Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT01797861
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01797861
Study Brief:
Protocol Section:
NCT01797861