Clinical trial NCT03145025: Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
Official title: An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis, Posterior
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 3
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated with a Fluocinolone Acetonide Intravitreal Implant

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Are scheduled for surgical placement of a Retisert fluocinolone acetonide (FA) intravitreal implant in a previously unimplanted eye.
2. Are able and willing to comply with all treatment and follow up/study procedures.
3. Able and willing to provide informed consent or, for subjects 12-18 years of age, have the ability to understand and provide assent (when applicable) and whose parent/legally authorized representative has the ability to understand and provide written informed consent on the Institutional Review Board (IRB) approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
4. For female subjects:

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:

1. Has previously, concurrently or anticipated enrollment in Bausch \& Lomb study 440, titled, "An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year."
2. Has severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study, based on the judgment of the Investigator.
3. Has participated in an ophthalmic drug or device research study within 30 days prior to Screening (Visit 1, Day -30 to -1) in this study
4. Is monocular (unable to detect hand motion at 6 feet in 1 eye).
5. Has a known corneal dystrophy or corneal transplant.
6. Has a history of ocular surgery in the eye scheduled for implant surgery, including laser procedures, within the 30 days prior to Screening (Visit 1, Day -30 to -1).
7. Had any type of intraocular drug delivery implant (eg, Retisert, Ozurdex \[dexamethasone intravitreal implant\]) in the study eye.

Primary outcomes:
measure: The primary safety endpoint is change from baseline in endothelial cell density (ECD) in the study eye one year following implantation.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Valeant Site 001
state: Massachusetts
Study officials:
References: