The safety profile of long-term, high-dose intraocular corticosteroid delivery.
OBJECTIVE
To report the feasibility and safety profile of 2-mg and 6-mg fluocinolone acetonide implants after long-term follow-up in eyes with choroidal neovascularization (CNV).


METHODS
Prospective, noncomparative, interventional case series of patients with non-age-related subfoveal choroidal neovascularization enrolled in a compassionate use protocol.


METHODS
Sustained drug delivery devices containing either 2 mg (eight eyes) or 6 mg (six eyes) of fluocinolone acetonide were implanted through the pars plana into the vitreous cavity of 14 patients with predominantly classic, subfoveal CNV. The main outcome measures were complications related to the device. Secondary outcome measures were involution of established CNV, inhibition of recurrent CNV, and visual acuity.


RESULTS
Patients had a diagnosis of ocular histoplasmosis (seven), myopic degeneration (four), angioid streaks (two), and punctate inner choroidopathy (one). Patients were followed for an average of 33 months (range, 16 to 40 months). All 14 eyes developed elevated intraocular pressure and cataract. Four eyes developed nonischemic central retinal vein occlusion. Complications required implant removal in 8 eyes. Ten of 14 eyes demonstrated involution of CNV or inhibition of recurrent CNV. Ten eyes had stable or improved visual acuity. Median initial visual acuity was 20/64. Median final visual acuity was 20/40.


CONCLUSIONS
Long-term follow-up demonstrates a significant complication rate with the sustained release of high-dose intraocular corticosteroids. The complications are treatable, and eyes can retain good vision. This therapeutic approach warrants further study to identify if lower doses of corticosteroids may reduce the complication rate yet still be effective in treating ocular disease.
Holekamp
Nancy M
NM
Barnes Retina Institute, St. Louis, Missouri 63144, USA. Nholekamp@pol.net
Thomas
Matthew A
MA
Pearson
Andrew
A
D000328:Adult; D000793:Angioid Streaks / Q000150:complications; D002386:Cataract / Q000139:chemically induced; D015862:Choroid Diseases / Q000150:complications; D020256:Choroidal Neovascularization / Q000188:drug therapy* / Q000209:etiology; D016503:Drug Delivery Systems; D004343:Drug Implants; D005240:Feasibility Studies; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage* / Q000009:adverse effects; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006660:Histoplasmosis / Q000150:complications; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D047728:Myopia, Degenerative / Q000150:complications; D009798:Ocular Hypertension / Q000139:chemically induced; D011446:Prospective Studies; D012170:Retinal Vein Occlusion / Q000139:chemically induced; D012449:Safety; D016896:Treatment Outcome; D014792:Visual Acuity
D004343:Drug Implants; D005938:Glucocorticoids; D005446:Fluocinolone Acetonide