Non-infectious Uveitis affecting posterior segment of the eye MedDRA version: 4.1 Level: LLT Classification code 10036370
Conditions
Interventions
Product Name: Fluocinolone Acetonide 0.59mg Intravitreal Implant
Pharmaceutical Form: Ophthalmic insert
INN or Proposed INN: Fluocinolone acetonide
CAS Number: 67-73-2
Concentration unit: mg milligr
Sponsors
Bausch & Lomb Incorporated
Eligibility
Sex/Gender
All
Inclusion 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: =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To observe the safety of the intravitreal fluocinolone acetonide (FA) (0.59 mg) implant in the management of patients with non-infectious uveitis affecting the posterior segment of the eye who were previously treated successfully with an intravitreal FA (0.59 mg ) implant for approximately 30 months and are seeking treatment by means of replacement of the original study implant with a second FA implant.;Secondary Objective: N/A;Primary end point(s): Evaluation of the safety of a second implant | — |
Countries
United Kingdom
Outcome results
None listed