A prospective randomised controlled multicentre trial comparing half-dose photodynamic therapy (PDT) with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy (CSC).
- Conditions
- Chronic central serous chorioretinopathy10047060
- Registration Number
- NL-OMON39842
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 119
- Male and female patients >= 18 years of age who are able to give written informed consent
- Presence of active chronic central serous chorioretinopathy (CSC)
- Subjective visual loss > 6 weeks, interpreted as onset of active disease
- Subretinal fluid that includes the fovea on optical coherence tomography (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
- Hyperfluorescent areas on indocyanin green (ICG) angiography
- >=1 ill-defined hyperfluorescent leakage areas on fluorescein angiography (FA) with retinal pigment epithelial window defect(s) that are compatible with chronic CSC
- 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 > 6D
- 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 FA 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 FA or ICG angiography
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is to assess if there is a difference<br /><br>between the efficacy of half-dose PDT treatment versus HSML treatment in<br /><br>patients with chronic CSC. The assessment of this efficacy will be based on the<br /><br>anatomical effect on optical coherence tomography (OCT): absence of subretinal<br /><br>fluid versus persistent subretinal fluid, 6-8 weeks after treatment. After all,<br /><br>the absence or presence of fluid under the retina on the OCT scan is a direct<br /><br>reflection of the activity of the disease in these patients.</p><br>
- Secondary Outcome Measures
Name Time Method <p>As secondary endpoints, we will mainly look at three parameters that reflect<br /><br>the patient*s vision-related functioning. These three parameters are: a<br /><br>standardized measurement of best-corrected visual acuity (BCVA) according to<br /><br>the Early Treatment of Diabetic Retinopathy Study (ETDRS) standards, a<br /><br>standardized measurement of sensitivity of the macula with microperimetry, and<br /><br>standardized assessment of the patient*s vision-related quality of life using a<br /><br>validated questionnaire, the National Eye Institute Visual Function<br /><br>Questionnaire (NEI-VFQ-25).</p><br>