EUCTR2005-001589-15-GB
Active, not recruiting
Phase 1
A multi-center study evaluating the safety of a replacement intravitreal fluocinolone acetonide (FA) (0.59 mg) implant in patients with non-infectious posterior uveitis who were previously treated with an intravitreal FA implant
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must meet the following criteria to be eligible for enrollment:
- •Implanted patients who have completed approximately 30 months in the 415\-002
- •trial and have experienced a recent recurrence of uveitis, and in the opinion of the
- •Investigator and the Bausch \& Lomb Medical Monitor, would benefit from a
- •replacement implant.
- •AND AT THE TIME OF IMPLANTATION, THE STUDY EYE MUST HAVE:
- •\< 10 anterior chamber cells (A/C) /high\-powered field (HPF) and vitreous haze \<2
- •NOTE: Patients may be treated prior to entry in order to qualify. The objective is to obtain a relatively quiet eye prior to surgery for implantation of implant. All eyes must satisfy this requirement.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
Exclusion Criteria
- •Patients are not eligible for enrollment in this study if any of the following are applicable:
- •1\. Patient who was randomized in the standard of care group in BLP415\-002 study
- •2\. Patient whose previous FA implant was removed due to uncontrolled IOP
- •3\. Presence of vitreous hemorrhage
- •4\. Presence of a recent toxoplasmosis scar in the eye
- •5\. Peripheral retinal detachment
- •6\. Media opacity precluding evaluation of the retina and vitreous
- •7\. Intraocular pressure (IOP) increase to \> 25 mmHg that could not be reduced
- •to 21 mmHg or less by either medical or surgical means.
- •An IOP increase requiring medical or surgical intervention must have a
Outcomes
Primary Outcomes
Not specified
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