Fluocinolone acetonide sustained drug delivery device for chronic central retinal vein occlusion: 12-Month results
ABSTRACT To determine treatment outcomes of a long-acting intravitreal fluocinolone acetonide sustained drug delivery implant in eyes with central retinal vein occlusion (CRVO) and chronic refractory macular edema.
Prospective, noncomparative, interventional case series.
Fourteen eyes of 14 patients with chronically persistent macular edema associated with CRVO underwent intraocular implantation of a three-year fluocinolone acetonide sustained drug delivery system. Best-corrected Early Treatment of Diabetic Retinopathy visual acuity (VA), central foveal thickness determined by optical coherence tomography, and intraocular pressure (IOP) were recorded after the first 12 months after implant insertion.
The median (range) vein occlusion and macular edema duration were 12.5 months (range, seven to 49). No eye experienced intraoperative complications. At baseline, median VA was 20/126, improved to 20/60 by two months, and was 20/80 by 12 months. A significant proportion of eyes had gained lines of VA at 12 months compared with baseline (P = .002). At 12 months, the mean and median central retinal thickness decreased from 622 and 600 microm before surgery, respectively, to 307 and 199 microm after surgery, respectively (P = .008). By month 12, cataract had developed in all five phakic patients, and 13 of 14 eyes required medical or surgical IOP-lowering interventions.
VA improved and macular edema decreased in a significant proportion of implanted eyes with chronic, CRVO-associated macular edema. Cataract formation and elevated IOP, the main side effects, were managed, respectively, with cataract extraction and medical or surgical IOP control, or both. This system is a promising novel alternative to currently available treatments for this challenging patient population.
Article: Drug delivery systems for the eye[Show abstract] [Hide abstract]
ABSTRACT: Topical and systemic administration of drugs to the eye is highly inefficient and there is a need for controlled, sustained release, particularly for conditions that affect the posterior segment. Various nonimplantable and implantable drug delivery devices have been developed. Colloidal carriers may allow targeted drug delivery and afford protection to substances that are sensitive to degradation, particularly RNA/DNA-based treatments. Gene therapy and cell transplantation are also starting to emerge as alternatives to conventional pharmacological treatment. There is the potential to use existing ocular devices to deliver drugs. In order to exploit this opportunity, modifications to drugs and devices, along with clarification of the appropriate drug dose, must be undertaken. This review will describe some of the treatment options for ocular disease and barriers to drug delivery, discuss the design of existing drug delivery systems and highlight some of the research into combining drug delivery with existing ocular medical devices.Expert Review of Medical Devices 06/2009; 6(3):277-90. DOI:10.1586/erd.09.4 · 1.78 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: To examine recent advances in the development of pharmacological agents and drug delivery systems for the treatment of ocular conditions associated with systemic diseases including diabetic retinopathy, retinal vein occlusion, uveitis, and HIV-related retinitis. Corticosteroids, vascular endothelial-derived growth factor antagonists, and anti-inflammatory agents have been investigated for treating ocular conditions associated with systemic diseases. Systemic pharmacotherapy for specifically treating eye diseases is discouraged as side effects may exacerbate preexisting conditions in patients with a debilitating systemic disease. Local therapy with injections into the vitreous has demonstrated varying degrees of efficacy and safety in treating certain ocular diseases; however, its usefulness in some cases can be limited by a short duration of action and the need for frequent readministration. Efforts have been underway to develop more effective drug delivery systems, such as sustained-release drug implants, to overcome these limitations. Pharmacological agents are currently under investigation, and some have been FDA approved, for the treatment of ocular conditions associated with systemic disease. Advances in the development of drug delivery systems for these agents are expected to further improve the efficacy and safety of pharmacotherapy for ocular diseases in the future.Current opinion in ophthalmology 09/2009; 20(6):511-9. DOI:10.1097/ICU.0b013e328330ccb9 · 2.64 Impact Factor
- [Show abstract] [Hide abstract]
ABSTRACT: Diabetic macular edema (DME), cystoid macular edema (CME), age-related macular degeneration (AMD), retinal vascular occlusion (RVO) and uveitis are responsible for severe visual impairment worldwide. In some patients with these conditions, treatment with intraocular corticosteroids may be beneficial. Although off-label use of these agents has occurred for many years, novel agents including preservative-free and sustained-release intravitreal implants are currently being studied in clinical trials (CTs). To review the use of intraocular corticosteroids. Literature review. Used alone, intravitreal corticosteroids may benefit disorders such as DME, RVO and uveitis compared with standard therapy or observation. Patients with AMD may benefit more from combination treatment with photodynamic therapy, intravitreal corticosteroid and intravitreal anti-VEGF injections. Intraoperative use of these agents may assist in visualization and manipulation of fine retinal structures. Sustained-release intraocular implants have been approved for severe posterior uveitis, and have shown benefits in ongoing CTs. Although intraocular corticosteroid injections have a limited duration of action requiring frequent re-treatment, and significant side effects including cataract and glaucoma development, intraocular injections may be of benefit in certain ocular disorders. Corticosteroid implants are emerging as potential treatments for macular edema due to uveitis, DME or RVO.Expert Opinion on Pharmacotherapy 10/2009; 10(15):2511-25. DOI:10.1517/14656560903160671 · 3.09 Impact Factor