Status:
COMPLETED
Prospective Randomized Controlled Treatment Trial for Chronic Central Serous Chorioretinopathy
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
University of Cologne
University of Oxford
Conditions:
Chronic Central Serous Chorioretinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Chronic central serous chorioretinopathy (CSC) is a relatively frequent eye disease that often occurs in patients in the professionally active age range. In this disease, there is pooling of fluid und...
Detailed Description
PURPOSE AND DESIGN There is no international consensus on the optimal treatment protocol of chronic CSC. Nevertheless, photodynamic therapy (PDT) has emerged as the treatment of choice in many centres...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- male and female patients ≥ 18 years of age who are able to give written informed consent
- active chronic central serous chorioretinopathy
- subjective visual loss \> 6 weeks, interpreted as onset of active disease
- subretinal fluid that includes the fovea on 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 (see 5.7 "Retreatment criteria and considerations").
- hyperfluorescent areas on ICG angiography
- ≥1 ill-defined hyperfluorescent leakage areas on fluorescein angiography with retinal pigment epithelial window defect(s) that are compatible with chronic CSC
- EXCLUSION CRITERIA:
- The participant may not enter the study if ANY of the following apply:
- 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 \> 6 dioptres
- 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 fluorescein angiography 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 fluorescein angiography/indocyanine green angiography
Exclusion
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2017
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01797861
Start Date
December 1 2013
End Date
May 1 2017
Last Update
October 10 2017
Active Locations (5)
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1
Creteil University Eye Clinic
Paris, France, 94010
2
Cologne University Eye Clinic
Cologne, Germany, 50937
3
Leiden University Medical Center
Leiden, Netherlands
4
Radboud University Nijmegen Medical Centre, Institute of Ophthalmology
Nijmegen, Netherlands, 6500 HB