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

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

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

Study Overview

• Status: Completed
• Conditions: Uveitis, Posterior
• Intervention / Treatment: Device: Retisert; Drug: 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.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Valeant Site 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 76 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary safety endpoint is change from baseline in endothelial cell density (ECD) in the study eye one year following implantation.	1 year

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2017
• Primary Completion (Actual): September 10, 2018
• Study Completion (Actual): March 22, 2019

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Panuveitis; Uveal Diseases; Uveitis; Uveitis, Posterior; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Fluocinolone Acetonide
• Other Study ID Numbers: 853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes