NL-OMON39842CompletedPhase 4
A prospective randomised controlled multicentre trial comparing half-dose photodynamic therapy (PDT) with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy (CSC). - Prospective Randomised Controlled Treatment Trial for Chronic CSC (PLACE)
niversitair Medisch Centrum0 sites119 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 119
Study Overview
Brief Summary
Trial is onging in other countries
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Male and female patients >= 18 years of age who are able to give written informed consent
- •- Presence of active chronic central serous chorioretinopathy (CSC)
- •- Subjective visual loss > 6 weeks, interpreted as onset of active disease
- •- Subretinal fluid that includes the fovea on optical coherence tomography (OCT) scanning at
- •Baseline Examination.
- •PLEASE NOTE: Subretinal fluid does not have to include fovea on OCT to be eligible for treatment at Control Visit 1, as long as there is persistent subretinal fluid in the macula, which is interpreted as persistently active disease
- •- Hyperfluorescent areas on indocyanin green (ICG) angiography
- •- >=1 ill-defined hyperfluorescent leakage areas on fluorescein angiography (FA) with retinal pigment epithelial window defect(s) that are compatible with chronic CSC
Exclusion Criteria
- •- Any previous treatments for active CSC in the study eye
- •- Current treatment with corticosteroids (topical or systemic), or anticipated start of corticosteroid treatment within the first 7-8 months from the start of the trial period
- •- Evidence of other diagnosis that can explain serous subretinal fluid or visual loss
- •- BCVA < 20/200 (Snellen equivalent)
- •- Profound chorioretinal atrophy in central macular area on ophthalmoscopy and OCT
- •- Myopia > 6D
- •- Visual loss and/or serous detachment on OCT < 6 weeks
- •- Continuous and/or progressive visual loss > 18 months or serous detachment on OCT > 18 months
- •- No hyperfluorescence on ICG angiography
- •- Intraretinal edema on OCT
- •- (Relative) contraindications for PDT treatment (pregnancy, porphyria, severely disturbed liver function). Pregnancy will not be routinely tested in female patients, but the possibility of pregnancy will be discussed during eligibility screening
- •- (Relative) contraindications for FA or ICG angiography (known allergies especially against shellfish, previous reactions)
- •- Soft drusen in treated eye or fellow eye, signs of choroidal neovascularization on ophthalmoscopy and/or FA or ICG angiography
Investigators
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