Please select the arm or intervention descriptions that belong 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: Arm Label: Selective Retinatherapy (SRT); Type: EXPERIMENTAL; Interventions: Device: Selective Retina Therapy (SRT) | Arm Label: control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: crossover; Type: EXPERIMENTAL; Interventions: Device: Selective Retina Therapy (SRT) | Intervention Type: DEVICE; Name: Selective Retina Therapy (SRT); Assigned to Arm(s): Selective Retinatherapy (SRT), crossover
B: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: subthreshold micropulselaser, Drug: bevacizumab | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Device: subthreshold micropulselaser | Arm Label: 3; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: subthreshold micropulselaser; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: bevacizumab; Assigned to Arm(s): 1
C: Arm Label: Half-dose photodynamic therapy (PDT); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Half-dose photodynamic therapy (PDT) | Arm Label: Micropulse laser (ML) treatment; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Micropulse laser (ML) treatment | Intervention Type: PROCEDURE; Name: Half-dose photodynamic therapy (PDT); Assigned to Arm(s): Half-dose photodynamic therapy (PDT) | Intervention Type: PROCEDURE; Name: Micropulse laser (ML) treatment; Assigned to Arm(s): Micropulse laser (ML) treatment
D: Arm Label: Low-fluence PDT with Verteporfin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Verteporfin | Arm Label: Ranibizumab; Type: ACTIVE_COMPARATOR; Interventions: Drug: ranibizumab | Intervention Type: DRUG; Name: Verteporfin; Assigned to Arm(s): Low-fluence PDT with Verteporfin | Intervention Type: DRUG; Name: ranibizumab; Assigned to Arm(s): Ranibizumab

Answer: C