Clinical Trial: Prospective Randomized Controlled Treatment Trial for Chronic Central Serous Chorioretinopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Prospective Randomized Controlled Multicentre Trial Comparing Half-dose Photodynamic Therapy (PDT) With High-density Subthreshold Micropulse Laser Treatment in Patients With Chronic 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 Nethe

Detailed Summary:

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 worldwide. PDT uses a photosensitive drug, verteporfin (Visudyne®), that is administered once intravenously before treatment with a specific type of laser. PDT treatment has been developed originally as treatment for another form of macular degeneration, age-related macular degeneration, on which there are extensive data available. There are several other retinal diseases for which PDT with verteporfin is successfully used as an off-label treatment. The use of PDT treatment in chronic CSC is based on the high rate of anatomic success, the increase of visual acuity, the improvement in retinal sensitivity, and an excellent safety profile reported in many retrospective studies. The PDT strategies that are generally used are either with half the dose of verteporfin (Visudyne®) and full fluence (energy) of laser treatment, half the fluence level and the full dose of verteporfin, or half the treatment time using the full dose of verteporfin and full fluence, as compared to the original protocol that was used for neovascular age-related macular degeneration. These PDT strategies that use either half-dose of half-fluence treatment have been developed because a combination of the dosage and fluence that was originally used for the treatment of neovascular age-related macular degeneration showed a higher risk of developing choroidal ischemia and retinal atrophic changes. The half-dose and half-fluence PDT strategies, however, have been shown to be safe and effective in relatively large retrospective studies and one non-controlled non-randomized prospective study by Chan et al. in chronic CSC patients with sufficient follow-up periods.

Therefore, tailoring the therapy to obta
Sponsor: Radboud University

Current Primary Outcome: Absence of subretinal fluid on OCT scan [ Time Frame: 6-8 weeks after treatment ]

The primary endpoint of this study is to assess if there is a difference between the efficacy of half-dose photodynamic therapy treatment versus micropulse laser treatment in patients with chronic central serous chorioretinopathy. The assessment of this efficacy will be based on the anatomical effect on optical coherence tomography (OCT): absence of subretinal fluid versus persistent subretinal fluid, 6-8 weeks after treatment. After all, the absence or presence of fluid under the retina on the OCT scan is a direct reflection of the activity of the disease in these patients.


Original Primary Outcome: Same as current

Current Secondary Outcome: Best-corrected visual acuity [ Time Frame: 6-8 weeks and 7-8 months after Treatment Visit 1 ]

As secondary endpoints, we will mainly look at three parameters that reflect the patient's vision-related functioning. These three parameters are: a standardized measurement of best-corrected visual acuity (BCVA) according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) standards, a standardized measurement of sensitivity of the macula with microperimetry, and standardized assessment of the patient's vision-related quality of life using a validated questionnaire, the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).

The secondary endpoint with regard to BCVA that will be assessed as a reflection of functional improvement after treatment includes:

  • Mean change from baseline in ETDRS BCVA in the study eye at 6-8 weeks after Treatment Visit 1 and at 7-8 months after Treatment Visit 1
  • Mean change from Evaluation Visit 1 in ETDRS BCVA in the study eye at final evaluation (7-8 months after Treatment Visit 1)


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: February 21, 2013
Date Started: December 2013
Date Completion: July 2017
Last Updated: April 13, 2017
Last Verified: April 2016