EUCTR2012-004555-36-FR
Active, not recruiting
Phase 1
A prospective randomized controlled multicentre trial comparing half-dose photodynamic therapy (PDT) with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy (CSC).
Centre Hospitalier Intercommunal de Créteil0 sites140 target enrollmentJune 18, 2015
ConditionsChronic central serous chorioretinopathyMedDRA version: 18.0 Level: PT Classification code 10063118 Term: Chorioretinopathy System Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsVISUDYNE
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic central serous chorioretinopathy
- Sponsor
- Centre Hospitalier Intercommunal de Créteil
- Enrollment
- 140
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 (\< 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
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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
A prospective randomized controlled multicenter trial of catheter and papillotome: effect on selective cannulation of the common bile duct in endoscopic retrograde cholangiopancreatographyPancreaticobiliary diseaseJPRN-UMIN000002572Hokkaido University Hospital, Department of Gastroenterology400
Completed
Not Applicable
A prospective randomized controlled multicenter trial to reduce the incidence of clinical pancreatic fistula after distal pancreatectomyPancreatic disease required distal pancreatectomyJPRN-UMIN000007426Hiroshima University Hospital80
Completed
Not Applicable
A prospective randomized controlled multicenter trial of precut and endoscopic ultrasound-guided rendezvous procedure: effect on selective bile duct cannulation in difficult bile duct cannulation using conventional techniquePancreatobiliary diseasesJPRN-UMIN000013918Department of Gastroenterology and Hepatology194
Completed
Not Applicable
A prospective randomized controlled multicenter trial of safety and efficacy of endoscopic sphincterotomy in placement of covered self-expandable metallic stent for biliary obstruction from unresectable pancreatic cancer.biliary obstruction from unresectable pancreatic cancerJPRN-UMIN000004044Fourth Department of Internal Medicine, Sapporo medical university200
Not yet recruiting
Phase 3
A multicenter prospective randomized controlled trial: Comparison generic alginate Vs original alginate for symptoms controlled in the non-proton pump inhibitors responder GERDIn patients with gastroesophageal reflux disease, despite taking proton pump inhibitors But only 25.7% of symptoms could be controlled in 7 days and only 35.9% of GERD patients were found to have no heartburn symptoms over 28 days. Patients with GERD are chronic and affect their quality of life worse compared to normal people. which often affects sleep decreased vitality more pain in the body impaired sexual feelings and more anxiety.GERDTCTR20230119007Dr. Kawin Tangvoraphonkchai162