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

Phase 1

• Conditions: on-infectious Uveitis affecting posterior segment of the eye; MedDRA version: 4.1Level: LLTClassification code 10036370

• Registration Number: EUCTR2005-001589-15-GB
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-09
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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
successful outcome (reduction to 21 mmHg or less) lasting at least 3 months
prior to enrollment.

9. Ocular surgery and /or trauma on the study eye within 3 months prior to
enrollment or trabeculoplasty or YAG laser within one month prior to enrollment

10. Female pregnant, lactating, or of childbearing potential considering
becoming pregnant during the course of the study and those not taking
effective contraception/precautions to avoid pregnancy

11. Patient for whom, in the physician’s opinion, any of the protocol procedures
may pose a special risk not outweighed by the potential benefits of participating
in the study.

12. Uveitis of infectious etiology

13. Patient who has been tested positive for human immunodeficiency virus.

14. Patient who is currently enrolled in any other clinical study or who has
participated in any clinical study other than BLP415-002 within 1 month of
enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified