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Ursodeoxycholic Acid for Rhegmatogenous Retinal Detachment (UDCA-RD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841306
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
University of Lausanne Hospitals
Emory University
Information provided by (Responsible Party):
Francine Behar-Cohen, University of Lausanne

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.


Condition or disease Intervention/treatment Phase
Rhegmatogenous Retinal Detachment Drug: Ursodeoxycholic Acid Phase 1

Detailed Description:

Retinal detachments consist in a separation of the neuroretina from the retinal pigment epithelium. The most common form is rhegmatogenous retinal detachment (RRD), which occurs as a result of a full-thickness retinal break and the presence of vitreoretinal tractions. Photoreceptor cell death occurs rapidly after RRD and is the ultimate cause of vision loss in these patients. Reattachment of the retina by a surgical procedure allows a recovery of vision. However, the degree of visual recovery differs among patients, despite successful reattachment. This is mainly related to the preoperative visual acuity level, the presence of a macular detachment and its duration. Predicting factors of worse visual acuity are the height of retinal detachment in the macula and the presence of edema, separation, cyst and undulation at the level of the outer nuclear layer showed by optical coherence tomography (OCT). Most patients usually consult with a RRD already involving the macular area after 3 days or more, leading to a worse visual prognostic even with successful surgery. The need for adjuvant neuroprotective agents is then critical to improve photoreceptor survival, functional recovery and subsequent quality of life in patients affected by RRD.

Tauroursodeoxycholic acid (TUDCA) is the taurine conjugate of ursodeoxycholic acid (UDCA), a secondary bile acid produced by intestinal bacteria. UDCA was approved by the Food and Drug Administration (FDA) for the treatment of cholestatic liver disease. Both UDCA and TUDCA are potent inhibitors of apoptosis, in part by interfering with the upstream mitochondrial pathway of cell death, inhibiting oxygen-radical production, reducing endoplasmic reticulum (ER) stress, and stabilizing the unfolded protein response (UPR). TUDCA has been proposed as anti-apoptotic agent in several neurodegenerative diseases, including amyotrophic lateral sclerosis, Alzheimer's, Parkinson's, and Huntington's diseases.

In certain degenerative retinal disorders, such as retinitis pigmentosa, TUDCA plays an important role in preventing cell death. In an animal model of RRD, systemic treatment by TUDCA has been shown to protect photoreceptors from cell death.

The aim of this study is to determine whether detectable levels of UDCA reach the vitreous cavity when administered orally at different time points before surgery for RRD, and to analyze its ocular safety.

20 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 16 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ursodeoxycholic Acid (UDCA) as Adjuvant Treatment for Rhegmatogenous Retinal Detachment: a Phase I Pilot Study
Actual Study Start Date : July 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ursodiol

Arm Intervention/treatment
Active Comparator: 3-5 hours
Duration between oral UDCA intake and surgery of 3-5 hours.
Drug: Ursodeoxycholic Acid
Active Comparator: 6-8 hours
Duration between oral UDCA intake and surgery of 6-8 hours.
Drug: Ursodeoxycholic Acid
Active Comparator: 9-12 hours
Duration between oral UDCA intake and surgery of 9-12 hours.
Drug: Ursodeoxycholic Acid
Active Comparator: > 12 hours
Duration between oral UDCA intake and surgery of >12 hours.
Drug: Ursodeoxycholic Acid
No Intervention: Control
No medication



Primary Outcome Measures :
  1. UDCA levels in samples from the vitreous [ Time Frame: 0-8 months ]
    concentration in ng/ml


Secondary Outcome Measures :
  1. UDCA levels in samples from the sub retinal fluid [ Time Frame: 0-8 months ]
    concentration in ng/ml

  2. UDCA levels in samples from the aqueous humor [ Time Frame: 0-8 months ]
    concentration in ng/ml



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting a rhegmatogenous retinal detachment with more than 4 days from symptoms onset.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841306


Locations
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Switzerland
University of Lausanne
Lausanne, Switzerland
Sponsors and Collaborators
Francine Behar-Cohen
University of Lausanne Hospitals
Emory University
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Responsible Party: Francine Behar-Cohen, Professor, University of Lausanne
ClinicalTrials.gov Identifier: NCT02841306    
Other Study ID Numbers: 2016-00644
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents