Posterior Uveitis Clinical Trial
Official title:
Combined Fluocinolone Acetonide Sustained Drug Delivery System Implantation and Phacoemulsification/Intraocular Lens Implantation in Patients With Severe Uveitis
Verified date | August 2008 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
To review chart data at the Duke Eye Center and determined whether a 3-year fluocinolone acetonide sustained drug delivery system (FA) safely suppressed postoperative inflammation when combined with phacoemulsification and posterior chamber intraocular lens implantation (phaco/PCIOL) in eyes with severe uveitis.
Status | Completed |
Enrollment | 21 |
Est. completion date | May 2008 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - A visually significant cataract - A history of recurrent noninfectious posterior uveitis or intermediate uveitis with or without iridocyclitis - incomplete therapeutic response or treatment-limiting side effects to oral, periocular corticosteroid, and/or immunosuppressive agents - VA of at least light perception; and - Ability to comprehend informed consent and comply with follow-up examinations Exclusion Criteria: - An allergy to fluocinolone acetonide or any component of the delivery system - A toxoplasmosis scar was present in the study eye, - A peripheral retinal detachment (RD) in the area of the planned fluocinolone acetonide implant placement - Required chronic systemic corticosteroid therapy or systemic immunosuppressive therapy to treat non-ocular disease or if they tested positive for human immunodeficiency virus. - Also excluded were female patients who were pregnant or lactating or not taking precautions to avoid pregnancy. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Foster CS, Fong LP, Singh G. Cataract surgery and intraocular lens implantation in patients with uveitis. Ophthalmology. 1989 Mar;96(3):281-8. — View Citation
Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. Epub 2006 May 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preoperative and postoperative ocular inflammation | up to 12 months postoperatively | Yes | |
Secondary | visual acuity | up to 12 months postoperatively | No |
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