Ursodeoxycholic Acid for Rhegmatogenous Retinal Detachment
UDCA-RD
Ursodeoxycholic Acid (UDCA) as Adjuvant Treatment for Rhegmatogenous Retinal Detachment: a Phase I Pilot Study
1 other identifier
interventional
26
1 country
1
Brief Summary
26 patients presenting a rhegmatogenous retinal detachment with more than 4 days of duration will be prospectively included. A single dose of ursodeoxycholic acid will be administered orally before surgery at different time-points in 22 subjects. Standard surgery will be performed and ocular samples will be collected during the procedure. Ursodeoxycholic acid treatment will be continued in treated patients during 3 months after surgery. Ocular and serum samples from the 4 untreated patients will serve as negative controls for the determination of UDCA levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 17, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedApril 25, 2019
April 1, 2019
1.2 years
July 17, 2016
April 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
UDCA levels in samples from the vitreous
concentration in ng/ml
0-8 months
Secondary Outcomes (2)
UDCA levels in samples from the sub retinal fluid
0-8 months
UDCA levels in samples from the aqueous humor
0-8 months
Study Arms (5)
3-5 hours
ACTIVE COMPARATORDuration between oral UDCA intake and surgery of 3-5 hours.
6-8 hours
ACTIVE COMPARATORDuration between oral UDCA intake and surgery of 6-8 hours.
9-12 hours
ACTIVE COMPARATORDuration between oral UDCA intake and surgery of 9-12 hours.
> 12 hours
ACTIVE COMPARATORDuration between oral UDCA intake and surgery of \>12 hours.
Control
NO INTERVENTIONNo medication
Interventions
Eligibility Criteria
You may qualify if:
- Patients presenting a rhegmatogenous retinal detachment with more than 4 days from symptoms onset.
You may not qualify if:
- Previous vitrectomy, vitreous bleeding, other associated retinal disease.
- Monophthalmic patients.
- Pregnancy and lactation, peptic ulcer, acute or chronic liver disease, acute infection of the gallbladder and biliary tract, repeated biliary colic, Crohn's disease, ulcerative colitis, or other disease of the small intestine and colon, and hypersensitivity.
- Patients treated by Cholestyramine, Colestipol and Antacids containing aluminum hydroxide or magnesium, Cyclosporine, Ciprofloxacin, Nitrendipine, Dapsone.
- Patients presenting with galactose intolerance, the Lapp lactase deficiency or glucose and galactose malabsorption.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Francine Behar-Cohenlead
- University of Lausanne Hospitalscollaborator
- Emory Universitycollaborator
Study Sites (1)
University of Lausanne
Lausanne, Switzerland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 17, 2016
First Posted
July 22, 2016
Study Start
July 1, 2016
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
April 25, 2019
Record last verified: 2019-04