Rhegmatogenous Retinal Detachment Clinical Trial
Official title:
Ursodeoxycholic Acid (UDCA) as Adjuvant Treatment for Rhegmatogenous Retinal Detachment: a Phase I Pilot Study
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.
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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