PHOTODYNAMIC THERAPY VERSUS MICROPULSE LASER TREATMENT IN CHRONIC CENTRAL SEROUS CHORIORETINOPATHY

Phase 1

Active, not recruiting

• Conditions: Chronic central serous chorioretinopathy; MedDRA version: 18.0 Level: PT Classification code 10063118 Term: Chorioretinopathy System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-004555-36-FR
• Lead Sponsor: Centre Hospitalier Intercommunal de Créteil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-18
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 140

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 (< 20/20 Snellen equivalent) associated with subjective visual loss > 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

•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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified