Fluocinolone acetonide sustained drug delivery device to treat severe uveitis

doi:10.1016/S0161-6420(00)00466-8

Ophthalmology

Volume 107, Issue 11, November 2000, Pages 2024-2033

https://doi.org/10.1016/S0161-6420(00)00466-8 Get rights and content

Abstract

Purpose

Uveitis is often a chronic disease requiring long-term medical therapy. In this report, we describe a pilot safety and efficacy trial of a novel sustained drug delivery system containing fluocinolone acetonide to treat patients with severe uveitis.

Design

Prospective, noncomparative, interventional case series

Participants

Patients with severe uveitis.

Methods

Sustained drug delivery devices designed to release fluocinolone acetonide for at least 2.5 years were implanted through the pars plana into the vitreous cavity of seven eyes of five patients. All patients had severe uveitis not well controlled with, or intolerant to, repeated periocular corticosteroid injections, systemic corticosteroids, nonsteroidal immunosuppressive agents, or a combination thereof at the time of device implantation. Before device implantation, patients underwent complete evaluation including history, ophthalmologic examination, fluorescein angiography, visual field testing, and electroretinography. After surgery, patients were reexamined at 1 week, 2 weeks, 4 weeks, and at 1- to 3-month intervals. Visual fields, electroretinograms, and fluorescein angiography were repeated at 3- to 6-month intervals.

Main outcome measures

Preoperative and postoperative visual acuity, ocular inflammation, anti-inflammatory medication use, and intraocular pressure.

Results

Patients had a diagnosis of Behçet’s syndrome (two eyes), or idiopathic panuveitis (five eyes, including two with necrotizing retinitis, two with progressive chorioretinitis, and one with iridocyclitis and intermediate uveitis). Patients were observed an average of 10 months (range, 5–19 months). All eyes had stabilized or improved visual acuity after device implantation, and four of seven eyes had an improvement of three lines or more. The mean initial visual acuity, measured by Snellen chart, was 20/207, and the mean final visual acuity was 20/57 (P = 0.02). After surgery, at the final visit, no eye had clinically detectable inflammation, and all seven eyes had a marked reduction in systemic, topical, and periocular anti-inflammatory medication use. Four eyes had increased intraocular pressure 6 weeks to 6 months after device implantation. Intraocular pressure has been controlled on topical medications. No patient experienced intraoperative complications.

Conclusions

A fluocinolone acetonide sustained drug delivery device is a promising new therapy for the treatment of severe uveitis. Intraocular pressure must be carefully monitored long after device implantation. Based on these data, a randomized study of a larger group of patients is warranted.

Section snippets

Patients and methods

Patients included in this report were recruited to the Duke University Eye Center or to the Assaf-Hrophe Medical Center and accrued prospectively from April 1998 through September 1999. Patients 1 through 4 were referred to the Duke Eye Center and seen by one of us (GJJ). Patient 5 was evaluated and treated at the Assaf-Hrophe Medical Center by another of us (JBN). A compassionate use Investigational New Drug exemption was obtained from the Food and Drug Administration to place fluocinolone

Results

A detailed description of patient demographics, initial ophthalmologic history and examination findings, postoperative course, and medications administered is provided in Table 1, Table 2. Patients had a diagnosis of Behçet’s syndrome (two eyes), or idiopathic panuveitis (five eyes, including two with necrotizing retinitis, two with progressive chorioretinitis, and one with iridocyclitis and intermediate uveitis). The mean uveitis duration before device implantation was 6 years (range, 3–20

Discussion

In this report, we have shown that a fluocinolone acetonide sustained drug delivery device can be used to treat patients with severe uveitis. We observed favorable effects on inflammation; preservation or improvement of visual acuity; reversal of cystoid macular edema; reduction or elimination of topical, periocular, or systemic anti-inflammatory mediations or a combination thereof; and preservation of the electroretinogram as objective indicators of fluocinolone acetonide device efficacy. The

Acknowledgements

The authors thank Drs. J. Daniel Bobbitt, Michael Antworth, and Careen Lowder, who referred patients for fluocinolone acetonide device implantation, and Dr. Terry Cox, who assisted with the statistical analysis.

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^☆: Supported by the National Eye Institute, Bethesda, Maryland (grant nos.: EYO9106 [GJJ] and EYO05722 [Duke Eye Center]).

⁶: Dr. Jaffe is a Lew R. Wasserman Merit Award Recipient.

⁸: Drs. Jaffe, Dunn, and Ben-nun do not have a proprietary interest in the device.

⁷: Drs. Ashton and Guo are employees of Control Delivery Systems, Inc., and, as such, may have a financial interest in the fluocinolone acetonide device.

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Fluocinolone acetonide sustained drug delivery device to treat severe uveitis☆

Abstract

Purpose

Design

Participants

Methods

Main outcome measures

Results

Conclusions

Section snippets

Patients and methods

Results

Discussion

Acknowledgements

Ophthalmology

Ophthalmology

Ophthalmology

Ophthalmology

UveitisFundamentals and Clinical Practice