Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective Randomized Controlled Multicentre Trial Comparing Half-dose Photodynamic Therapy (PDT) With High-density Subthreshold Micropulse Laser Treatment in Patients With Chronic Central Serous Chorioretinopathy (CSC)
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 under the central retina (the macula). This specific form of macular degeneration can cause permanent vision loss, image distortion, loss of color and contrast vision due to this fluid under the retina. An early diagnosis and treatment may improve the visual outcome and quality of life. To date there is no international consensus on the optimal treatment of chronic CSC. Many retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in chronic CSC. Micropulse laser (ML) therapy may also be effective in this disease.

The proposed study is the first prospective randomized controlled trial in chronic CSC. In this study, participants with chronic CSC will be randomized into two treatment groups, PDT or ML treatment. The trial is a superiority study, because retrospective studies suggest that PDT treatment may be more effective than ML treatment. Therefore, PDT treatment is challenged against ML treatment.

The null hypothesis of the study is that PDT treatment is more effective than ML treatment in patients with active chronic CSC. The alternative hypothesis is that PDT treatment is not more effective than ML treatment in these patients.

Treatment success will not only be based on anatomical improvement, but also on functional endpoints, which are most important from a patient's perspective.

The study will take place in five large tertiary referral university hospitals in Europe that have extensive experience with conducting clinical trials (in Nijmegen, the Netherlands; Cologne, Germany; Leiden, the Netherlands; Oxford, United Kingdom; and Paris, France). Each of these centers has confirmed sufficient funding to conduct the research. The study will last max. 8 months per participant. Each participant will come for 5 (in the case of 1 treatment) or 7 visits (in the case of 2 treatments). Study evaluations will be mostly part of regular clinical care. The whole study will last for max. 24 months.


Options:
A: Inclusion Criteria:

* Anamnestic reduction of visual acuity
* Atients with best-corrected visual acuity (BCVA) of 20/200 or better
* Presence of subretinal fluid (SRF) on optical coherence tomography (OCT)
* Presence of active angiographic (multi)focal leakage in fluorescein angiography (FA) caused by ICSC but not choroidal neovascularisation (CNV) or other diseases
* Absence of other retinal or ocular diseases (e. g. glaucoma, vessel diseases, vein occlusion or proliferative retinopathy)
* Absence of cataract or media opacities of a degree which precludes taking retinal photographs and FA's
* Absence of angle closure glaucoma which precludes pharmacological dilatation of the pupil.

Exclusion Criteria:

* Patients who received any previous treatment, including PDT or focal cw laser photocoagulation for ICSC, or who had evidence of CNV, PCV, or other maculopathy on clinical examination or FA were excluded.
* Patients receiving exogenous corticosteroid treatment, with systemic diseases such as Cushing's disease or renal diseases, and pregnant patients also were excluded.
* Informed consent was obtained from all subjects, and the study protocol was approved by the ethics committee of the University of Kiel.
B: Inclusion criteria:

* CSC of \>4 months duration

Exclusion Criteria:

* History of macular or chorioretinal inflammation
* Lens / corneal opacities
C: 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
D: Inclusion Criteria:

1. best-corrected visual acuity (BCVA) between 0.0 and 1.0 logarithm of the minimal angle of resolution (logMAR)
2. presence of subfoveal fluid persisting for 3 months or more on optical coherence tomography (OCT)
3. presence of leakage and multifocal/diffuse RPE decompensation on fluorescein angiography (FA)
4. choroidal vascular hyperpermeability and abnormal dilation of choroidal vasculature on indocyanine angiography (ICGA)

Exclusion Criteria:

1. previous treatment, such as laser photocoagulation, PDT, intravitreal injection of steroid or anti-VEGF agent
2. evidence of choroidal neovascularization
3. any other ocular diseases that could affect visual acuity
4. systemic steroid treatment in the previous 12 months
5. media opacity such as cataract that could interfere with adequate acquisition of OCT, FA and ICGA images

Answer: C