous chorioretinopathy trial (PICS trial)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Stichting Radboud University Medical Center

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

29 Jan 2025 → ongoing

Decision date (initial)

2025-01-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511575-15-00

EudraCT number

2022-000338-41

ClinicalTrials.gov

NCT05633576

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The main objective is to measure the effect of prednisolone eye drops and placebo on subretinal and intraretinal fluid in severe cCSC calculated by the cumulative areas of fluid objectified on optical coherence tomography (OCT).

Conditions and MedDRA coding

Central serous chorioretinopathy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Male and female patients aged 18 years or older Subretinal and/or intraretinal fluid on OCT and subjective visual loss or presence of Subretinal and/or intraretinal fluid for 3 months or longer Patient is able to self-administer eye drops Complex or Severe Chronic Central Serous Chorioretinopathy, with at least one of the following clinical findings that are present within the vascular arcades: Cumulative areas (>2 optic disc diameters) of diffuse atrophic RPE alterations visualized on mid-phase FA or on FAF; Multifocal "hot spots": at least 2 "hot spots" of leakage separated by at least 1 disc diameter of nonhyperfluorescent healthy-appearing retina on mid-phase FA; Diffuse leakage: an area of diffuse fluorescein leakage >1 optic disc diameter on mid-phase FA, without an evident leaking focus; Presence of posterior cystoid retinal degeneration assessed on OCT.

Exclusion criteria 1

1. Evidence of other retinal diagnoses: ((History of) exudative age-related macular degeneration, Suspicion of secondary choroidal neovascularization, Polypoidal choroidal vasculopathy, Multifocal choroiditis, Retinal vascular occlusions, Pseudoxanthoma elasticum, Amblyopia, Severe myopia (more than -6 diopters). Current treatment with corticosteroids or corticosteroid use within 3 months before the baseline visit Treatment with PDT, subthreshold micropulse laser or focal laser photocoagulation 6 months prior to the baseline visit. Treatment with anti-vascular endothelial growth factor (anti-VEGF), MR-antagonists or carbonic anhydrase inhibitors within 6 weeks prior to the baseline visit. If patients were treated with anti-VEGF, MR-antagonists or carbonic anhydrase inhibitors 3 months to 6 weeks prior to the baseline, patients will only be included if there was no sufficient response to treatment. Pregnant or breastfeeding women Allergy to topical ophthalmic steroids. Media opacities that prohibit detailed multimodal imaging (BCVA <20/200) (Snellen equivalent) Contraindications for fluorescein angiography or ICG angiography (known allergies especially against shellfish, previous reactions)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in sub- and intraretinal fluid on OCT scan: The primary outcome measure of this study is the effect of steroid eye drops in cCSC on the amount of sub and intraretinal fluid. The difference in the amount of sub- and intraretinal fluid will be compared between the OCT scan made prior to the study and the OCT scan made at the second consultation after the study medication has been used for four weeks.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Stichting Radboud University Medical Center

Sponsor organisation

Stichting Radboud University Medical Center

Address

Geert Grooteplein Zuid 10

City

Nijmegen

Postcode

6525 GA

Country

Netherlands

Scientific contact point

Organisation

Stichting Radboud University Medical Center

Contact name

Franca Christa Hartgers

Public contact point

Organisation

Stichting Radboud University Medical Center

Contact name

Franca Christa Hartgers

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications