Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02841306
Study type Interventional
Source University of Lausanne
Contact
Status Completed
Phase Phase 1
Start date July 2016
Completion date September 2017

See also
  Status Clinical Trial Phase
Recruiting NCT04403750 - Combined Laser-surgical Technology of RRD Treatment N/A
Not yet recruiting NCT04520789 - Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencingvitreoretinopathy N/A
Recruiting NCT04571788 - Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle
Completed NCT02834559 - Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment. Phase 3
Recruiting NCT01845571 - Retinal Detachment - Demographic and Clinical Survey
Completed NCT04891991 - Intravitreal Infliximab for Proliferative Vitreoretinopathy Phase 2
Recruiting NCT02871531 - Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment in Patients With Extended Criteria N/A
Completed NCT00757536 - Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment N/A
Active, not recruiting NCT00370201 - Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment Phase 3
Completed NCT00345007 - Macular Function After Scleral Buckle N/A
Recruiting NCT05331664 - Dropless Pars Plana Vitrectomy Study Phase 4
Not yet recruiting NCT02185469 - Corneal Endothelial Cell Loss After Pneumatic Retinopexy for the Repair of Primary Rhegmatogenous Retinal Detachment N/A
Not yet recruiting NCT01647373 - Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling N/A
Completed NCT01068379 - Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation Phase 3
Not yet recruiting NCT06425419 - The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy Phase 1
Not yet recruiting NCT06468397 - Acute Retinal Detachment Repair With the iSeelr^TM Retinal Detachment Repair System N/A
Recruiting NCT06056596 - Lamivudine and Plasma Markers of Inflammation in Retinal Detachment Early Phase 1
Completed NCT01343134 - Anatomical and Functional Macular Changes in Retinal Detachment N/A
Recruiting NCT05588037 - Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery N/A
Completed NCT03542162 - Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment N/A