Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant

NCT03145025 | Completed DMC FDA Drug FDA Device

• 1 other identifier: 853
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Uveitis, Posterior

Outcome Measures

Primary Outcomes (1)

• The primary safety endpoint is change from baseline in endothelial cell density (ECD) in the study eye one year following implantation.

  1 year

Interventions

Retisert DEVICE

Intravitreal Implant

Fluocinolone Acetonide Intravitreal Implant DRUG

Intravitreal Implant

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Are scheduled for surgical placement of a Retisert fluocinolone acetonide (FA) intravitreal implant in a previously unimplanted eye.
• Are able and willing to comply with all treatment and follow up/study procedures.
• 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.
• 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

You may not qualify if:

• 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."
• 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.
• 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
• Is monocular (unable to detect hand motion at 6 feet in 1 eye).
• Has a known corneal dystrophy or corneal transplant.
• 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).
• Had any type of intraocular drug delivery implant (eg, Retisert, Ozurdex \[dexamethasone intravitreal implant\]) in the study eye.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Valeant Site 001

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Uveitis, Posterior

Interventions

Fluocinolone Acetonide

Condition Hierarchy (Ancestors)

Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 9, 2017
• Study Start: July 14, 2017
• Primary Completion: September 10, 2018
• Study Completion: March 22, 2019
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)