Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Bausch & Lomb Incorporated
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01060787
First received: January 29, 2010
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

Investigate the impact of the Fluocinolone Acetonide (FA) intravitreal implants on corneal endothelial cell density.


Condition Intervention
Inflammation
Uveitis
Procedure: Fluocinolone Acetonide 0.59 mg
Procedure: Fluocinolone Acetonide 2.1 mg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Corneal Endothelial Cell Density [ Time Frame: 1 Visit ] [ Designated as safety issue: No ]
    Bilateral specular microscopy will be performed and endothelial cell density will be recorded.


Estimated Enrollment: 100
Study Start Date: August 2006
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fluocinolone Acetonide 0.59 mg
Participants who have had the fluocinolone acetonide (FA) drug delivery system 0.59 mg surgically implanted in the ocular vitreous chamber of one (1) eye for at least one (1) year.
Procedure: Fluocinolone Acetonide 0.59 mg
At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
Other Name: Retisert
Fluocinolone Acetonide 2.1 mg
Participants who have had the fluocinolone acetonide (FA) drug delivery system 2.1 mg surgically implanted in the ocular vitreous chamber of one (1) eye for at least one (1) year.
Procedure: Fluocinolone Acetonide 2.1 mg
At a single visit bilateral endothelial microscopy will be performed to determine endothelial cell density.
Other Name: Retisert

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects having the fluocinolone acetonide intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one (1) year.

Criteria

Inclusion Criteria:

  • Had the FA intravitreal implant (0.59 or 2.1 mg) in only one eye for at least one(1) year
  • Able and willing to follow instructions
  • Able and willing to provide informed consent

Exclusion criteria:

  • Is monocular
  • Has current or relevant medical history that would interfere with their participation in this study, based on the judgment of the Investigator
  • Had bilateral FA intravitreal implants
  • Has a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060787

Contacts
Contact: Michael S Zhang 973-360-6448 michael.zhang@bausch.com

Locations
United States, Massachusetts
Ophthalmic Partners of Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Michael Raziman, MD         
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01060787     History of Changes
Other Study ID Numbers: 440
Study First Received: January 29, 2010
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014