Fluocinolone acetonide sustained drug delivery device for chronic central retinal vein occlusion: 12-Month results

Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina, USA.
American Journal of Ophthalmology (Impact Factor: 4.02). 07/2008; 146(2):285-291. DOI: 10.1016/j.ajo.2008.03.025
Source: PubMed

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.

  • [Show abstract] [Hide abstract]
    ABSTRACT: Retinal vein occlusion is a major cause of vision loss worldwide, second only to diabetic retinopathy among retinal vascular disorders. A novel bioerodable corticosteroid implant composed of 0.7 mg dexamethasone designed for in-office injection has recently been approved for the treatment of macular edema resulting from retinal vein occlusion, a major mechanism for decreased vision in the condition. Following a single injection, subjects in the Phase III clinical trial achieved three lines of visual acuity improvement significantly faster than subjects who received sham injection. Following repeat injection 6 months later, subjects achieved similar gains with manageable levels of increased intraocular pressure and cataract development. The dexamethasone intravitreal implant is an important option in the management of macular edema following retinal vein occlusion.
    Expert Review of Ophthalmology 01/2014; 8(1). DOI:10.1586/eop.12.69
  • Free Radical Biology and Medicine 11/2011; 51. DOI:10.1016/j.freeradbiomed.2011.10.414 · 5.71 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Glaucoma is the second leading cause of blindness in the United States. Brimonidine tartrate (BT) is a modern anti-glaucoma agent that is currently administered as frequently as a thrice-daily topical eye drop medication. Accordingly, compliance with BT regimens is low, limiting overall effectiveness. One attempt that has previously proven effective to address non-adherence is the formation of ocular inserts, such as the Ocusert ®, whose diffusion based control released an older drug (pilocarpine) for a week-long period. Modern controlled drug release technology provides an avenue for extending the release of practically any drug (including new drugs like BT) for as long as one month from a singular insert. Currently, no controlled release formulations for BT exist. This work outlines the development and characterization of a BT releasing ocular insert designed from poly (lactic co-glycolic) acid (PLGA)/poly ethylene glycol (PEG). We found that a formulation containing 15% PEG can be created that produces a linear BT release profile corresponding to BT eye drop delivery estimates. Additionally, these inserts were shown, through the use of atomic force microscopy and scanning electron microscopy, to have smooth surfaces and physical properties suitable for ophthalmic use.
    Acta biomaterialia 09/2013; DOI:10.1016/j.actbio.2013.09.024 · 5.68 Impact Factor