Chronic central serous chorioretinopathy MedDRA version: 18.0 Level: PT Classification code 10063118 Term: Chorioretinopathy System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: VISUDYNE
Pharmaceutical Form: Powder for solution for infusion
Sponsors
Centre Hospitalier Intercommunal de Créteil
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • male and female patients = 18 years of age who are able to give written informed consent • active chronic central serous chorioretinopathy • decline in best-corrected visual acuity/BCVA ( 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • 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 6D • visual loss and/or serous detachment on OCT 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether half-dose PDT treatment leads to a higher percentage of chronic CSC patients with subretinal fluid on optical coherence tomography (OCT) scanning achieving an absence of this subretinal fluid on OCT as compared to HSML treatment.;Secondary Objective: To investigate the clinical outcome comparing half-dose PDT treatment with HSML treatment in patients with subretinal fluid due to active leakage in chronic CSC, based on evaluation of best-corrected visual acuity, retinal sensitivity on microperimetry, and subjective success score on the NEI VFQ-25 questionnaire of visual functioning;Primary end point(s): The primary endpoint of this study is to assess if there is a difference between the efficacy of half-dose PDT treatment versus HSML treatment in patients with chronic CSC. ;Timepoint(s) of evaluation of this end point: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints that will be assessed as a reflection of functional improvement after treatment include: - Number of second treatments needed in each treatment arm - 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, among the two treatment modalities - Mean change from Evaluation Visit 1 in ETDRS BCVA in the study eye at final evaluation (7-8 months after Treatment Visit 1), among those who required one treatment and those who required a second treatment, and among the two treatment modalities overall - Mean change from baseline in retinal sensitivity on microperimetry in the study eye at 6-8 weeks after Treatment Visit 1 and at 7-8 months after Treatment Visit 1 among the two treatment modalities - Mean change from baseline in the NEI VFQ-25 questionnaire at 6-8 weeks after Treatment Visit 1 and at 7-8 months after Treatment Visit 1 among the two treatment modalities - An absence of subretinal fluid on evaluation with OCT scanning as compared to HSML treatment at 7-8 months follow-up after successful treatment (after Treatment Visit 1; “success” defined as an absence of subretinal fluid on OCT at 6-8 weeks after treatment) ;Timepoint(s) of evaluation of this end point: 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). | — |
Countries
France
Contacts
Public ContactPrincipal Investigator
Centre Hospitalier de CRETEIL
Outcome results
None listed