An observational study in Uveitis, Posterior, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 12 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-21.
Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Observational
An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated with a Fluocinolone Acetonide Intravitreal Implant
This is a prospective, multicenter, open-label, single arm, observational evaluation of the corneal ECD change from baseline for subjects having the Retisert FA drug delivery system (0.59 mg) surgically implanted in the ocular vitreous chamber of at least 1 previously unimplanted eye for at least 1 year.
61 studies on the registry are indexed under Uveitis, Posterior; 4 are open to participants now.
This study's enrollment of 3 is below the median of 42 across 10 observational studies indexed under Uveitis, Posterior.
Browse Uveitis, Posterior studies →Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.
First submitted after Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..
Counted across the registry records on this site, refreshed daily.
Subjects having the Retisert FA drug delivery system (0.59 mg) surgically implanted in the ocular vitreous chamber of at least 1 previously unimplanted eye for at least 1 year
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Note: Should a subject conceive during the study, the pregnancy should be reported as soon as possible to the study Medical Monitor and Promedica International within 24 hours. The pregnancy will be followed up to term. The subject will continue in the studyregardless if pregnancy is reported on an AE/SAE form. If an Investigator becomes aware of a post study pregnancy 30 days after the study exit visit while Fluocinolone Acetonide Implant remains in the subject's study eye, then it should be reported as a post-marketing report
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravitreal Implant
Intravitreal Implant
The primary safety endpoint is change from baseline in endothelial cell density (ECD) in the study eye one year following implantation.
Time frame: 1 year
Plan to share: Yes
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Sep 2018, 13 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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