Steroid Eye Drops in Chronic Central Serous Chorioretinopathy

NCT05633576 | Recruiting Phase 3

• 1 other identifier: 112907
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

In this pilot study the effect and safety of the use of steroid eye drops in chronic central serous chorioretinopathy (cCSC) will be evaluated. The study is conducted as a randomized single-blind placebo-controlled trial. Forty patients will be randomized to either steroid eye drops or placebo eye drops. Patients will self-administer the eye drops three times a day for four weeks.

Conditions

Chronic Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (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.

  1 month after the start of treatment

Secondary Outcomes (4)

• Change in best corrected visual acuity

  1 month after the start of treatment

• Intra ocular pressure (IOP)

  1 month after the start of treatment

• Change of hyperfluorescent areas on fluorescence angiography (FA)

  1 month after the start of treatment

• Change of hypercyanescent areas on Indocyanine Green Angiography (ICGA)

  1 month after the start of treatment

Study Arms (2)

steroid eye drops

ACTIVE COMPARATOR

In this treatment arm, patients will self-administer the steroid eye drops three times a day for four consecutive weeks.

Drug: steroid eye drops

Placebo

PLACEBO COMPARATOR

In this treatment arm, patients will self-administer the placebo eye drops three times a day for four consecutive weeks.

Drug: Placebo

Interventions

steroid eye drops DRUG

Self-administration of steroid eye drops three times a day for four consecutive weeks.

steroid eye drops

Placebo DRUG

Self-administration of placebo eye drops three times a day for four consecutive weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Oogziekenhuis Rotterdam: collaborator

Study Sites (2)

Radboud University Medical Center

Nijmegen, Netherlands

NOT YET RECRUITING

Rotterdam Eye Hospital

Rotterdam, Netherlands

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: February 19, 2023
• Primary Completion: June 19, 2025
• Study Completion: July 19, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)