Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery

Recruiting Phase 3 Interventional Study
Retinal Detachment
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Hopital Foch · Other
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About This Trial
This study is indicated for patients with extended rhegmatogenous retinal detachment (RRD) (≥ 2 quadrants) with macula OFF lasting 7 days or less, pseudophakic or aphakic, and scheduled to undergo surgical intervention with vitrectomy and gas tamponade in one of the ophthalmology departments participating in the study. The main objective is to assess the effectiveness of UDCA in visual acuity rec…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Aged 18 years or older, 2. Scheduled to undergo surgical intervention through vitrectomy, 3. Aphakic or pseudophakic patients, 4. Experiencing rhegmatogenous retinal detachment affecting 2 quadrants or more, 5. Presenting with macula OFF (raised macula) for 7 days or less bef…
Contacts

BEHAR COHEN Francine

0146252275

f.behar-cohen@hopital-foch.com

CONTACT