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B.D. Kuppermann, G.A. Williams, M.S. Blumenkranz, P. Dugel, J.A. Haller, C. Chou, S.M. Whitcup; Efficacy and Safety of a Novel Intravitreous Dexamethasone Drug–Delivery System After Applicator or Incisional Placement in Patients With Macular Edema . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5913.
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© ARVO (1962-2015); The Authors (2016-present)
Evaluate the safety and efficacy of dexamethasone in an intravitreous drug–delivery system (DDS) in patients with macular edema (ME) and compare the safety of applicator and incisional placement of the DDS.
Two studies were conducted. One was a multicenter, randomized, single–masked study in patients with persistent ME refractory to medical or laser treatment. Patients were randomized to observation or treatment with 350µg or 700µg dexamethasone in a surgically implanted DDS (n=105 per group). In the second study, ME patients were randomized to insertion of 700µg dexamethasone DDS via a 22–gauge applicator system (n=20) or by incisional placement (n=10). Outcome measures included best–corrected ETDRS visual acuity (VA), intraocular pressure (IOP), and adverse events.
In the first study, VA improved by ≥15 letters in 18.1% of patients in the 700µg group vs 5.7% in the observation group at day 90 (P=.006); this persisted through day 180. In the second study, VA was improved by ≥15 letters in 20% of eyes in both dexamethasone DDS groups at day 180. The dexamethasone DDS was well tolerated. In the first study, reports of cataract were similar among all study groups, and only 2% of treated patients and 1% of observed patients had an IOP increase of ≥10 mm Hg at day 90. All cases of increased IOP were managed with observation or topical medications. There were no cases of treatment–related endophthalmitis or retinal detachment. In the second study, applicator placement was quicker than incisional placement. Sutures were needed to close the insertion wound for all eyes in the incisional group but none in the applicator group. The incidence of ocular adverse events was lower in the applicator group than in the incisional group. Two patients in the incisional group and none in the applicator group had an IOP increase of ≥10 mm Hg at day 180. Vitreous hemorrhage occurred in 2 eyes in the incisional group and no eyes in the applicator group.
In patients with persistent macular edema, 700µg dexamethasone in a novel DDS produced sustained, clinically meaningful improvements in visual acuity and was well tolerated. Applicator placement of the DDS was quicker than incisional placement, was at least as safe, and produced similar beneficial effects on visual acuity.
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