Central Serous Chorioretinopathy (CSCR) Eye Diseases
Conditions
Interventions
This is a multicentre, double masked, placebo controlled randomised trial comparing half dose photodynamic therapy (PDT) using verteporfin with placebo infusion plus laser in adults with chronic centr
Sponsors
University of Bristol - Bristol Trials Centre
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Participants must be aged 18 years or above. 2. Must have visual impairment due to Central Serous Chorioretinopathy (CSCR) of more than 4 months duration. This is defined by the subfoveal presence of subretinal fluid (SRF) on Optical Coherence Tomography (OCT) with a vertical thickness of at least 50 microns, along with the characteristic appearance of CSCR on Fundus Fluorescein Angiography (FFA) and Indocyanine Green Angiography (ICGA). 3. The study eye must have a best recorded visual acuity (BRVA) score of less than 70 ETDRS letters (equivalent to 6/12 Snellen). 4. The study eye must have clear ocular media and adequate pupillary dilatation to permit photography. 5. Participants must be able to provide written informed consent. 6. Women of childbearing potential must have a negative pregnancy test and be willing to use effective contraception. Women who are post-menopausal for over 12 months or are surgically sterile are also eligible.
Exclusion criteria
Exclusion criteria: General Exclusions: 1. Known hypersensitivity to verteporfin, iodine, sodium iodide, fluorescein, or indocyanine green. 2. Diagnosis of porphyria or a history of severe hepatic impairment (Child-Pugh score >6). 3. Currently breastfeeding. 4. Severe or end-stage renal impairment, defined as an estimated glomerular filtration rate (eGFR) of less than 15. 5. Current use of other photosensitising medicinal products, such as tetracyclines, sulphonamides, phenothiazines, and thiazide diuretics. 6. Use of any oral medication for the specific purpose of treating CSCR (e.g., eplerenone, spironolactone, rifampicin) within the last 6 months. 7. Use of oral corticosteroids within the last 3 months. 8. Participation in another clinical trial involving an Investigational Medicinal Product (IMP) within the last 30 days. Exclusions Specific to the Study Eye: 1. Evidence of choroidal neovascularization as seen on FFA, ICGA, or OCT-A. 2. Presence of subfoveal retinal pigment epithelial atrophy. 3. Any previous treatment with photodynamic therapy (PDT). 4. Receipt of any anti-VEGF therapy or previous thermal or micropulse laser therapy for CSCR within the last 6 months. 5. Presence of any other ocular disease which could be a cause of retinal or subretinal fluid accumulation, such as diabetic retinopathy. 6. Myopia greater than -6 dioptres.
Countries
England, Northern Ireland, United Kingdom
Contacts
Public ContactAndrew Lotery
Outcome results
None listed