Chronic Central Serous ChorioretinopathyPhase 3PICSNCT05633576
Steroid Eye Drops in Chronic Central Serous Chorioretinopathy
A Phase 3 study testing steroid eye drops in people with Chronic Central Serous Chorioretinopathy, run by Radboud University Medical Center at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Central Serous Chorioretinopathy
- What is being tested?
- steroid eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesNetherlands
- Study dates
- 19 Feb 2023to 19 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Radboud University Medical Center
Nijmegen
S. Yzer, MD, PhD
- Recruiting
Rotterdam Eye Hospital
Rotterdam
Martinez, 0104023449, roi@oogziekenhuis.nl
About this study
Official title: Steroid Eye Drops Versus Placebo Eye Drops in Chronic Central Serous Chorioretinopathy Trial (PICS Trial)
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.
Read the detailed description
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 most effective treatment is photodynamic therapy (PDT), which is expensive, invasive and currently only available to a limited extent. Pachychoroid diseases are correlated to the use of systemic steroids or an increase in cortisol, to stress, sleep apnea and sildenafil use. In many cases there is no clear correlation to one of the risk factors. However, in clinical practice, a strikingly good effect on sub- and intraretinal fluid in another disease that is part of the pachychoroid disease spectrum was seen by using steroid eye drops (PPS; peripapillary pachychoroid disease). Steroid eye drops are used in many ophthalmic diseases, however, there is no clinical experience for the use steroid eye drops in cCSC.
The aim of this study is to assess the safety and the effect of steroid eye drops in patients suffering from cCSC for clinical, multimodal imaging, anatomical and functional outcomes. In addition, we want to gain insight in the mechanism of action and to investigate the effect of topical steroids on the intraocular pressure.
No previous studies have evaluated the effect of steroid eye drops on cCSC, therefore this study is set up as a pilot study, with a randomized, single-blinded, placebo controlled trial design. In total, 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. The study will last for four weeks per patient and each patient will visit the outpatient clinic 2 times.
Treatment response will be objectified by multimodal imaging and by measuring the best-corrected visual acuity, after four weeks of using steroid eye drops or placebo.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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 steroid eye drops 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 steroid eye drops on subretinal and intraretinal fluid.
- Conditions
- Chronic Central Serous Chorioretinopathy
- Being tested
- steroid eye drops, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steroid eye dropsDrug
Self-administration of steroid eye drops three times a day for four consecutive weeks.
PlaceboDrug
Self-administration of placebo eye drops three times a day for four consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after the start of treatment
Secondary outcomes (4)
Change in best corrected visual acuity
Mean change in BCVA between baseline and after using the study medication for 4 weeks.
Measured: 1 month after the start of treatment
Intra ocular pressure (IOP)
Mean change in IOP between baseline and after using the study medication for 4 weeks.
Measured: 1 month after the start of treatment
Change of hyperfluorescent areas on fluorescence angiography (FA)
Mean change in hyperfluorescent areas on FA between baseline and after using the study medication for 4 weeks.
Measured: 1 month after the start of treatment
Change of hypercyanescent areas on Indocyanine Green Angiography (ICGA)
Mean change in hypercyanescent areas on ICGA between baseline and after using the study medication for 4 weeks.
Measured: 1 month after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start19 Feb 2023
- Primary completion19 Jun 2025 (estimated)
- Study completion19 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Oogziekenhuis Rotterdam
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633576
- Sponsor's protocol ID
- 112907
- Acronym
- PICS
- Status last verified
- Apr 2024
- First submitted
- 21 Nov 2022
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steroid Eye Drops Versus Placebo Eye Drops in Chronic Central Serous Chorioretinopathy Trial (PICS Trial)
- ClinicalTrials.gov ID
- NCT05633576
- Acronym / sponsor ID
- PICS / 112907
- Conditions
- Chronic Central Serous Chorioretinopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Oogziekenhuis Rotterdam
- Study start
- 19 Feb 2023 (actual)
- Primary completion
- 19 Jun 2025 (estimated)
- Study completion
- 19 Jul 2025 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 most effective treatment is photodynamic therapy (PDT), which is expensive, invasive and currently only available to a limited extent. Pachychoroid diseases are correlated to the use of systemic steroids or an increase in cortisol, to stress, sleep apnea and sildenafil use. In many cases there is no clear correlation to one of the risk factors. However, in clinical practice, a strikingly good effect on sub- and intraretinal fluid in another disease that is part of the pachychoroid disease spectrum was seen by using steroid eye drops (PPS; peripapillary pachychoroid disease). Steroid eye drops are used in many ophthalmic diseases, however, there is no clinical experience for the use steroid eye drops in cCSC.
The aim of this study is to assess the safety and the effect of steroid eye drops in patients suffering from cCSC for clinical, multimodal imaging, anatomical and functional outcomes. In addition, we want to gain insight in the mechanism of action and to investigate the effect of topical steroids on the intraocular pressure.
No previous studies have evaluated the effect of steroid eye drops on cCSC, therefore this study is set up as a pilot study, with a randomized, single-blinded, placebo controlled trial design. In total, 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. The study will last for four weeks per patient and each patient will visit the outpatient clinic 2 times.
Treatment response will be objectified by multimodal imaging and by measuring the best-corrected visual acuity, after four weeks of using steroid eye drops or placebo.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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 steroid eye drops 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 steroid eye drops on subretinal and intraretinal fluid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| steroid eye drops | Active comparator | Drug: steroid eye dropsIn this treatment arm, patients will self-administer the steroid eye drops three times a day for four consecutive weeks. |
| Placebo | Placebo comparator | Drug: PlaceboIn this treatment arm, patients will self-administer the placebo eye drops three times a day for four consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| steroid eye dropsSelf-administration of steroid eye drops three times a day for four consecutive weeks. | Drug | steroid eye drops |
| PlaceboSelf-administration of placebo eye drops three times a day for four consecutive weeks. | Drug | Placebo |
Primary outcome
Change in sub- and intraretinal fluid on OCT scan
Time frame: 1 month after the start of treatment
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.
4 secondary outcomes
Change in best corrected visual acuity
Time frame: 1 month after the start of treatment
Intra ocular pressure (IOP)
Time frame: 1 month after the start of treatment
Change of hyperfluorescent areas on fluorescence angiography (FA)
Time frame: 1 month after the start of treatment
Change of hypercyanescent areas on Indocyanine Green Angiography (ICGA)
Time frame: 1 month after the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No. No plan to share IPD
Related trials for Chronic Central Serous Chorioretinopathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing steroid eye drops in people with Chronic Central Serous Chorioretinopathy, run by Radboud University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sub- and intraretinal fluid on OCT scan (time frame: 1 month after the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.